48 plytki blokowane 70chlp en - cadeinstruments.com.mx · • comminuted fractures of the distal...

$: 48 Plytki blokowane 70ChLP EN - cadeinstruments.com.mx · • Comminuted fractures of the distal part of the femoral bone and fractures extending to the shaft of the femur. • Supracondylar$
IMPLANTS • INSTRUMENT SETS •

SURGICAL TECHNIQUE •

instruction

LOCKING PLATES 7.0ChLP

0197ISO 9001ISO 13485

48B

3ChM Ltd., Lewickie 3b, 16-061 Juchnowiec K., POLAND

tel. +48 85 713-13-20 ÷ 25 fax +48 85 713-13-19 e-mail: [email protected]

TABLE OF CONTENT

Edition 48B of 05.09.2012 reviewed 31.07.2013

I. INTRODUCTION ....................................................................................................................................... 4

II. PLATE SELECTION AND CONTOURING .............................................................................................. 5V.1. INDICATIONS.......................................................................................................................................................................5

7.0ChLP condylar femoral plate .....................................................................................................................................................6

VI. CATALOGUE PAGES ............................................................................................................................. 6VI.1. PLATES ..............................................................................................................................................................................6

7.0ChLP condylar tibial plate ..........................................................................................................................................................87.0ChLP wide tibial plate ..............................................................................................................................................................107.0ChLP proximal lateral tibial plate .............................................................................................................................................127.0ChLP femoral proximal plate ...................................................................................................................................................147.0ChLP wide compression limited contact plate ........................................................................................................................157.0ChLP screw Ø5,0 ....................................................................................................................................................................167.0ChLP conical self-tapping screw .............................................................................................................................................16

VI.2. SCREWS...........................................................................................................................................................................16Cortical screw Ø4,5 ......................................................................................................................................................................177.0ChLP cerclage screws .............................................................................................................................................................177.0ChLP distance screw ...............................................................................................................................................................177.0ChLP screw hole insert ...........................................................................................................................................................177.0ChLP cannulated screw Ø7.3x16 ...........................................................................................................................................187.0ChLP cannulated screw Ø7.3 .................................................................................................................................................187.0ChLP conical cannulated screw Ø7.3x16 ...............................................................................................................................187.0ChLP conical cannulated screw Ø7.3 .....................................................................................................................................187.0ChLP cancellous screw Ø6.5 ..................................................................................................................................................197.0ChLP cancellous screw Ø5.4 ..................................................................................................................................................19Stand for screws 7.0ChLP ............................................................................................................................................................20

VI.3. INSTRUMENTS FOR 7.0ChLP PLATE ...........................................................................................................................21A. Universal instrument set 40.5702.700 .....................................................................................................................................21B. Additional instruments ..............................................................................................................................................................23

VII. SURGICAL TEChNIQUE .................................................................................................................... 24VII.1. TEMPORARY PLATE ATTAChMENT .............................................................................................................................24

VII.2. LOCKING SCREW Ø5.0 INSERTION .............................................................................................................................25

VII.3. ThE USE OF AIMING BLOCK ........................................................................................................................................28

VII.4. CORTICAL SCREW Ø4.5 INSERTION ...........................................................................................................................29

VII.5. LOCKING SCREW Ø7.3 INSERTION .............................................................................................................................31

VIII. POSTOPERATIVE TREATMENT ....................................................................................................... 32

IX. IMPLANT REMOVAL ........................................................................................................................... 32

X. INSTRUCTIONS FOR USE ................................................................................................................... 33



INTRODUCTION

The main purpose of surgical treatment of bone fractures is toreconstruct the anatomical bone structure and to restore its function.Internal stabilization with locking plates enables accuratefracture reduction, stable fixation, blood flow preservation andfunctional activation of injured limb.

System ChLP consists of titanium plates and screws combininglocking screws technique with conventional treatment techniquesusing plates. This system is the improvement of existingstabilization methods. Locking screws system enables angularfixation using conventional surgical techniques. It is particularlyindicated in:• multifragmental fractures;• non-unions or malunions;• osteopenia;• osteotomy stabilization;• when applying conventional screws is insufficient or does not• bring expected effects.

Locking plates are provided with holes A for conventional corticalscrews with or without compression and with threaded holes Bfor locking screws.Compression holes designed in ChLP System enable compres-sion in both directions.

Plates design allows to perform classical dynamic compression.

Advantages of using locking plates system over conventionalmethods of fracture treatment using plates:• enable stable fixation ensuring angular stabilization in fractu-

re site;• enable compression using conventional cortical and cancello-

us screws, combination with conventional and locking screws is available;

• reduced bone-plate contact ensures better blood fl ow of perim-plant tissues;

• locking screws enable uni-cortical plate position against thebone;

• plates can be contoured to match the anatomical bone sha-pethat is particular important in periarticular fractures.

Following instruction does not refer to particular fracture typesas the locking plates system includes different plates that arerelevant to many different fractures.

ChLP System was divided as follows:• 4.0ChLP System;• 4.5ChLP System;• 5.0ChLP System;• 7.0ChLP System.

Division is based on the screw head diameter however, screwswith different cortical thread diameter in one system range areavailable.

Additionally, systems were differentiated with colors as follows:• 4.0ChLP System – green;• 4.5ChLP System – gold;• 5.0ChLP System – brown;• 7.0ChLP System – blue.

Before product usage, read the Instructions For Use carefully. The IFU is supplied with the product and attached at the endof this document. It includes, among others: the indications, contraindications, adverse effects, warnings and recommenda-tions associated with product usage.

I. INTRODUCTION

A B



INTRODUCTION

Wide size range of locking plates enables proper plate selection.Locking plate contouring is not recommended due to possiblity of threaded holes damaging.Bottom surface of the plate does not have to contact the bone if locking screws are used. There is no necessity of accurate platescontouring. Advanced shaped plates do not require additional bending in most cases.

If the plate bending is necessary, remember not to deform threaded holes excessively. It is essential to ensure that the desired sha-pe of the implant is reached in as few bends as possible because titanium hardness increases and ductility (bendability) decreases. Excessive bending can lead to postoperative fracture of the plate. Due to potential risk for postoperative implant breakage, extremely acute angles together with small bending radii must be avoided. If Implant damages (indentations, elongated screw holes, etc.) occur, plate is to be exchanged for new one, more carefully bent one.

If the plate bending is required:• perform it between locking holes;• do not bend the plate more than 20° – 25°;• do not bend the plate back and forth;• before bending, insert the locking screws in the bending area, that decreases the threaded holes deformation degree.

II. PLATE SELECTION AND CONTOURING

V.1. INDICATIONS

7.0 locking plate system is designed to stabilize the fracture of various long bones such as:• femoral bone,• tibial bone

Straight wide plates are mainly used to stabilize the shafts of bone fractures. Shape plates are used for metaphysial bone fractures as well as simple, comminuted, wedge-shaped lateral and medial fractures, condylar fractures and the ones combined with the shaft of a bone.

6

L R

L

Titanium 3.1664.030÷1003.5221.030÷100

Ø7,3

Titanium 3.1448.016÷1103.5210.016÷110

Ø5,0

Titanium 3.1448.016÷1103.5210.016÷110

Ø5,0

Titanium 3.1443.016÷1103.1471.016÷110

Ø4,5

Titanium 3.1443.016÷1103.1471.016÷110

Ø4,5

Left

Catalogue no. O L [mm] TITANIUM 4 138 3.4023.6046 180 3.4023.6068 221 3.4023.60810 263 3.4023.61012 305 3.4023.61214 346 3.4023.61416 387 3.4023.616

Right

Catalogue no. O L [mm] TITANIUM 4 138 3.4024.6046 180 3.4024.6068 221 3.4024.60810 263 3.4024.61012 305 3.4024.61214 346 3.4024.61416 387 3.4024.616

O - holes number in shaft part of the plate

Palette for 7.0ChLP plates - 3.4023/3.4024

No. Catalogue no. Name Pcs

1 40.5725.100 Aiming block [3.4023] 1

40.5

704.

310

40.5

704.

5102 40.5725.200 Aiming block [3.4024] 1

3 40.5708.000 Protective guide 9.0/7.0 2

4 40.5704.410 Palette 1

5 12.0750.100 Container solid bottom 1/1 595x275x86mm 1

6 12.0750.200 Perforated aluminum lid1/1 595x275x15mm Gray 1

implants not included; with additional instruments

ChM Ltd., Lewickie 3b, 16-061 Juchnowiec K., POLANDtel. +48 85 713-13-20 ÷ 25 fax +48 85 713-13-19 e-mail: [email protected]

IMPLANTS

VI. CATALOGUE PAGESVI.1. PLATES

7.0ChLP condylar femoral plate



Indications

• Comminuted fractures of the distal part of the femoral bone and fractures extending to the shaft of the femur.• Supracondylar fractures.• Articular and extra-articular condylar fractures.• Non-union or malunions of fractured bone.

Contraindications

Absolute• Health condition precluding surgery.• Allergic reactions to the metal from which the implant is made.• Active infection.

Relative• Weakened bone (by disease, infection or prior implantation) making it impossible to install/stabilize the implant properly.• Abnormal perfusion of fracture area or surgical site.• Excessive obesity.• Lack of adequate tissue coverage.• Psychiatric disorders or the disorders of the musculoskeletal system which may create a risk of fusion failure or complications

in the postoperative period.• Other medical conditions that exclude the potential benefits of the treatment.

The patient’s position

Procedure stages

• Reduction of fracture and stabilization of the fracture fragments with Kirschner wires.• The choice of implants - determining the length and position of the implant.• Insertion of the plate and its positioning.• Temporary stabilization of the implant using Kirschner wires.• Introduction of the screws to the distal parts of the plate.• Stabilization of the shaft using locking or compression screws.

Surgical approach

LATERAL APPROACh: the lateral incision of about 80 mm in the proximal direction shall begin from Gerdy’s tubercle. If ne-cessary, the incision may be lengthened. The incision is recom-mended for extra-articular fractures and simple articular and me-taphysial fractures without displacement.

ANTERIOR-LATERAL APPROACh: perform the parapatellar in-cision. Perform the arthrotomy as to expose the articulation and reduce the fragments of the fractured bone; pull the patel-la medially and widen the cut adequately to expose the femo-ral condyle. The parapatellar incision is recommended for more complex articular comminuted fractures.

8

L

LR

Titanium 3.1448.016÷1103.5210.016÷110

Ø5,0

Titanium 3.1448.016÷1103.5210.016÷110

Ø5,0

Titanium 3.1443.016÷1103.1471.016÷110

Ø4,5

Left

Catalogue no. O L [mm] TITANIUM 4 129 3.4013.6045 150 3.4013.6056 171 3.4013.6068 213 3.4013.608

Right



available O L [mm]

4 ÷ 12 129 ÷ 297



1 40.5724.100 Aiming block [3.4013] 1

40.5

704.

320

40.5

704.

5202 40.5724.200 Aiming block [3.4014] 1


4 40.5704.420 Palette 1





IMPLANTS

7.0ChLP condylar tibial plate



Indications

• Articular and extra-articular, metaphysial and epiphysial comminuted fractures of the proximal part of the tibia and fractures extending to the shaft of the tibia.

• Non-union or malunions of fractured bone

Contraindications

Absolute:• Health condition precluding surgery.• Allergic reactions to the metal from which the implant is made.• Active infection.

Relative:• Weakened bone (by disease, infection or prior implantation) making it impossible to install/stabilize the implant properly.• Abnormal perfusion of fracture area.• Excessive obesity.• Lack of adequate tissue coverage.• Psychiatric disorders or the disorders of the musculoskeletal system which may create a risk of fusion failure or complications



Procedure stages

• Reduction of fracture and stabilization of the fracture fragments using Kirschner wires. • The choice of implants - determining the length and position of the implant.• Insertion of the plate and its positioning.• Temporary stabilization of the implant using Kirschner wires.• Introduction of the screws in the distal parts of the plate.• Stabilization of the shaft using locking or compression screws.• Positioning of the plate using the compression screw in the extended hole.• Making X-Ray film in both A-P and lateral position as to make sure the plate and screws are positioned properly.• Closing the wound.

Surgical approach

Lateral S incision - recommended for simple articular and extra--articular fractures

Straight anterior-lateral incision - recommended for more com-plex articular fractures.

Anterior-lateral approach. The incision performed between the tibia and fibula bone and should begin approximately 1 cm proximally from Ger-dy’s tubercle for a desired length of the plate. In the minimally invasive technique, a short cut and additional cuts for the access to the holes of the shaft of the plate should be performed.

10

Titanium 3.1448.016÷1103.5210.016÷110

Ø5,0

Titanium 3.1443.016÷1103.1471.016÷110

Ø4,5

LR

L

Titanium 3.1448.016÷1103.5210.016÷110

Ø5,0

Left


Right



available O L [mm]

4 ÷ 14 116 ÷ 326



1 40.5704.340 Palette 1

40.5

704.

540



implants not included


IMPLANTS

7.0ChLP wide tibial plate



Indications



Contraindications





Procedure stages


Surgical approach

Lateral S incision - recommended for simple articular and extra--articular fractures

Straight anterior-lateral incision - recommended for more com-plex articular fractures.


12

L

R L

Titanium 3.1448.016÷1103.5210.016÷110

Ø5,0

Titanium 3.1448.016÷1103.5210.016÷110

Ø5,0

Titanium 3.1443.016÷1103.1471.016÷110

Ø4,5



1 40.5709.100 Aiming block [3.4089] 1

40.5

704.

360

40.5

704.

5602 40.5709.200 Aiming block [3.4090] 1


4 40.5704.460 Palette 1




Left


Right



available O L [mm]

3 ÷ 10 131 ÷ 278


IMPLANTS

7.0ChLP proximal lateral tibial plate



Indications



Contraindications





Procedure stages


Surgical approach

Lateral S incision - recommended for simple articular and extra--articular fractures Straight anterior-lateral incision - recommended for more com-

plex articular fractures.


14

L

LR

Titanium 3.1448.016-110

Ø5,0

Titanium 3.1443.016-140

Ø4,5

Titanium 3.1448.016-110

Ø5,0

Titanium 3.1664.030-095

Ø7,3



1 40.5732.100 Aiming block [3.7023] 1

40.5

704.

390

40.5

704.

5902 40.5732.200 Aiming block [3.7022] 1


4 40.5704.490 Palette 1




Left

Catalogue no. O L [mm] TITANIUM 2 132 3.7023.6024 174 3.7023.604

6 216 3.7023.606

8 258 3.7023.608

10 300 3.7023.610

12 342 3.7023.612

14 384 3.7023.614

16 426 3.7023.616

Right

Catalogue no. O L [mm] TITANIUM 2 132 3.7022.602

4 174 3.7022.604

6 216 3.7022.606

8 258 3.7022.608

10 300 3.7022.610

12 342 3.7022.612

14 384 3.7022.614

16 426 3.7022.616



IMPLANTS

7.0ChLP femoral proximal plate

15

L

3.1448.016÷1103.5210.016÷110

Ø5,0

3.1443.016÷1103.1471.016÷110

Ø4,5

Catalogue no.

O L [mm] TITANIUM 4 89 3.3155.6046 131 3.3155.6068 173 3.3155.608

10 225 3.3155.61012 257 3.3155.61214 299 3.3155.61416 341 3.3155.61618 383 3.3155.618

O - all threaded holes number in the plate

Palette for 7.0ChLP plates - straight


1 40.5704.350 Palette 1

40.5

704.

550





IMPLANTS

7.0ChLP wide compression limited contact plate

16

L

Ø5,0

Ø7,0

samogwintującyself-tappingсамонарезающий


Ø7,0

Ø5,0

L

3,5 T25

Catalogue no.

L [mm] TITANIUM

30 3.1449.030 3.5216.03035 3.1449.035 3.5216.03540 3.1449.040 3.5216.04045 3.1449.045 3.5216.04550 3.1449.050 3.5216.05055 3.1449.055 3.5216.05560 3.1449.060 3.5216.06065 3.1449.065 3.5216.06570 3.1449.070 3.5216.07075 3.1449.075 3.5216.07580 3.1449.080 3.5216.08085 3.1449.085 3.5216.08590 3.1449.090 3.5216.090



Ø Core 4,.0

Ø Drill with scale 40.5651.222 4,.0

Guide sleeve 40.5705.740 7,.0/4,.0

Screwdriver tip 40.5686.000 S3,.5

Screwdriver tip 40.5684.000 T25

Tap 40.5646.000 5,.0

3,5 T25

Catalogue no.

L [mm] TITANIUM

16 3.1448.016 3.5210.01618 3.1448.018 3.5210.01820 3.1448.020 3.5210.02022 3.1448.022 3.5210.02224 3.1448.024 3.5210.02426 3.1448.026 3.5210.02628 3.1448.028 3.5210.02830 3.1448.030 3.5210.03032 3.1448.032 3.5210.03234 3.1448.034 3.5210.03436 3.1448.036 3.5210.03638 3.1448.038 3.5210.03840 3.1448.040 3.5210.04042 3.1448.042 3.5210.04244 3.1448.044 3.5210.04446 3.1448.046 3.5210.04648 3.1448.048 3.5210.04850 3.1448.050 3.5210.05052 3.1448.052 3.5210.05254 3.1448.054 3.5210.05456 3.1448.056 3.5210.05658 3.1448.058 3.5210.05860 3.1448.060 3.5210.06065 3.1448.065 3.5210.06570 3.1448.070 3.5210.07075 3.1448.075 3.5210.07580 3.1448.080 3.5210.08085 3.1448.085 3.5210.08590 3.1448.090 3.5210.09095 3.1448.095 3.5210.095100 3.1448.100 3.5210.100105 3.1448.105 3.5210.105110 3.1448.110 3.5210.110


IMPLANTS

VI.2. SCREWS

7.0ChLP screw Ø5,0 7.0ChLP conical self-tapping screw

17

Catalogue no.

TITANIUM

3.1221.070

L

Ø5,0

Ø7,0

Ø7,0

L

Ø4,5

4,6

Ø8,0


Ø Core 3,.0


Compression guide 40.4802.732 3,.2

Screwdriver tip 40.5686.000 S3,.5


Tap 40.5647.000 hA4,.5

3,5 T25

Catalogue no.

L [mm] TITANIUM

16 3.1443.016 3.1471.01618 3.1443.018 3.1471.01820 3.1443.020 3.1471.02022 3.1443.022 3.1471.02224 3.1443.024 3.1471.02426 3.1443.026 3.1471.02628 3.1443.028 3.1471.02830 3.1443.030 3.1471.03032 3.1443.032 3.1471.03234 3.1443.034 3.1471.03436 3.1443.036 3.1471.03638 3.1443.038 3.1471.03840 3.1443.040 3.1471.04042 3.1443.042 3.1471.04244 3.1443.044 3.1471.04446 3.1443.046 3.1471.04648 3.1443.048 3.1471.04850 3.1443.050 3.1471.05052 3.1443.052 3.1471.05254 3.1443.054 3.1471.05456 3.1443.056 3.1471.05658 3.1443.058 3.1471.05860 3.1443.060 3.1471.06062 3.1443.062 3.1471.06264 3.1443.064 3.1471.06466 3.1443.066 3.1471.06668 3.1443.068 3.1471.06870 3.1443.070 3.1471.07072 3.1443.072 3.1471.07274 3.1443.074 3.1471.07476 3.1443.076 3.1471.07678 3.1443.078 3.1471.07880 3.1443.080 3.1471.08085 3.1443.085 3.1471.08590 3.1443.090 3.1471.09095 3.1443.095 3.1471.095

100 3.1443.100 3.1471.100105 3.1443.105 3.1471.105110 3.1443.110 3.1471.110

Screwdriver 40.4746.000

3,5 T25

Catalogue no.

L [mm] TITANIUM

8 3.1448.008 3.5219.008

3,5 T25

Catalogue no.

L [mm] TITANIUM

8 3.1382.000 3.5220.000


IMPLANTS

7.0ChLP cerclage screwsCortical screw Ø4,5

7.0ChLP distance screw

7.0ChLP screw hole insert

18

16

samowiercącyself-drillingсамосверлящий

L

Ø7,3

Ø9,0


Ø2,2

5,0

Ø2,2

T30

Catalogue no.

L[mm] TITANIUM

30 3.1664.030 3.5221.03035 3.1664.035 3.5221.03540 3.1664.040 3.5221.04045 3.1664.045 3.5221.04550 3.1664.050 3.5221.05055 3.1664.055 3.5221.05560 3.1664.060 3.5221.06065 3.1664.065 3.5221.06570 3.1664.070 3.5221.07075 3.1664.075 3.5221.07580 3.1664.080 3.5221.08085 3.1664.085 3.5221.08590 3.1664.090 3.5221.09095 3.1664.095 3.5221.095

100 3.1664.100 3.5221.100

Ø2,2

5,0

Ø2,2

T30

Catalogue no.

L[mm] TITANIUM

30 3.1663.030 3.5222.03035 3.1663.035 3.5222.03540 3.1663.040 3.5222.04045 3.1663.045 3.5222.04550 3.1663.050 3.5222.05055 3.1663.055 3.5222.05560 3.1663.060 3.5222.06065 3.1663.065 3.5222.06570 3.1663.070 3.5222.07075 3.1663.075 3.5222.07580 3.1663.080 3.5222.08085 3.1663.085 3.5222.08590 3.1663.090 3.5222.09095 3.1663.095 3.5222.095100 3.1663.100 3.5222.100

L

Ø7,3

Ø9,0 Ø9,0

Ø9,0

16L

L

Ø7,3

Ø7,3


Ø2,2

5,0

Ø2,2

T30

Catalogue no.

L[mm] TITANIUM

30 3.1665.030 3.5224.03035 3.1665.035 3.5224.03540 3.1665.040 3.5224.04045 3.1665.045 3.5224.04550 3.1665.050 3.5224.05055 3.1665.055 3.5224.05560 3.1665.060 3.5224.06065 3.1665.065 3.5224.06570 3.1665.070 3.5224.07075 3.1665.075 3.5224.07580 3.1665.080 3.5224.08085 3.1665.085 3.5224.08590 3.1665.090 3.5224.09095 3.1665.095 3.5224.095

Ø2,2

5,0

Ø2,2

T30

Catalogue no.

L[mm] TITANIUM

30 3.1666.030 3.5223.03035 3.1666.035 3.5223.03540 3.1666.040 3.5223.04045 3.1666.045 3.5223.04550 3.1666.050 3.5223.05055 3.1666.055 3.5223.05560 3.1666.060 3.5223.06065 3.1666.065 3.5223.06570 3.1666.070 3.5223.07075 3.1666.075 3.5223.07580 3.1666.080 3.5223.08085 3.1666.085 3.5223.08590 3.1666.090 3.5223.09095 3.1666.095 3.5223.095

Ø Core 5,.2

Ø Kirschner wire 40.4815.220 2,.0

Guide sleeve 40.5654.120/150 5,.0/2,.0

Ø Drill with scale 40.5652.222 5,.0/2,.0

Guide sleeve 40.5654.150 5,.0

Screwdriver tip 40.5687.000 S5



IMPLANTS

7.0ChLP cannulated screw Ø7.3x16

7.0ChLP cannulated screw Ø7.3

7.0ChLP conical cannulated screw Ø7.3x16

7.0ChLP conical cannulated screw Ø7.3

19

L5,0 T30

Catalogue no.

L[mm] TITANIUM

30 3.1383.030 3.5228.03035 3.1383.035 3.5228.03540 3.1383.040 3.5228.04045 3.1383.045 3.5228.04550 3.1383.050 3.5228.05055 3.1383.055 3.5228.05560 3.1383.060 3.5228.06065 3.1383.065 3.5228.06570 3.1383.070 3.5228.07075 3.1383.075 3.5228.07580 3.1383.080 3.5228.08085 3.1383.085 3.5228.08590 3.1383.090 3.5228.09095 3.1383.095 3.5228.095

Ø9,0

Ø6,5


3,5 T25

Catalogue no.

L[mm] TITANIUM

30 3.1380.030 3.5232.03035 3.1380.035 3.5232.03540 3.1380.040 3.5232.04045 3.1380.045 3.5232.04550 3.1380.050 3.5232.05055 3.1380.055 3.5232.05560 3.1380.060 3.5232.06065 3.1380.065 3.5232.06570 3.1380.070 3.5232.07075 3.1380.075 3.5232.07580 3.1380.080 3.5232.08085 3.1380.085 3.5232.08590 3.1380.090 3.5232.090

L

Ø5,4

Ø7,0


Ø Core 3,.0


Guide sleeve 40.5707.732 3,.2

Screwdriver tip 40.5687.000 S5



IMPLANTS

7.0ChLP cancellous screw Ø6.5 7.0ChLP cancellous screw Ø5.4

20

40.5749.400


1 40.5749.400 Stand for screws 7.0ChLP 1

40.5

749.

500


3 12.0751.200Pokrywa aluminiowa perfor.SzaraPerforated aluminum lid1/2 306x272x15mm Gray

1



IMPLANTS

Stand for screws 7.0ChLP

21

No. Name Pcs Catalogue No.

1 Guide sleeve 7.0/2.0 2 40.5705.720

2 Guide sleeve 7.0/3.2 2 40.5705.732

3 Guide sleeve 7.0/4.0 4 40.5705.740

4 Compression guide 3.2 1 40.4802.732

5 Drill with scale 3.2/220 2 40.5650.222

6 Drill with scale 4.0/220 2 40.5651.222

7 Cannulated drill with scale 5.0/2.2/220 2 40.5652.222

8 Kirschner wire 2.0/220 4 40.4815.220

9 Setting-compressing screw 4.0/180 2 40.5706.740

10 Screw length measure 1 40.5675.100

11 Depth measure 1 40.4639.700

12 Screwdriver tip S3.5-1/4 1 40.5686.000

13 Screwdriver tip T 25-1/4 1 40.5684.000

14 Torque wrench 1 40.5270.400

15 Bender for plates 4/6 2 40.4250.000

16 Guide sleeve 9/3.2 1 40.5707.732

17 Guide sleeve 9/5.0 1 40.5654.750

18 Guide sleeve 5.0/2.0 1 40.5654.120

19 Cannulated screwdriver tip S5-1/4 1 40.5687.000

20 Cannulated screwdriver tip T30-1/4 1 40.5685.000

21 Star cannulated screwdriver T30 1 40.0672.000

22 Star screwdriver T25 1 40.0671.000

23 Hexagonal screwdriver S3.5 1 40.0320.000

24 Cannulated screwdriver S5 1 40.4817.000

25 Tap 7.0ChLP - 5.0 1 40.5646.000

26 Cortical tap HA 4.5 1 40.5647.000

27 Screwdriver 1 40.4746.000


INSTRUMENTS

VI.3. INSTRUMENTS FOR 7.0ChLP PLATE

A. Universal instrument set 40.5702.700

22


28

Stand for instrument set of 7.0ChLP plate 1 40.5703.700

Container with solid bottom 1/1 595x275x86mm 1 12.0750.100

Perforated aluminum lid 1/1 595x275x15mm gray 1 12.0750.200


INSTRUMENTS

23


1 Protective guide9.0/7.0 2 40.5708.000

2 Aiming block [3.4023] 1 40.5725.100

3 Aiming block[3.4024] 1 40.5725.200

4 Aiming block[3.4013] 1 40.5724.100

5 Aiming block[3.4014] 1 40.5724.200

6 Aiming block [3.4089] 1 40.5709.100

7 Aiming block[3.4090] 1 40.5709.200

8 Aiming block[3.7023] 1 40.5732.100

9 Aiming block[3.7022] 1 40.5732.200


INSTRUMENTS

B. Additional instrumentsInstruments not included in the instrument set [40.5702.700]

24

40.4815.22040.4815.220

40.5706.740

40.5705.740


SURGICAL TECHNIQUE

The above description is not detailed instruction of conduct. The surgeon decides about choosing the operating procedure.

When fracture is reduced and the plate position is confirmed, determineits temporary location using Kirschner wires 2.0 [40.4815.220].Wires can be inserted in proximal holes of the plate and the mostdistal ones.

Confirm the plate position is correct taking X-Ray image.

NOTE: The Setting-compressing screw 4.0/180 [40.5706.740] can be used to stabilize and tighten the plateup to the bone for temporary purposes. The screw is to be inserted via the Guide sleeve 7.0/4.0 [40.5705.740].

Locking screw Ø5.0 can be inserted in the hole after removal of the Setting-compressing screw 4.0/180.

Insert self drilling pin of setting-compres-sing screw.

Tightening the sleeve, pull the plateto the bone.

VII. SURGICAL TEChNIQUE

VII.1. TEMPORARY PLATE ATTAChMENT

25

40.5705.740


SURGICAL TECHNIQUE


VII.1. TEMPORARY PLATE ATTAChMENT

Guide sleeve screwing

Insert the Guide sleeve 7.0/4.0 [40.5705.740] into the plate

Drilling the hole

Ream the hole using the Drill with scale 4.0/220 [40.5651.222] until the desire depth is reached

hole depth measurement

OPTION I: Read the value on the Drill with scale [40.5651.222] or

VII.2. LOCKING SCREW Ø5.0 INSERTION

It is important to drill exactly in the axis of a locking hole. Use always the appropriate guide sleeve when drilling. The guide sleeve will ensure the locking screw take an axial position towards the hole of the plate and be correctly locked in the plate. Unprepared dril-ling of a hole can lead to: thread skewing and jamming the screw, incorrect screw locking and problems when removing the screws (thread seizure).



SURGICAL TECHNIQUE


OPTION II: use the Screw length measure [40.5675.100].

OPTION III: Unscrew the Guide sleeve 7.0/4.0 [40.5705.740] and define the screw length using the Depth mea-sure [40.4639.700].



SURGICAL TECHNIQUE


Screw insertion

Remove the Guide sleeve 7.0/4.0 [40.5705.740].

Insert the locking screw Ø5.0 using the Torque wrench [40.5270.400] and proper screwdriver tip.



SURGICAL TECHNIQUE


VII.3. ThE USE OF AIMING BLOCK

Most locking plates ChLP are available with aiming blocks, as additional complementary instruments. Using aiming blocks ensures proper fastening of gu-ide sleeves in the locking holes, in the epiphyseal part of the plate. It facilitates also the smooth conduct of the procedure, reduces its duration, and ensures that drilling is performed in the axis of the locking hole (note from point IV.2).

When aiming blocks are not used, the implantation can be incorrect, and in particular can casue:

• improper locking of the screws and their migration,• decrease of the fixation stability,• complications while implants removing.

Position the aiming block on the plate.

Tighten up with Star screwdriver T25 [40.0671.000].

Insert Protective sleeve 9.0/7.0 [40.5708.000] in the desired hole of the aiming block.

Then screw the Guide sleeve 7.0/4.0 [40.5705.740] into the plate through the Protective sleeve 9.0/7.0.

NOTE! Further proceedings in accordance with the steps de-scribed in the point IV.2 on page 25

40.0671.000

40.5705.740

40.5708.000



SURGICAL TECHNIQUE


Compression guide setting

Set the Compression guide 3.2 [40.4802.732] in desire position:

1. Neutral position Press the guide to the plate to achieve the neu-tral position for screw insertion

VII.4. CORTICAL SCREW Ø4.5 INSERTION

2. Compressive position

Move the guide without pressure to the edge of compression hole to achieve the compression position for screw insertion.

3. Angular position

Angular positioning of the guide is also available



SURGICAL TECHNIQUE


Screw insertion

Insert cortical screw Ø4.5


Insert the Depth neasure [40.4639.700] into the drilled hole until its hook anchors the outer surface of the opposite cortex

Drilling

Drill the hole through both cortices in desire position for the corticalscrew Ø4.5 insertion using the Drill Ø3.2/220 [40.5650.222]

31

* **


SURGICAL TECHNIQUE


In the middle of the condylar part of the femoral plate L-[3.4023], R-[3.4024], there is provided a larger hole for insertion of cannu-lated screw Ø7.3mm [3.1664.xxx].

Guide sleeve screwing

Screw in the Guide sleeve 9.0/5.0 [40.5654.750] along with the Guide sleeve 5.0/2.0 [40.5654.120] for Kirschner wire 2.0 insertion [40.4815.220].

VII.5. LOCKING SCREW Ø7.3 INSERTION


Insert Kirschner wire 2.0 [40.4815.220]; determine the screw length using the Screw length measure [40.5675.100].

Locking screw Ø7.3 insertion

Remove the Guide sleeve.Insert the Locking screw Ø7.3 using the Torque wrench [40.5270.400] and relevant cannulated screwdriver tip.

NOTE:

* Remove the Inner sleeve 5.0/2.0 [40.5654.120] and read the value using the Screw length me-asure [40.5675.100].

** Subtract 5mm from the measured value if the sleeve 5.0/2.0 [40.5654.120] is not removed



SURGICAL TECHNIQUE


NOTE:

Use the Cannulated drill with scale 5.0/2.2/220 [40.5652.222]

If the bone is very hard, use the Cannulated drill with scale 5,0/2,2/220 [40.5652.222]. Drill using the Guide sleeve 9.0/5.0 [40.5654.750] that was used for Kirchner wire 2.0 [40.4815.220] insertion.

Postoperative treatment after locking plates does not differ from treatment after conventional stabilization.

VIII. POSTOPERATIVE TREATMENT

IX. IMPLANT REMOVAL

In order to remove the screws, first unlock all locking screws from the plate. Then remove bone screws. This prevents the rotation of the platewhile removing the last locking screw.

Manufacturer: ChM Sp. z o.o.Lewickie 3b, 16-061 Juchnowiec K., Polandtel.: +48 85 713-13-20 fax: +48 85 713-13-19e-mail: [email protected] www.chm.eu

0197

ISO 9001/ ISO 13485

IFU-010/13

INSTRUCTIONS FOR USEImportant product information for

LOCKING PLATES AND SCREWS

STERILE R

NON

STERILE

PURPOSE AND INDICATIONSLocking Plates Systems are intended for surgical treatment of diaphysis and epiphysis

fractures and for arthrodesis. Indications for implantation:

-comminuted fracture, - transverse fracture, -spiral fracture, -compression fractures, -delayed union of fractures.

Lockingd Plates are to be implanted with speci� ed screws which are listed in ChM Ltd Product Catalogue.

ChM Ltd does not recommend any speci� c treatment method for particular pa-tient. CONTRAINDICATIONS

• Infection or in� ammation in the operative site.• Suspected or documented allergy or intolerance to implant materials. When material

sensitivity is suspected, testing is to be completed before implant insertion. • Blood supply limitation in fracture site or in operative site. • Any patient having inadequate tissue coverage of the operative site.• Insu� cient bone quality (caused by illness, infection or prior implantation) not providing

proper implant mounting/stabilization.• Morbid obesity (according to the W.H.O. standards) – would cause implant or � xation

failure. • Neuromuscular disorder which would create unacceptable risk of � xation failure or com-

plications in postoperative care.• Any other condition which would preclude the potential bene� t of implant usage

and disturb the normal process of bone remodeling, e.g. the presence of tumors or con-genital abnormalities, elevated ESR or high CRP unexplained by other diseases, eleva-tion of white blood count (WBC), or a marked left shift in the WBC di� erential count.

• Any patient unwilling to cooperate with postoperative instructions; mental illness, a con-dition of senility or substance abuse may cause the patient to ignore certain necessary limitations and precautions in the implant usage.

• Patients with a known hereditary or acquired bone friability or calci� cation problem should not be considered for this type of surgery.

• Any case where the implant components selected for use would be too large or too small to achieve a successful result.

• Any situation in which the implant usage would interfere with the anatomical structures or physiological performance.

• Any situation in which the implant usage should be considered (e.g. pregnancy).• Any other medical conditions which exclude the potential bene� ts of surgery.• Situation which acc. to the physician assessment there is any contraindication for metal

implant � xation.The above list is not exhaustive.

ADVERSE EFFECTSThe adverse e� ects may necessitate reoperation or revision. The surgeon

should warn the patient about possibility of adverse e� ects occurrence.Potential adverse events include but are not limited to:

• Infection and other adverse in� ammatory reactions. • Late bone fusion, non union or pseudoarthrosis. • Loss of anatomic position with nonunion or abnormal adhesion of bone with rotation

or angle change. • Implant loosening, bending, breaking.• Loss of stability due to non-union, osteoporosis or instable complex fractures.• Implant migration.• Implant compressing the surrounding tissue or organs.• Reaction to implants as foreign bodies, e.g. the possibility of tumor metaplasia, develop-

ing autoimmune disease and/or scarring.• Loss of proper curvature and length of bone.• Bone fractures or “stress shielding” phenomenon causing loss of bone above, below

or at the operative site. • Haemorrhage of blood vessels and / or hematomas.• Deep vein thrombosis, thrombophlebitis or pulmonary embolism.• Complications in donor site area.• Early or late loosening, or displacement of the implant.• Scar formation that could cause neurological impairment, or nerves compression

and/or pain.• Respiratory complications such as pulmonary embolism, atelectasis, bronchitis, pneu-

monia, etc.• Mental condition changes.• Limitations of the normal, everyday activities.

• Death.WARNINGS

The important medical information given in this document should be conveyed to the patient.

The selection of proper shape and size of the implant for each patient is cru-cial to the success of the surgery. The surgeon is responsible for selecting proper size. Preoperative and operating procedures, including knowledge of surgical techniques, proper fracture reduction, and correct selection and placement of the implants are im-portant and shall be considered by surgeon in order to achieve the successful utiliza-tion of the system.

A successful result is not always achieved in every surgical case. This principle applies especially to cases where other factors related to the patient’s condition may prevent from achieving desired results.

Moreover, it is crucial to the success of the surgery if patient follows instruction given by physician. Patients who smoke have been shown to have a reduced incidence of bone fusion. These patients should be adequately advised of this fact and warned of this con-sequence.

The implants are intended as a guide to healing process and are NOT intended to re-place normal body structure or bear the weight of the body. In such event or in case of delayed union or nonunion in the load or weight bearing might eventually cause the implant bending, loosening, disassembling or fatigue breaking.

No implant can withstand body loads without the support of bone. All metal surgical implants are subjected to repeated stresses, which can result in ma-

terial fatigue and failure of the implant. The surgeon should inform the patient that the device cannot and does not restore � exibility, strength, reliability and durability of normal, healthy bones.

Overweight may cause in implant additional stresses and strains which can lead to fa-tigue and deformation or in consequence failure of the implant.

The implant may break or become damaged as a result of strenuous activity or trau-ma, and the device may need to be replaced. To avoid excessive stress on the implant, which could lead to non-union or implant failure and clinical problems, the surgeon shall instruct the patient about the physical activity limitations during the formation and maturation of bony mass.

If the patient is involved in an occupation or activity which applies inordinate stress upon the implant (e.g. substantial walking, running, lifting, or muscle strain) the surgeon must advice the patient that resultant forces can cause implant failure.

It is essential to ensure that the desired shape of the implant is reached in as few bends as possible because titanium hardness increases and ductility (bendability) de-creases. Excessive bending can lead to postoperative fracture of the plate. Due to poten-tial risk for postoperative implant breakage, extremely acute angles together with small bending radii must be avoided. If Implant damages (indentations, elongated screw holes, etc.) occur, plate is to be exchanged for new one, more carefully bent one. Elongated screw holes do not provide accurate � t of the screw head to the plate. Plate segments must not be implanted into other patient.

While inserting the screw, it is essential to set correctly the screwdriver. Screwdriver should be set in the screw axis and proper axial pressure shall be applied to ensure the screwdriver recessing in the head of the bone screw as possible. Sensitive tightening of the screw must be exercised in the case of nonlocking screws without using a torque wrench. Given instruction reduces the risk of mechanical damage to the screw, screw-driver, or bony hole.PRODUCT DESCRIPTION1. Additional identi� cation system for the plates and screws has been introduced.

On the surfaces of steel and titanium plates additional feature „System e.g. 4.0, 4.5, 5.0, 7.0.” has been placed. Additional information help to state that particular screw (head diameter 4.0, 4.5, 5.0, 7.0.) cooperates with particular plate. Additionally, plate and screws included in the system, made of titanium, are color coded: System 4.0 - green, System 4.5 - gold, System 5.0 – brown, System 7.0 - blue.

2. Implants are single-use devices, provided sterile or non-sterile. 3. Not labeled implants are non-sterile.4. Package of each components should be intact at the time of receipt.5. The unit package contains:

a) Sterile device one piece of the product in sterile condition.b) Non-sterile device one piece of the product. Clear plastic bags are typical packag-

ing material. 6. A sterile indicator is put on the sterile package.7. The packaging is equipped with the product label. The label (as primary label) contains:

a) Sterile product: - ChM logo and address of manufacturer; trade-mark: ChLP system, - name and size of the product, - batch code (LOT), for example, „0900000”, - STERILE sign: indicates sterilized product, - Sterilization batch number S-1234567, - expiration date and sterilization method, - catalogue number (REF), e.g. „3.4034.503” (� rst digit indicates the material type e.g. 1 .4034.503 /1 -implantable steel/, 3 .4034.503 /3 -titanium/).

b) Non-Sterile product: - ChM logo and address of manufacturer; trade-mark: ChLP system, - name and size of the product, - batch code (LOT), for example, „0900000”, - NON-STERILE sign: indicates non-sterilized product, - catalogue number (REF), e.g. „3.4034.503” (� rst digit indicates the material type e.g. 1 .4034.503 /1 - implantable steel/, 3 .4034.503 /3 -titanium/).

8. In addition to the product primary label, on the unit package may also be placed an aux-iliary label, containing speci� c requirements of a speci� c area of the market (e.g legal requirements of the country in which the product will be distributed).

9. Additionally the package contains: instruction for use and labels placed in a pa-tient’s medical record.

10. Depending on the size or type of plate, the following information may be marked on its surface:

-manufacturer’s logo: ChM, -system „System 4.0, 4.5, 5.0, 7.0” (see paragraph 1. PRODUCT DESCRIPTION), -production batch no. (LOT), e.g. „1000000”, -catalogue number (REF), e.g.„1.3155.506” (� rst digit indicates the material type e.g. 1 .4034.503 /1 - implantable steel/, 3 .4034.503 /3 -titanium/), - type of material is indicated: S – implantable steel, T – titanium, -number of holes e.g. „6 holes”.

11. Depending on the size or type of screw, the following information may be marked on its surface:

-manufacturer’s logo: ChM, -production batch no. (LOT), e.g. „1000000”, -catalogue number (REF), e.g. „1.3155.506” (� rst digit indicates the material type e.g. 1 .3155.506 /1 -steel/, 3 .3155.506 /3 -titanium/), - type of material is indicated: S – steel, T – titanium.

• Only screws produced by ChM Ltd. (marked ChM) shall be used to lock the plate. Surgeon takes responsibility for using screws produced by other companies.

• Bending the plates in order to match the bone anatomy can be performed only with aid of instruments intended for this purpose.

• Only instruments produced by ChM ltd. shall be use for insertion and removal of ChM implants. Inraoperative fracture or breaking of instruments has been occasionally re-ported. Instruments, which have experienced extensive use or excessive force, are sus-ceptible to fracture. ChM Ltd. recommends that all instruments be regularly inspected for wear and dis� gurement.

PRODUCT MATERIAL -plates and screws made of implantable steel according to ISO 5832/1, 5832/9 stan-dards.

Alloy (content in %) – max valuesCr Ni Cu Mo C Si

22,0 15,0 0,5 3,0 0,08 1,0Mn P S N Nb Fe4,25 0,025 0,01 0,5 0,8 rest

-plates made of titanium according to 5832/2 standard. Chemicall (content in %) – max values

N C H Fe O Ti0,05 0,10 0,0125 0,40 0,40 rest

-screws made of titanium alloy according to 5832/3, 5832/11 standards.Alloy (content in %) – max values

Al Fe C N O6,75 0,3 0,08 0,05 0.2

H V Nb Ta Ti0,015 4,5 7,5 0,5 rest

Implantable titanium, titanium alloy and/or implantable cobalt alloy may be used together in the same construct.

Never use titanium, titanium alloy and/or cobalt alloy with stainless steel compo-nents in the same construct.

The type of the material is marked on the label of the device and on the device.Magnetic Resonance compatibility:

• for implants made of steel it is prohibited to carry out magnetic resonance imaging (MRI),

• implants made of titanium, titanium alloys and cobalt alloys are conditionally com-patible with magnetic resonance imaging. A patient can be scanned safely under the following conditions:

- static magnetic � eld of ≤ 3 Tesla, - maximum spatial gradient magnetic � eld of ≤ 720 Gauss/cm, - maximum MR system reported whole-body-averaged speci� c absorption rate (SAR) of 3W/kg for 15 minutes of scanning.

However, the user should be absolutely familiar with the contraindications and warnings established by manufacturer of the MRI scanner.

MR imaging may be interfered if the area of interest is in the exact same area or rela-tively close to the position of the implant.PRE-OPERATIVE RECOMMENDATION1. Only patients that meet the criteria described in the INDICATIONS should be selected.2. Patient conditions and/or predispositions such as those addressed in the aforemen-

tioned contraindications should be avoided.3. Before deciding about implantation, the surgeon shall inform the patient about indica-

tions and contraindications of such procedure and possibility of complications after the operations. Patient shall be introduced to the purpose and manner of procedure, and to functional and esthetic e� ects of such treatment. Proper clinical diagnosis and accurate operation planning and performance, are needed to achieve a good � -nal result of treatment.

4. Each implant shall be stored in separate protective package. The package shall not be opened until starting procedure.

5. Do not use the implant if the sterile packaging is intact. Sterility cannot be guaranteed if package is intact. The package shall be carefully verify before using.

6. The implantation shall be carried out by the surgeon familiar and experienced with ad-equate operating techniques and having undergone the necessary speci� c training in use of instruments produced by ChM Ltd. Surgical technique adequate for speci� c patient shall be chosen by surgeon.

7. The operation procedure shall be carefully planned. The size of implant should be deter-mined prior to beginning the surgery. An adequate inventory of implant sizes should be available at the time of surgery, including sizes larger and smaller than those ex-pected to be used.

8. Unless supplied sterile, all implants should be cleaned and sterilized before use. Additional sterile components should be available in case of any unexpected need. Before surgery, the surgeon should ascertain that all implants and instruments are sterilized.

9. Before procedure, all components including instruments should be carefully checked to ensure that there is no damage on implant surface. Any damaged implant (surface damages, shape deformations) shall not be used.

10. The surgeon should be familiar with each element before using and should personally verify all needed devices before the surgery.

11. Where material sensitivity is suspected, appropriate tests should be made prior to ma-terial selection or implantation. Alloying elements of implant material, are presented in section IMPLANT MATERIAL.

RECOMMENDATIONS FOR IMPLANT PROVIDED STERILE Sterile implant - is delivered in sterile package, with the inscription: “STERILE”. Such

product is sterile and the manufacturer is responsible for the process of sterilization. Products have been exposed to a minimum of 25kGy of gamma radiation process.

Before using of the sterile product, the following rules must be applied:a) Check out the expiration date of sterilization.

Do not use the devices with overstepped sterility date.b) Check out if the sterile package is not opened and damaged.

Do not use the devices if sterile package is intact.c) Check out if sterility indicator on the sterile packaging is red, which indicates that ra-

diation sterilization of the product was performed.Do not use devices when the sterility indicator is other than red.

RECOMMENDATIONS FOR IMPLANTS PROVIDED NON-STERILEBefore using of the non-sterile product, the following rules must be applied:The device must undergo cleaning, disinfecting and sterilization procedures. It is rec-

ommended to use an automated procedure (washer-disinfector) for cleaning and dis-infecting.

Implant cannot be sterilized in the package, in which was delivered. Patient’s labels shall be protected from loss or destruction during process of clean-

ing and sterilization. These rules of cleaning and sterilization should be followed for all devices planned

to be inserted. Instruments used for implantation shall undergone cleaning and ster-

X. INSTRUCTIONS FOR USE



INSTRUCTIONS FOR USE

Manufacturer: ChM Sp. z o.o.Lewickie 3b, 16-061 Juchnowiec K., Polandtel.: +48 85 713-13-20 fax: +48 85 713-13-19e-mail: [email protected] www.chm.eu

0197

ISO 9001/ ISO 13485

IFU-010/13

INSTRUCTIONS FOR USEImportant product information for

LOCKING PLATES AND SCREWS

STERILE R

NON

STERILE

PURPOSE AND INDICATIONSLocking Plates Systems are intended for surgical treatment of diaphysis and epiphysis

fractures and for arthrodesis. Indications for implantation:

-comminuted fracture, - transverse fracture, -spiral fracture, -compression fractures, -delayed union of fractures.

Lockingd Plates are to be implanted with speci� ed screws which are listed in ChM Ltd Product Catalogue.

ChM Ltd does not recommend any speci� c treatment method for particular pa-tient. CONTRAINDICATIONS

• Infection or in� ammation in the operative site.• Suspected or documented allergy or intolerance to implant materials. When material

sensitivity is suspected, testing is to be completed before implant insertion. • Blood supply limitation in fracture site or in operative site. • Any patient having inadequate tissue coverage of the operative site.• Insu� cient bone quality (caused by illness, infection or prior implantation) not providing

proper implant mounting/stabilization.• Morbid obesity (according to the W.H.O. standards) – would cause implant or � xation

failure. • Neuromuscular disorder which would create unacceptable risk of � xation failure or com-

plications in postoperative care.• Any other condition which would preclude the potential bene� t of implant usage

and disturb the normal process of bone remodeling, e.g. the presence of tumors or con-genital abnormalities, elevated ESR or high CRP unexplained by other diseases, eleva-tion of white blood count (WBC), or a marked left shift in the WBC di� erential count.

• Any patient unwilling to cooperate with postoperative instructions; mental illness, a con-dition of senility or substance abuse may cause the patient to ignore certain necessary limitations and precautions in the implant usage.

• Patients with a known hereditary or acquired bone friability or calci� cation problem should not be considered for this type of surgery.

• Any case where the implant components selected for use would be too large or too small to achieve a successful result.

• Any situation in which the implant usage would interfere with the anatomical structures or physiological performance.

• Any situation in which the implant usage should be considered (e.g. pregnancy).• Any other medical conditions which exclude the potential bene� ts of surgery.• Situation which acc. to the physician assessment there is any contraindication for metal

implant � xation.The above list is not exhaustive.

ADVERSE EFFECTSThe adverse e� ects may necessitate reoperation or revision. The surgeon

should warn the patient about possibility of adverse e� ects occurrence.Potential adverse events include but are not limited to:

• Infection and other adverse in� ammatory reactions. • Late bone fusion, non union or pseudoarthrosis. • Loss of anatomic position with nonunion or abnormal adhesion of bone with rotation

or angle change. • Implant loosening, bending, breaking.• Loss of stability due to non-union, osteoporosis or instable complex fractures.• Implant migration.• Implant compressing the surrounding tissue or organs.• Reaction to implants as foreign bodies, e.g. the possibility of tumor metaplasia, develop-

ing autoimmune disease and/or scarring.• Loss of proper curvature and length of bone.• Bone fractures or “stress shielding” phenomenon causing loss of bone above, below

or at the operative site. • Haemorrhage of blood vessels and / or hematomas.• Deep vein thrombosis, thrombophlebitis or pulmonary embolism.• Complications in donor site area.• Early or late loosening, or displacement of the implant.• Scar formation that could cause neurological impairment, or nerves compression

and/or pain.• Respiratory complications such as pulmonary embolism, atelectasis, bronchitis, pneu-

monia, etc.• Mental condition changes.• Limitations of the normal, everyday activities.

• Death.WARNINGS

The important medical information given in this document should be conveyed to the patient.

The selection of proper shape and size of the implant for each patient is cru-cial to the success of the surgery. The surgeon is responsible for selecting proper size. Preoperative and operating procedures, including knowledge of surgical techniques, proper fracture reduction, and correct selection and placement of the implants are im-portant and shall be considered by surgeon in order to achieve the successful utiliza-tion of the system.

A successful result is not always achieved in every surgical case. This principle applies especially to cases where other factors related to the patient’s condition may prevent from achieving desired results.

Moreover, it is crucial to the success of the surgery if patient follows instruction given by physician. Patients who smoke have been shown to have a reduced incidence of bone fusion. These patients should be adequately advised of this fact and warned of this con-sequence.

The implants are intended as a guide to healing process and are NOT intended to re-place normal body structure or bear the weight of the body. In such event or in case of delayed union or nonunion in the load or weight bearing might eventually cause the implant bending, loosening, disassembling or fatigue breaking.

No implant can withstand body loads without the support of bone. All metal surgical implants are subjected to repeated stresses, which can result in ma-

terial fatigue and failure of the implant. The surgeon should inform the patient that the device cannot and does not restore � exibility, strength, reliability and durability of normal, healthy bones.

Overweight may cause in implant additional stresses and strains which can lead to fa-tigue and deformation or in consequence failure of the implant.

The implant may break or become damaged as a result of strenuous activity or trau-ma, and the device may need to be replaced. To avoid excessive stress on the implant, which could lead to non-union or implant failure and clinical problems, the surgeon shall instruct the patient about the physical activity limitations during the formation and maturation of bony mass.

If the patient is involved in an occupation or activity which applies inordinate stress upon the implant (e.g. substantial walking, running, lifting, or muscle strain) the surgeon must advice the patient that resultant forces can cause implant failure.

It is essential to ensure that the desired shape of the implant is reached in as few bends as possible because titanium hardness increases and ductility (bendability) de-creases. Excessive bending can lead to postoperative fracture of the plate. Due to poten-tial risk for postoperative implant breakage, extremely acute angles together with small bending radii must be avoided. If Implant damages (indentations, elongated screw holes, etc.) occur, plate is to be exchanged for new one, more carefully bent one. Elongated screw holes do not provide accurate � t of the screw head to the plate. Plate segments must not be implanted into other patient.

While inserting the screw, it is essential to set correctly the screwdriver. Screwdriver should be set in the screw axis and proper axial pressure shall be applied to ensure the screwdriver recessing in the head of the bone screw as possible. Sensitive tightening of the screw must be exercised in the case of nonlocking screws without using a torque wrench. Given instruction reduces the risk of mechanical damage to the screw, screw-driver, or bony hole.PRODUCT DESCRIPTION1. Additional identi� cation system for the plates and screws has been introduced.

On the surfaces of steel and titanium plates additional feature „System e.g. 4.0, 4.5, 5.0, 7.0.” has been placed. Additional information help to state that particular screw (head diameter 4.0, 4.5, 5.0, 7.0.) cooperates with particular plate. Additionally, plate and screws included in the system, made of titanium, are color coded: System 4.0 - green, System 4.5 - gold, System 5.0 – brown, System 7.0 - blue.

2. Implants are single-use devices, provided sterile or non-sterile. 3. Not labeled implants are non-sterile.4. Package of each components should be intact at the time of receipt.5. The unit package contains:

a) Sterile device one piece of the product in sterile condition.b) Non-sterile device one piece of the product. Clear plastic bags are typical packag-

ing material. 6. A sterile indicator is put on the sterile package.7. The packaging is equipped with the product label. The label (as primary label) contains:

a) Sterile product: - ChM logo and address of manufacturer; trade-mark: ChLP system, - name and size of the product, - batch code (LOT), for example, „0900000”, - STERILE sign: indicates sterilized product, - Sterilization batch number S-1234567, - expiration date and sterilization method, - catalogue number (REF), e.g. „3.4034.503” (� rst digit indicates the material type e.g. 1 .4034.503 /1 -implantable steel/, 3 .4034.503 /3 -titanium/).

b) Non-Sterile product: - ChM logo and address of manufacturer; trade-mark: ChLP system, - name and size of the product, - batch code (LOT), for example, „0900000”, - NON-STERILE sign: indicates non-sterilized product, - catalogue number (REF), e.g. „3.4034.503” (� rst digit indicates the material type e.g. 1 .4034.503 /1 - implantable steel/, 3 .4034.503 /3 -titanium/).

8. In addition to the product primary label, on the unit package may also be placed an aux-iliary label, containing speci� c requirements of a speci� c area of the market (e.g legal requirements of the country in which the product will be distributed).

9. Additionally the package contains: instruction for use and labels placed in a pa-tient’s medical record.

10. Depending on the size or type of plate, the following information may be marked on its surface:

-manufacturer’s logo: ChM, -system „System 4.0, 4.5, 5.0, 7.0” (see paragraph 1. PRODUCT DESCRIPTION), -production batch no. (LOT), e.g. „1000000”, -catalogue number (REF), e.g.„1.3155.506” (� rst digit indicates the material type e.g. 1 .4034.503 /1 - implantable steel/, 3 .4034.503 /3 -titanium/), - type of material is indicated: S – implantable steel, T – titanium, -number of holes e.g. „6 holes”.

11. Depending on the size or type of screw, the following information may be marked on its surface:

-manufacturer’s logo: ChM, -production batch no. (LOT), e.g. „1000000”, -catalogue number (REF), e.g. „1.3155.506” (� rst digit indicates the material type e.g. 1 .3155.506 /1 -steel/, 3 .3155.506 /3 -titanium/), - type of material is indicated: S – steel, T – titanium.

• Only screws produced by ChM Ltd. (marked ChM) shall be used to lock the plate. Surgeon takes responsibility for using screws produced by other companies.

• Bending the plates in order to match the bone anatomy can be performed only with aid of instruments intended for this purpose.

• Only instruments produced by ChM ltd. shall be use for insertion and removal of ChM implants. Inraoperative fracture or breaking of instruments has been occasionally re-ported. Instruments, which have experienced extensive use or excessive force, are sus-ceptible to fracture. ChM Ltd. recommends that all instruments be regularly inspected for wear and dis� gurement.

PRODUCT MATERIAL -plates and screws made of implantable steel according to ISO 5832/1, 5832/9 stan-dards.

Alloy (content in %) – max valuesCr Ni Cu Mo C Si

22,0 15,0 0,5 3,0 0,08 1,0Mn P S N Nb Fe4,25 0,025 0,01 0,5 0,8 rest

-plates made of titanium according to 5832/2 standard. Chemicall (content in %) – max values

N C H Fe O Ti0,05 0,10 0,0125 0,40 0,40 rest

-screws made of titanium alloy according to 5832/3, 5832/11 standards.Alloy (content in %) – max values

Al Fe C N O6,75 0,3 0,08 0,05 0.2

H V Nb Ta Ti0,015 4,5 7,5 0,5 rest

Implantable titanium, titanium alloy and/or implantable cobalt alloy may be used together in the same construct.

Never use titanium, titanium alloy and/or cobalt alloy with stainless steel compo-nents in the same construct.

The type of the material is marked on the label of the device and on the device.Magnetic Resonance compatibility:

• for implants made of steel it is prohibited to carry out magnetic resonance imaging (MRI),

• implants made of titanium, titanium alloys and cobalt alloys are conditionally com-patible with magnetic resonance imaging. A patient can be scanned safely under the following conditions:

- static magnetic � eld of ≤ 3 Tesla, - maximum spatial gradient magnetic � eld of ≤ 720 Gauss/cm, - maximum MR system reported whole-body-averaged speci� c absorption rate (SAR) of 3W/kg for 15 minutes of scanning.

However, the user should be absolutely familiar with the contraindications and warnings established by manufacturer of the MRI scanner.

MR imaging may be interfered if the area of interest is in the exact same area or rela-tively close to the position of the implant.PRE-OPERATIVE RECOMMENDATION1. Only patients that meet the criteria described in the INDICATIONS should be selected.2. Patient conditions and/or predispositions such as those addressed in the aforemen-

tioned contraindications should be avoided.3. Before deciding about implantation, the surgeon shall inform the patient about indica-

tions and contraindications of such procedure and possibility of complications after the operations. Patient shall be introduced to the purpose and manner of procedure, and to functional and esthetic e� ects of such treatment. Proper clinical diagnosis and accurate operation planning and performance, are needed to achieve a good � -nal result of treatment.

4. Each implant shall be stored in separate protective package. The package shall not be opened until starting procedure.

5. Do not use the implant if the sterile packaging is intact. Sterility cannot be guaranteed if package is intact. The package shall be carefully verify before using.

6. The implantation shall be carried out by the surgeon familiar and experienced with ad-equate operating techniques and having undergone the necessary speci� c training in use of instruments produced by ChM Ltd. Surgical technique adequate for speci� c patient shall be chosen by surgeon.

7. The operation procedure shall be carefully planned. The size of implant should be deter-mined prior to beginning the surgery. An adequate inventory of implant sizes should be available at the time of surgery, including sizes larger and smaller than those ex-pected to be used.

8. Unless supplied sterile, all implants should be cleaned and sterilized before use. Additional sterile components should be available in case of any unexpected need. Before surgery, the surgeon should ascertain that all implants and instruments are sterilized.

9. Before procedure, all components including instruments should be carefully checked to ensure that there is no damage on implant surface. Any damaged implant (surface damages, shape deformations) shall not be used.

10. The surgeon should be familiar with each element before using and should personally verify all needed devices before the surgery.

11. Where material sensitivity is suspected, appropriate tests should be made prior to ma-terial selection or implantation. Alloying elements of implant material, are presented in section IMPLANT MATERIAL.

RECOMMENDATIONS FOR IMPLANT PROVIDED STERILE Sterile implant - is delivered in sterile package, with the inscription: “STERILE”. Such

product is sterile and the manufacturer is responsible for the process of sterilization. Products have been exposed to a minimum of 25kGy of gamma radiation process.

Before using of the sterile product, the following rules must be applied:a) Check out the expiration date of sterilization.

Do not use the devices with overstepped sterility date.b) Check out if the sterile package is not opened and damaged.

Do not use the devices if sterile package is intact.c) Check out if sterility indicator on the sterile packaging is red, which indicates that ra-

diation sterilization of the product was performed.Do not use devices when the sterility indicator is other than red.

RECOMMENDATIONS FOR IMPLANTS PROVIDED NON-STERILEBefore using of the non-sterile product, the following rules must be applied:The device must undergo cleaning, disinfecting and sterilization procedures. It is rec-

ommended to use an automated procedure (washer-disinfector) for cleaning and dis-infecting.

Implant cannot be sterilized in the package, in which was delivered. Patient’s labels shall be protected from loss or destruction during process of clean-

ing and sterilization. These rules of cleaning and sterilization should be followed for all devices planned

to be inserted. Instruments used for implantation shall undergone cleaning and ster-

X. INSTRUCTIONS FOR USE



INSTRUCTIONS FOR USE

SYMBOL TRANSLATION • OBJAŚNIENIA SYMBOLI • ПОЯСНЕНИЕ ОБОЗНАЧЕНИЙ • EXPLICACIÓN DE LOS SÍMBOLOSDo not reuse

Nie używać powtórnieНе использовать повторно

No reutilizar

Do not resterilizeNie sterylizować ponownie

Не стерилизовать повторноNo reesterilizar

Do not use if package is damagedNie używać jeśli opakowanie jest uszkodzoneНе используйте при поврежденной упаковке

No utilizar si el envase está dañado

Sterylized using irradiationSterylizowany przez napromieniowanie

Стерилизация облучениемEsterilizado mediante radiación

Sterylized using ethylene oxideSterylizowany tlenkiem etylenuСтерилизация окисью этилена

Esterilizado mediante óxido de etileno

Non-sterileNiesterylny

НестерильноNo estéril

STERILE R STERILE EO NONSTERILE

Batch codeKod partii

Код партииCódigo de lote

Catalogue numberNumer katalogowyНомер по каталогуNúmero de catálogo

Consult instruction for useZajrzyj do instrukcji używania

Смотри инструкцию по применениюConsultar instrucciones de uso

LOT REF

MaterialMateriał

МатериалMaterial

QuantityIlość

КоличествоCantidad

Use byUżyć do

Срок годностиFecha de caducidad

Mat: Qty:

CautionOstrzeżenie

ПредупреждениеAdvertencia

ilization procedure. Preparation for cleaningRemove possible surface contamination using a disposable cloth, paper towel or plas-tic brushes (nylon brushes are recommended). Do not use brushes made of metal, bris-tles or materials which can cause implant failure. Cleaning and disinfecting processChosen washing and disinfecting detergents must be suitable and approved for use with medical devices. It is important to follow the instructions and restrictions speci-� ed by the producer of those detergent. It is recommended to use water solutions of cleaning-disinfection agents with a neutral pH.Manual cleaning

• Brushing carefully apply washing detergent (e.g. MEDICLEAN) to implant surfaces. A suitable brush must be used for cleaning holes.

• If applicable, ultrasonic cleaning may be performed. The ultrasonic bath must be pre-pared according to the manufacturer’s instructions.

• Next rinse thoroughly under � owing water. It is recommended to use demineralized water.

• Visually inspect the entire surface of the device for damages and contaminants. Damaged implants must be removed. For contaminated implants, the cleaning pro-cess should be repeated.Cleaning with washer-disinfectorThe device should undergo a process of machine washing in the washer-disinfec-tor (use washing-disinfecting agents recommended for medical devices). Procedure of washing with the washer-disinfector shall be performed according to hospital pro-cedures, recommendations of the washing machine manufacturer, and instructions for use prepared by manufacturer of washing and disinfection agents.Disinfection should be carried out at 93°C (soak for 10 minutes in demineralized water) without the use of detergents.DryingDrying must be performed as part of the cleaning/ disinfection process.SterilizationDisinfected, washed, and dried device shall undergo the sterilization process in accor-dance with the obligatory client procedures. The recommended method of steriliza-tion is steam sterilization (in water vapor) under overpressure:

- temperature: 134°C, -pressure: 2 atm. of pressure above atmospheric (overpressure), -minimum exposure time: 15 min, -minimum drying time: 20 min.CAUTION:

-Sterilization must be e� ective and in accordance with requirements of the EN 556 stan-dard, which states, that theoretical probability of living microorganism presence is less than 1/106 (SAL=10-6, where SAL stands for Sterility Assurance Level). - Implant must not be sterilized in the package in which was delivered.

RE-STERILIZATIONATTENTION: The user of the product bears all responsibility for re-sterilization. In such case the device shall be cleaned and sterilized in way described in chapter

RECOMMENDATIONS FOR IMPLANTS PROVIDED NON-STERILE.PRECAUTIONS1. Implant is intended for single use only. After removing the implant from the pa-

tient’s body it must not be re-used. Final disposal of implant shall be carried in accor-dance with current hospital procedures.

2. Under no circumstances is it allowed to reuse or reimplant once used device. Even if the removed implant appears to be undamaged it may have small latent defects or internal stresses, which could lead to an early implant breakage.

3. Implant which had contact with tissues and body � uids of the other patient can-not be reimplanted due to a potential risk of cross infection caused by viruses, bacteria and prions.

4. Avoid damaging implant surface and the deformation of implant shape during the im-plantation, the damaged implant cannot be left or implanted in the patient’s body.

5. Slippage or misuse of instruments or implants may cause injury to the patient or op-erative personnel.

6. Insertion, removal and adjustment of implants must only be done with instruments spe-cially designated for those implants, and manufactured by ChM. Ltd. Usage of ChM’s implants and instruments in combination with implants and in-struments from other manufacturers may cause damage or failure of those im-plants or instruments and may lead to improper course of surgery and heal-ing process.

7. Intraoperative fracture or breaking of instruments has been occasionally reported. Instruments, which have experienced extensive use or excessive force, are susceptible to fracture. It is recommends to inspect all instruments for wear and dis� gurement. Instruments should be examined for wear or damaged prior to surgery.

POST-OPERATIVE RECOMMENDATIONIt is essential to follow all physician’s postoperative directions and warnings.

1. It is essential to con� rm proper position of the implant by roentgenographic examina-tion.

2. In postoperative period, an immobilization of union should be con� rmed by roentge-nographic examination. If non-union occurres or if any components loosen, migrate, and/or break, the devices should be revised and/or removed immediately to avoid serious injury.

3. Surgeons must instruct patients regarding appropriate and restricted activities during consolidation and maturation for the fusion mass in order to prevent placing exces-sive stress on the implants which may lead to � xation or implant failure accompany-ing clinical problems. The implant can break or become damaged as a result of strenu-ous activity or trauma, and the device may need to be replaced in the future.

4. If the patient is involved in an occupation or activity which applies inordinate stress upon the implant (e.g. substantial walking, running, lifting, or muscle strain) the surgeon must advice the patient that resultant forces can cause failure of the device.

5. The patient should be warned about the risk of not following the rules above, or being unavailable for follow-up examination.

6. Surgeon must instruct patient to report any unusual changes of the operative site to his/her physician. The physician should closely monitor the patient if any change at the site has been detected.

7. The patient should be informed about type of implant material (titanium or titanium alloy).

8. The patient should be advised not to smoke or consume excess alcohol, during period of the bone fusion process.

CONSIDERATIONS FOR REMOVAL OF THE IMPLANT AFTER HEALINGSteel implant shall be removed after period of not more than two years after its im-

plantation.When bone union is achieved, the implants serve no functional purpose and may

be removed. The possibility of another surgical procedure and associated risks must be analyzed and discussed with the patient. The � nal decision on implant removal is up to the surgeon. In most patients, removal is indicated because the implants are not in-tended to transfer forces developed during normal activities.

If the device is not removed following completion of its intended use, one or more complications may occur, in particular:1. Corrosion, with localized tissue reaction or pain.2. Migration of the implant, possibly resulting in injury.3. Risk of additional injury from postoperative trauma.4. Bending, loosening and breakage, which could make removal impractical or di� cult.5. Pain, discomfort, or abnormal sensations due to the presence of the device.6. Possible increased risk of infection.7. Bone loss due to stress shielding.8. Potential unknown and/or unexpected long term e� ects.

Implant removal should be followed by adequate postoperative management to avoid fracture, re-fracture, or other complications.

If this instruction appears unclear, please contact the manufacturer, who shall provide all required explanation.

Updated INSTRUCTIONS FOR USE are available at the following website: www.chm.eu.IFU-010/13; Date of veri� cation: May 2013

REUSABLE ORTHOPAEDIC AND SURGICAL INSTRUMENTS

Instruments manufactured by ChM Ltd. are made of stainless steel, aluminium alloys and plastics according to ISO standards. Each medical instrument is exposed to occurrence of corrosion, stains and damage, if not treated with special care and recommendations below.

1. MaterialsDevices are produced of corrosion-resistant steels. The protective layer (passive layer) against corrosion is formed on the surface of the stain-less steel due to high content of chromium.Devices produced of aluminium are mainly stands, palettes, cuvettes and some parts of instruments such as handles of screwdriver, awl or wrench, etc. The protective oxide layer, which may be dyed or stay in natural colour (silvery-grey), is formed on the aluminium as an effect of electrochemical surface treatment on its surface. Devices made of aluminium with processed layer have a good corrosion resistance. The contact with strong alkaline cleaning and disinfecting agents, solutions containing iodine or some metal salts due to chemical interference on the processed aluminium surface shall be avoided.Devices are mainly manufactured out of following plastics: POM-C (Polyoxymethylene Copolymer), PEEK (Polyetheretherketone) and teflon (PTFE). The above mentioned materials can be processed (washed, cleaned, sterilized) at temperatures not higher than 140°C, they are stable in aqueous solution of washing-disinfection with pH values from 4 to 9.5.

If the material of the device cannot be specified, please contact ChM Ltd. company representative.

2. Disinfection and cleaningEffective cleaning is a complicated procedure depending on the following factors: the quality of water, the type and the quality of used deter-gent, the technique of cleaning (manual/machine), the correct rinsing and drying, the proper preparation of the instrument, the time, the tem-perature. Internal procedures of sterilizers, recommendations of cleaning and disinfection agents, as well as recommendations for cleaning and sterilizing automatic machines shall be observed.

Read and follow the instructions and restrictions specified by the manufactures of the agents used for disinfection and cleaning procedures.

1. Before the first use, the product has to be thoroughly washed in the warm water with washing-disinfecting detergent. It is important to follow the instructions and restrictions specified by the producer of those detergent. It is recommended to use water solutions of cleaning-disinfec-tion agents with a neutral pH.

2. After use, for at least 10 minutes the product has to be immediately soaked in an aqueous disinfectant solution of enzyme detergent with a netural pH (with a disinfection properties) normally used for reusable medical devices (remember to prevent drying out any organic re-mains on the product surface). Follow all the instructions specified by the producer of those enzyme detergents.

3. Carefully scrub/clean the surfaces and crevices of the product using a soft cloth without leaving threads, or brushes made of plastic, only the nylon brushes are recommended. Do not use brushes made of metal, bristles or damaging material as they can cause physical or chemical corrosion.

4. Next, thoroughly rinse the instrument under the warm running water, paying particular attention for carefully rinsing the slots. Use nylon brushes making multiple moves back and forth on the surface of the product. It is recommended to rinse in demineralized water, in order to avoid water stains and corrosion caused by chlorides, found in the ordinary water, and to avoid forming the stains on the surface such as anodized. During the rinsing manually remove the adherent remains.

5. Visually inspect the entire surface of the product to ensure that all contaminations are removed.

If there are any residues of human tissue or any other contamination, repeat all stages of the cleaning process.

6. Then, the instrument has to undergo a process of machine washing in the washer-disinfector (use washing-disinfecting agents recom-mended for reusable medical devices and instruments).

Procedure of washing with the washer-disinfector shall be performed according to internal hospital procedures, recommendations of the washing machine manufacturer, and instructions for use prepared by the washing-disinfection agents manufacturer.

3. SterilizationBefore each sterilization procedure and application, the device has to be controlled. The device is to be efficient, without toxic compounds as residues after disinfection and sterilization processes, without structure damages (cracks, fractures, bending, peeling). Remember that sterilization is not substitute for cleaning process!

Devices manufactured out of plastics (PEEK, PTFE, POM-C) may be sterilized by any other available sterilization method validated in the centre but the sterilization temperature is not to be higher than 140°C.

Sterilization of surgical instruments shall be carried out using equipment and under the conditions that conform to applicable standards. It is recommended to sterilize in steam sterilizers where sterilizing agent is water vapour. Recommended parameters of the sterilization method: temperature min. 134°C, pressure of 2 atm.

The above given parameters of sterilization are to be absolutely observed.

Validated sterilization methods are allowed. Durability and strength of instruments highly depend on their usage. Careful usage consistent with in-tended application of the product, prevents product damaging and prolongs its life.

SALES OFFICEtel.: + 48 85 713-13-30 ÷ 38fax: + 48 85 713-13-39

ChM Ltd.Lewickie 3b16-061 Juchnowiec K.Polandtel. +48 85 713-13-20fax +48 85 713-13-19e-mail: [email protected]

4 INTRAMEDULLARY OSTEOSYNTHESIS OF HUMERUS6 INTERMEDULLARY OSTEOSYNTHESIS OF FEMUR BY TROCHANTERIC

NAILS7 INTRAMEDULLARY OSTEOSYNTHESIS OF FIBULA AND FOREARM8 DYNAMIC HIP (DSB) CONDYLAR (DSK) STABILIZER9 SPINE STABILIZATION10 EXTERNAL FIXATOR15 TIBIAL AND FEMORAL ANGULAR SET BLOCK17 INTRAMEDULLARY OSTEOSYNTHESIS OF FEMORAL AND TIBIA

TELESCOPIC NAIL20 RADIAL HEAD PROSTHESIS KPS21 OPENING WEDGE OSTEOTOMY22 LOCKING PLATES23 OSTEOSYNTHESIS OF FEMUR REVERSED METHOD (CONDYLAR

APPROACH)24 INTRAMEDULLARY OSTEOSYNTHESIS OF FEMUR25 INTRAMEDULLARY OSTEOSYNTHESIS OF TIBIA28 INTRAMEDULLARY OSTEOSYNTHESIS OF FEMUR WITH TROCHANTERIC

ChFN NAILS

29 CERVICAL LOCKING PLATE SYSTEM30 PROXIMAL HUMERAL PLATE31 THE FEMORAL PLATES32 4.0 ChLP PLATES FOR DISTAL PART OF RADIAL BONE34 INTRAMEDULLARY OSTEOSYNTHESIS OF FEMUR WITH ANATOMIC

FEMUR NAILS35 SPINE STABILIZATION36 ChLP SCREWS REMOVING37 STABILIZATION OF THE PUBIC SYMPHYSIS38 INTRAMEDULLARY TIBIA OSTEOSYNTHESIS WITH CHARFIX2 NAILS39 IDS SYSTEM40 INTERVERTEBRAL CAGES PLIF PEEK CAGE42 STERNO-COSTAL PLATE43 INTRAMEDULLARY OSTEOSYNTHESIS OF HUMERUS45 RECONSTRUCTION PLATES - PELVIS FI XATION47 LOCKING PLATES 5.0ChLP48 LOCKING PLATES 7.0ChLP55 ELASTIC INTRAMEDULLARY NAIL FOR CHILDREN

48 plytki blokowane 70chlp en - cadeinstruments.com.mx · • comminuted fractures of the distal...

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