surgical technique *smith&nephew tc-plus™advanced...smith & nephew tc-plus advanced knee...

*smith&nephewTC-PLUS™AdvancedPrimary Knee System

Surgical Technique

Ligament balancing IExtension Gap First

Fixed Bearing Knee Systems

Sawblade thickness: 1.27mm

Celebrating

TC-PLUS™ Advanced

Ligament Balancing IExtension Gap First

Table of contents

Introduction .................................................................................4General Warnings and Comments ................................................ 5Indications / Contraindication ....................................................... 6Case Presentation ......................................................................... 7Preoperative Planning ................................................................... 8

Surgical Technique ................................................................... 10Positioning of the patient for surgery . ..........................................10Knee access .................................................................................11Sequence of main surgical steps .................................................12

Surgical Workflow . .....................................................................141. Tibia Preparation ....................................................................15 1.A Extramedullary (EM) Tibial Alignment .................................15 1.1 Positioning of the EM tibial alignment guide....................15 1.2 Adjustment of posterior slope ........................................15 1.3 Determination of rotation ...............................................16 1.4 Adjustment of resection depth .......................................16 1.5Tibialcuttingblockfixation ............................................18 1.6 Alignment control ..........................................................18 1.7 Varus / valgus correction ..............................................18 1.8 Tibial resection ..............................................................19 1.B Intramedullary (IM) Tibial Alignment ................................... 20 1.1 Positioning of the IM tibial alignment guide .................. 20 1.2 Alignment control ..........................................................21

2. Femoral Preparation ..............................................................22 2.1 Intramedullary femoral alignment ................................. 22 2.2 Distal femoral resection ............................................... 23 2.3 Check extension gap ................................................... 27 2.4 Determination of femoral rotation ................................ 28 2.5 Femoral rotation & sizing ............................................. 29 2.6 Femoral resection ........................................................ 32

3. Trial Reduction and final preparations ...............................34 3.1 Check of Flexion and Extension Gaps ........................... 35 3.2 Removal of osteophytes ............................................... 35 3.3 Tibial sizing ................................................................. 35 3.4 Tibial rotation ................................................................ 36 3.5A-Trialreductionandfinalfemoral preparation CR / CS .............................................. 36 B-TrialreductionandfinalfemoralpreparationPS ..... 39 3.6 Preparation of tibial anchorage..................................... 42

4. Patella Preparation ...............................................................43 4.1 Patellar resection ..........................................................43 4.2 Patellar sizing ..............................................................43 4.3 Patellar Milling .............................................................44 4.4 Drill anchoring holes ...................................................44 4.5 Trial insertion and reduction ........................................44

5. Implantation of Implant Components ..................................45 5.1 Tibial and femoral implantation .................................... 45 5.2 A - Implantation of cemented implant components ..... 45 B - Implantation of non-cemented

(porous) implant components (CR/CS) ................... 45 5.3 Implantation of the patellar component ....................... 47

6. Wound closure ...................................................................... 47

Sterilization of Implants and Instruments ..............................48

References .................................................................................49

Appendices ...............................................................................50Appendix A - Assembly of Ligament Tensioner (6 steps) ..............................50 Appendix B - Instrument Program ........................................................51Appendix C - Implants .................................................................... 68Appendix D - X-Ray Templates .......................................................... 74Appendix E - Sawblades and Speedpins Portfolio....................................... 75Appendix F -Maintenanceandverificationofinstruments with a measuring function .................................................. 76

Nota Bene

The technique description herein is made available to the healthcare professional to illustrate the authors’ suggested treatment for the uncomplicated procedure. In the final analysis, the preferred treatment is the one which addresses the needs of the patient.

4

Introduction

Smith & Nephews TC-PLUS™ Total Knee system was first implanted in 1996. Since the first clinical application the wide range of the implant offering, the precise and efficient instrumentation assure the systems reliability and success which are reinforced with solid clinical results (latest ODEP ratings can be found at www.odep.org.uk).

Continuous further developments have culminated in today’s TC-PLUS Advanced Knee System:

Smith & Nephew TC-PLUS Advanced Knee System offers surgeons a wide choice of implant components, providing the clinician with greater flexibility to address a broad range of patients, taking into account each patient's size, anatomy and knee function.

Our Swiss based team designed both the components and instruments to meet surgeon’s demands. The instrument system offers means to assess the level of the knee joint line and the ligamentous situation. The system further allows choosing the appropriate level of constraint in order to achieve the required knee stability and kinematics.

Smith & Nephew understand that above mentioned factors contribute to the long-term survival and clinical success in knee arthroplasty.

A special thank goes to the following design surgeons who developed and reviewed the surgical workflows:

Dr Jerôme Grobost, Le Mans, France (Measured Resecation I / Femur First)

Ass. Prof Oliver Kessler, Zürich, Switzerland (Ligament Balancing I / Extension Gap First)*

Prof Nicola Pace, Ancona, Italy (Measured Resection II / Extension Gap First)

Prof José Romero, Zürich, Switzerland (Ligament Balancing I / Extension Gap First)*

* Surgical workflow described in this document

5

General Warnings and Comments

Warnings They are written in orange. They must be followed as they relate to critical functions.

Comments They are written in blue. This information should be noted as it contains valuable advice which helps the user to clinically apply the system.

Training: Only adequately trained operators should use the TC-PLUS™ Advanced Primary Knee System. This Surgical Technique must be fully read and understood as part of the training. If any part of this documentation is not clear, please contact your Smith & Nephew representative.

Implants: TC-PLUS Advanced Primary Knee System components are only designed for use with the indicated Smith&Nephew implants and instruments. Implants and instruments must be used in accordance with the instructions in all other relevant Surgical Techniques.

Responsibility: It is the responsibility of the user of the TC-PLUS Advanced Knee System to review all relevant information concerning the product before use. All the information provided in the Instructions for Use and in the Surgical Technique are to help the user in preparing for use of the product. The user must check all recommendations concerning the product in the Instructions for Use and in the Surgical Technique and is responsible for all clinical decisions taken.

Cleaning and Sterilization: All instruments must be sterilized before use. Detailed information on cleaning and sterilization of instruments is contained in the separate cleaning and sterilization instructions No. 03389.

Additional Warnings: Warnings and comments cited in other Surgical Techniques relating to TC-PLUS Total Knee System must also be followed.

6

Indications

The principal preoperative planning factor is the correct diagnosis. It has to be determined whether the bone and stability situation allow the implantation of an uncoupled prosthesis.

The indications for the TC-PLUS™ Advanced Primary Knee System are the following:• Advanced degeneration of the knee joint as a result of

degenerative, posttraumatic or rheumatoid arthritis

• Avascular necrosis of the femoral condyles

• Moderate varus, valgus or flexion deformity

Contraindications

The contraindications for the TC-PLUS Advanced Primary Knee System are the following:• Acute or chronic infections, local or systemic

• Local infections of the area operated

• Severe muscle, nerve or vascular diseases that endanger the extremity in question

• Missing condylar support, lacking bone substance or inadequate bone quality that endangers a stable seating of the prosthesis

• All concomitant diseases that may endanger the function of the implant, such as any allergies to implant materials

• High-grade instabilities

• Extreme physical activity (e.g. competitive sport, heavy labour)

See also instructions on the package insert.

Important

TC-PLUS™ Advanced Primary PS implant components are not compatible with TC-PLUS™ PRIMARY PS implant components and cannot be combined (see Appendix C).

Prior to the use of any instrument, users must follow instructions set out in Appendix F regarding checks of instruments with a measuring function.

This verification must be performed before each time an instrument is used.

7

Case Presentation

Preoperative

72-year-old male patient, medial osteoarthritis of the knee, preoperative status.

Frontal and lateral view

Postoperative Functional and pain-free reconstruction with TC-PLUS™ Advanced Primary CR, cemented femoral and cemented tibial component.

Frontal and lateral view

Pre- and postoperative

Axial view of thepatello-femoral joint(preoperative situation)

A non-resurfaced patella, articulating with a TC-PLUS™ Advanced Primary CR femoral component (postoperative situation)

8

Preoperative Planning

An antero-posterior and lateral X-ray of the knee and a skyline or axial view of the patella is required. A full-leg X-ray with the patient in the standing position is recommended for preoperative planning purposes.

X-ray templates are available for preoperative planning. The lateral view of the condyles is decisive. If the condyles are damaged, it is recommended to reference of the condylar width.

Oversizing of the implants has to be avoided. Correct size and correct positioning of the implant has to be controlled intraoperatively.

NoteCombination of different implant sizes is possible:

Femoral and tibial components can be combined, both one component size up and down.

ImportantThe combination of TC-PLUS PRIMARY implant components is allowed within the TC-PLUS product family only.

PS version

size 2 4 / 4S 6 / 6S 8 / 8S 10 12

size 2 4 6 8 10 12

size 2 4 6 8 10 12

Tibia Components Fixed bearing left / right

cemented

PS Femoral Components left / right

cemented

PS Tibial Inserts

symmetric

19mm

17mm

15mm

13mm12mm11mm10mm9mm

CR and CS version

size 2 4 / 4S 6 / 6S 8 / 8S 10 12

size 2 4 6 8 10 12

size 2 4 6 8 10 12

CR/CS Femoral Components left / right

cemented / non-cemented

CR/CS Tibial Inserts

symmetric

Tibial Components Fixed bearing left / right

cemented / non-cemented

19mm

17mm

15mm

13mm

11mm

9mm

9

Preoperative Planning

The following procedure is recommended for the A/P whole-leg imaging process:

Preoperative planning: The following procedure - planned on a standing long-leg radiography - is recommended:

1. The angle between A and D determines the anatomical valgus angle α of the femoral shaft. This angle α will be used to select the correct femoral bushing to perform the distal femoral cut in the correct plane (see page 23).

2. The goal of the surgery is to align the mechanical axis of the femur D and the tibial axis B with the mechanical axis C.

Conventional X-ray templates and digital ones (for EOS imaging) are available for planning (see Appendix D, page 74).

αA

B

C

D

A Anatomical femur axisB Anatomical tibia axisC Mechanical leg axisD Mechanical femur axis α Valgus angle

ABCD

α

A

C

10

Surgical Technique

Position of the patient for surgerySurgery is performed whilst the patient is in supine position. Tourniquet can be used.

The leg must be covered and secured to the operating table, still to allow movement in order that the knee joint can be positioned in a stable 90° flexion position.

Most of the surgical steps are performed in this position.

11

Knee accessThe skin incision may be undertaken as a midline or para-patellar incision.

If present, the scars of previous skin incisions from earlier operations should be used in order to reduce the risk of cutaneous blood flow disorders. Medial arthrotomy is recommended.

After the usual preparation (meniscus resection, removal of osteophytes, synovectomy if necessary), the anterior cruciate ligament is resected. This will provide good exposure of the individual knee sections.

12

Sequence of main surgical steps

1. Skin incision

2. Tibial resection

3. Distal femoral resection

4. Check extension gap with spacer

5. Ligament balancing, soft tissue releases (if required)

6. Determination of femoral component rotation (creation of rectangular flexion gap based on ligament tension)

Page 28

Page 27

Page 26

Page 23

Page 19

Page 11

13

8. Femoral resections

9. Femoral box preparation (PS)

10. Trial reduction CR/CS

10. Trial reduction PS

11. Tibial preparation

12. Patella preparation

13. Component implantation

1.27mm saw blades must be used for all bone resections

7. Femoral sizing

Page 45

Page 42

Page 43

Page 38Page 42

Page 39

Page 32

Page 28

14

Approach Please refer to the relevant surgical textbooks for the initial approach to the knee.

NoteIn addition to the bone resections it is important to correct any ligament imbalances by corresponding soft-tissue procedures.

If necessary, a general release should be performed on the side of the contracture prior to the bone resections. Additionally, any osteophytes on the femur and tibia should be removed. This will produce good exposure of the individual knee sections, thus facilitating size determination.

It is recommended to use sawblades and fixation speedpins listed in the Appendix E, page 75. If standard fixation pins are used, it is recommended to pre-drill the holes to prevent lift-off of cutting blocks.

Surgical Technique

15

1.1 Positioning of the EM tibial alignment guide

Mount the tibial cutting block [B] on the extramedullary tibial alignment guide [A] and secure the block with the central screw.

Assemble the tibial alignment guide [A] with the guide tube [C]. Secure the guide tube [C] on the distal end of the lower leg using the ankle fork [D].

Adjust the overall length of the alignment guide [A] to the length of the tibia and secure it with the screw. [E].

Anchor the proximal end of the guide tube to the central tibial plateau by gently hammering the longer spike into the bone.

Position the tibial alignment guide in the center of the ankle by turning the screw on the side of the ankle fork [G] and positioning the guide in the correct M/L position. Make sure, that the alignment guide is aligned parallel to the tibial axis in the coronal and sagittal planes and is locked on the distal end.

1.2 Adjusting the posterior slope

Adjust the posterior slope of the tibial cutting block by turning the yellow screw with the screwdriver.

The posterior slope can be adjusted continuously from 0 to 9 degrees.

The scale on the left side of the cutting block shows the adjusted degrees of the posterior slope.

NoteThere is no inclination built into the tibial cutting block nor into the tibial component.

For a PS and CS design a 0-3 degree posterior slope is recommended.

For a CR design it is recommended to match the patient’s natural slope (up to max. 7 degrees of posterior slope).

NoteIt is useful to place the resection stylus on the upper surface of the cutting block.

This way, the natural slope of the tibial joint surface can be assessed.

1. Tibial Preparation 1.A Extramedullary (EM) Tibial Alignment

Instrument assembly

ImportantExcessive posterior slope can increase the likelihood of the femoral component impinging with the anterior aspect of the articular surface spine. At 3 degrees of tibial slope the liberty for hyper- extension is 5 degrees for a PS implant system.

A

B

CD

E

F G

16

1.3 Determining rotation

The following criterion serves as a rotation guide for the extramedullary tibial alignment guide:

The center of the alignment guide is located slightly to the third medial side of the tibial tubercle, the distal tibialis anterior tendon, the anterior tibial spine or the second metatarsus axis (especially in case of previous surgical tibial tubercle osteotomy).

When the rotation has been determined, hammer both bone pins home.

1.4 Adjusting the resection depth

As a general rule, a conservative tibial resection is recommended.

The desired resection level can be determined through preoperative planning.

Adjust the resection level on the tibial stylus to the desired level. Insert the tibial stylus into the tibial cutting block.

Adjust the resection level of the tibial cutting block and use the central set screw to lock the position with the screwdriver.

1. Tibial Preparation1.A Extramedullary (EM) Tibial Alignment

17

Tibial stylus optionsThe tibial stylus always shows the resection level (versus the level where it touches the bone).

Standard Tibial Stylus J/DThe stylus can be positioned either in the “J” position for Joint line level or in the “D” position for Defect bone level.

The “J” position is especially used for unicompartmental (usually medial) defects.

In this position the stylus is referenced on the intact (usually lateral) side in the center of the compartment and measures the resection level of the lowest PE-inlay. If the resulting resection is inadequate, proceed as for bilateral defects in order to reach the lowest point of the damaged compartment.

In case of extensive bicompartmental defects place the stylus into the “D” position at the lowest point of the tibial plateau. In “D” position the resection level will be 1mm below the point of contact

Optional Tibial Stylus (adjustable)The stylus can be adjusted continuously from 0 to 14mm according to the desired resection level.


Tibial Stylus J / D

Tibial Stylus adjustable

1mm

18

1.5 Tibial cutting block fixation

Pin the tibial cutting block into place in at least two of the 0mm resection holes.

Open the two proximal screws (on the cutting block and the alignment guide) and remove the proximal part of the alignment guide by tapping the proximal part with the slap hammer.

1.6 Alignment control

If desired, the load axis can be checked using the external alignment tower and the alignment rod mounted on the tibial cutting block.

1.7 Varus / valgus correction

If the distal end of the axial alignment rod does not pass over the midpoint of the ankle, the tibial cutting block can be exchanged by the (varus/ valgus) correction cutting block.

The tibia can then be resected at an angle of 2° more in valgus.

A corresponding correction in varus is achieved by turning the block around. The load axis is rechecked with the alignment tower and alignment rod.


19

1.8 Tibial resection

For a better stability it is recommended to fix the tibial cutting block with at least one oblique pin (marked by orange circles).

Check the tibial resection level by inserting the resection stylus in the anterior slot of the tibial cutting block.

Perform the tibial resection with the oscillating 1.27mm saw blade.

NoteEnsure that the posterior cruciate ligament remains intact during the tibial resection.

First remove the oblique pin and then the Tibial Cutting Block.

If an additional tibial resection is required, place the tibial cutting block over the straight pins through the +2mm or +4mm holes.

Place at least one oblique pin and recut the tibia.

Position the knee in deep flexion. Place a thin bent Hohmann laterally and medially. The tibia is subluxed anteriorly with a tibial retractor.

Determine the tibia size using the Tibia Sizer with the attached tibial handle. Tibial sizing templates are available in all sizes for left and right knee.

The tibial sizing template is selected which provides best bone coverage without overhang.

NoteThe size of the tibia component is required during the femoral sizing step (on page 30)


20

1.1 Positioning of the (IM) tibial alignment guide

Open the tibial canal with the Ø 8mm preparation drill.

Position the hole centrally in the M/L plane and in the anterior third in the A/P plane. This ensures ideal positioning of the rod.

Slowly insert the intramedullary rod with T-handle into the tibial canal. Remove the rod again.

Slide the tibial cutting block over the intramedullary alignment guide down the rod and lock it with the central set screw.

Insert the intramedullary rod in conjunction with the assembled intramedullary alignment guide.

Determine the rotation as described on page 16.

1. Tibial Preparation1.B Intramedullary (IM) Tibial Alignment

21

1.2 Alignment control

If desired, the load axis can be checked using the external alignment tower and the axial alignment rod mounted on the tibial cutting block.

The axial alignment rod should pass over the center of the ankle.

If the distal end of the axial alignment rod does not pass over the midpoint of the ankle the varus/valgus position of the cutting block can be adjusted.

Open the screw on top of the proximal part of the intramedullary tibial guide and adjust the intramedullary alignment guide in the desired varus/valgus angle. The set screw is locked in the adjusted angle.

Proceed as described on page 15 (1.2 Adjusting the posterior slope).

Final alignment must be checked using the alignment rod.

1. Tibial Preparation1.B Intramedullary (IM) Tibial Alignment

22

2.1 Intramedullary femoral alignment

Remove osteophytes. If necessary, perform a (partial) synovectomy, expose the intercondylar notch.

Locate the intramedullary (IM) femoral drill guide centrally in M/L alignment approximately

0.5 to 1 cm anteriorly to the insertion point of the posterior cruciate ligament.

The intramedullary femoral drill guide has three holes for inserting a long pin or external alignment rod to indicate the direction of the central hole.

Open the femoral canal using the Ø 8mm preparation drill.

Slowly insert the intramedullary (IM) rod with T-handle into the femoral canal with rotational movements.

Remove the rod.

2. Femoral Preparation

Anatomical axis

23

B

A

C

2.2 Distal femoral resection

Select the appropriate femoral bushing – either 4°, 6° or 8° (optional bushings of 5° or 7° are available) – as determined during the preoperative planning.

Insert the bushing into the femoral suspension device so that the “L” (left knee) or “R” (right knee) marking is visible at the top, depending on the side to be operated [A].

Slide the distal femoral cutting block onto the suspension device (arrow to arrow) and fix it at your desired cutting resection depth [B].

The distal femoral cutting block will slightly snap in position at 9mm. Fix the femoral cutting block with the golden set screw [C].

NoteThe saw capture must point to the distal side of the cutting block and the golden screw has to be on top.

The cutting block can also be fixed in a proximal or distal position if more or less distal bone needs to be resected according to the anatomical situation of the patient.

NoteThe distal and posterior thickness of the femoral component is 9mm.


Femoral bushing 6° left and right

Instrument assembly

9mm

24

2.2 Distal femoral resection (continued)

Positioning of distal femoral cutting block

Slide the distal femoral cutting block assembly over the IM rod with T-handle into the bushing and push the suspension device forward until it touches the most prominent part of the distal femur.

The MIS handle (optional) can be used to better hold and push the assembly.

Align the suspension device parallel to the posterior condlylar axis.

If desired, secure the suspension device with a pin distally.

Secure the distal cutting block to the anterior femur with pins through the holes marked “0”.


25


Alignment control Before the distal cut is performed, check whether the femoral cutting block is positioned at the right angle to the load axis of the knee: Place the alignment rod into the bushing of the suspension device.

The alignment is correct when the axial alignment rod lies over the midpoint of the femoral head. If it does not pass through this point the distal femoral cutting block can be exchanged for the 2 degrees (varus/valgus) correction cutting block.

This allows the distal femoral cut to be corrected at an angle of 2° more in varus or, by turning the block around, in 2° of valgus.

The load axis is rechecked using the external alignment tower and the alignment rod.

Remove the distal pin from the femoral suspension device, the IM rod and unlock the golden set screw of the distal femoral cutting block.

The femoral suspension device can now be removed.


26


The femoral cutting block should be fixed with at least one additional oblique pin (marked by orange circles).

Check the level of the distal resection by inserting the resection stylus in the slot of the distal femoral cutting block.

Perform the distal femoral resection.

A 1.27mm sawblade is used for all femoral and tibial resections.

To avoid overheating of the bone, perform all resections under cooling.

Remove the oblique pin first and then the distal femoral cutting block.

If an additional distal femoral resection is required, place the cutting block over the straight pins through the +2mm or +4mm holes.

Place at least one oblique pin and recut the distal femur.

2.3 Check of extension gap

Insert the spacer which corresponds to the lowest PE tibial insert height (9mm) in order to check the height of the extension gap.

NoteAfter insertion of the spacer make sure that full extension is achieved.


27

2.3 Check of extension gap (continued)

Situation 1: Spacer fits in Proceed to ligament balancing in extension

Situation 2: Spacer does not fit in Check whether it is due to an inappropriate bone resection or a unilateral soft tissue contraction.

In case of

2a) inappropriate bone resectiona. recut femur or tibia b. re-check with spacer c. if it fits in, proceed to ligament

balancing in extension

or in case of

2b) unilateral soft tissue contraction d. proceed to “Ligament balancing in

extension”

Assemble the ligament tensioner as described in Appendix A (page 50). The scales on the ligament tensioner indicate

• the applied load in Newton [N]

• the medial and lateral extension gap distance in [mm]

• the femoral rotation in [ ° ] in flexion

• the corresponding PE insert height in [mm]

Ligament balancing in extensionInsert the ligament tensioner into the knee in full extension. Apply a force in a physiological range to distract the knee (do not exceed a max. value of 120N).

If the tensioner reveals a ligament imbalance (= asymmetric extension gap) perform sequential soft tissue releases in extension and check ligament balance with the tensioner again.

Extend the soft tissue release until a rectangular extension gap is achieved.


28

2.4 Determination of femoral rotation

Once the knee is well balanced in extension the ligament tensioner is inserted into the knee in 90° of flexion and an equal distraction force on the medial and lateral side is applied (do not exceed a max. value 80N).

Read and memorize the value of the femoral rotation which will be required in the next step.

The following table shows the correspondence between the gap difference (= medial - lateral gap height) and the femoral rotation angle.

2.5 Femoral rotation & sizing

Femoral sizer (I/II)A. The Femoral Sizer (I/II) indicates the size of

the femoral component.

B1: The Yellow Screw on top adjusts the AP position of the femoral component in order to avoid an overhang of the femoral shield or notching of the anterior cortex.

B2: Scale to indicate the AP shift [mm] of the femoral component if B1 is used.

C: Screw to set the rotation of the femoral component (read the scale “Left” when applied on a left knee)

By turning the yellow set screw, the correct size and A/P position is set [B2].

Set the sizer in the neutral position by turning the yellow screw [B1] (arrow to zero position as shown in scale [B2). Start at zero position.

The external rotation can be continuously adjusted from 0 to 10 degrees external rotation with the screw driver.

The scales show the degrees of rotation of the femoral component (versus the posterior condyles).


B1

A

B2

C C

NoteIf the ligament balancing requires internal femoral rotation use the scale of the contra-lateral side to set the femoral rotation.

Gap difference Angle

2mm 3°

3mm 4°

4mm 5°

Gap difference Angle

5mm 6°

6mm 7°

7mm 8°

29

2.5 Femoral rotation & sizing (continued)

Positioning of the Femoral Sizer (I/II)Insert the sizing stylus into the proximal part of the Femoral Sizer (I/II).

Place the Femoral Sizer (I/II) flush to the distal cut surface and make sure that the paddles are in contact with the posterior femoral condyles.

Secure the Femoral Sizer (I/II) on the bone using pins.

NoteAll necessary adjustments such as AP shift and femoral rotation can be performed after fixation!

Femoral rotational alignment

The final rotation of the femoral component can be adjusted from 0 to 10 degrees with the screw driver.

Set the measured femoral rotation determined in flexion (see 2.4 on page 28).

Important The scale to set the external femoral rotation for a left knee is indicated with “LEFT” and the one for a right knee is indicated with “RIGHT”.

The scale shows the degrees of rotation between the implant and the posterior condyles.


30


Femoral SizingSet the stylus length on the longitudinal scale to the value which corresponds to the tibial size, determined at the tibia sizing step (see 1.8 on page 19, e.g. size “6”).

Position the tip of the stylus onto the anterior surface of the lateral femur. The best contact point (which serves as anterior sizing reference) is the transition to the lateral third (lateral run-out of the patellar groove).

Read the size above the arrow. In this example a femur component size 6 fits perfectly.

If the previously set stylus length value does not correspond with the red femur size value then readjust the stylus length and proceed again as described in this section “femoral sizing” in order to determine the correct femoral component size.

Anterior/posterior referencing

With the Femoral Sizer (I/II), both anterior and posterior referencing is possible.

Read the size on the scale.

If the scale shows an in-between size the decision has to be made either to perform an anterior or posterior referencing.


In this example: in between size 4 and 6

31


Anterior referencingTurn the yellow screw with a screwdriver to shift the A/P position until the next smaller size is reached while the stylus remains in contact with the bone surface.

Posterior referencingTurn the yellow screw with a screwdriver to shift the A/P position until the next larger size is reached while the stylus remains in contact with the bone surface.

Measuring and drill guide for the implant sizeAfter determination of the rotation and femoral size the Femoral Cutting Control Guide (optional) might be used together with the Reduction Insert (drill template) to determine the anterior cut accuracy using the resection stylus.


Anterior referencing: A/P adjustment to smaller size 4

Anterior referencing: A/P adjust-ment to smaller size 4

32


Position the reduction insert (drill template) onto the Femoral Sizer (I/II). It serves to drill the 2 holes for the 4-in-1 femoral cutting bock and to get a rough idea of the ML width of the femoral component.

Use the Ø 3.2mm drill to drill the peg holes for the 4-in-1 femoral cutting block. Remove the pins and the Femoral Sizer (I/II).

2.6 Femoral resections

Use the 4-in-1 femoral cutting block of the previously determined size to finalize the femoral resection.

The universal handle with the appropriate adapter can be used for positioning the 4-in-1 femoral cutting block and must be removed during the resections.

Perform a final check of the level of the anterior and posterior resections using the resection stylus.

Use the AP correction block, only if required. It allows to shift the level of the anterior and posterior cuts by either 2mm or 4mm anteriorly or posteriorly in order to avoid notching anterior overhang.

Caution! The use of the AP correction block will compromise the flexion gap!


33

2.6 Femoral resections (continued)

Pay attention that the 4-in-1 femoral cutting block lies flush on the distal femoral cut surface.

If the level of the anterior cut and the femur size are correct the cutting block must be secured using longer oblique pins for better stability prior to perform the resections.

Check again the anterior resection level by inserting the resection stylus in the anterior slot of the femoral cutting block.

Protect the collateral ligaments.

Perform the resections in the following order:

• anterior cut

• posterior cut

• chamfer resections

Note This order ensures the best stability of the cutting block during resections.

Remove pins and the 4-in-1 cutting block after completion of all femoral resections.


34

For cruciate retaining (CR), Cruciate Substituting (CS) and Posterior Stabilized (PS) procedureThe implant range offers the opportunity to choose or switch intraoperatively from a cruciate retaining prosthesis (CR) to a cruciate substituting (CS) or posterior stabilized (PS) prosthesis.

In case of posterior cruciate ligament (PCL) insufficiency and/or if the PCL has to be/is sacrificed during the operation, e.g. with flexion contractures over 30°, there is a threat of dorsal instability in flexion.

A cruciate substituting (CS, “deep dished”) or posterior stabilized (PS) tibial insert for cemented implantation is available to address this kind of insufficiency.

The PS option includes a femoral component that incorporates a box in the area of the intercondylar notch and a cam which interacts with the post of the tibia insert.

This post/cam mechanism controls the femoral roll-back.

The same tibial component is used for the CR, CS and PS option.

3. Trial Reduction and final preparations

CR

CS

PS

35

3.1 Flexion and extension gaps

Both the flexion gap (90° flexion) and extension gap are assessed by using the modular femoral and tibial spacer blocks.

A set of modular spacer blocks measures the gap and indicates the appropriate thickness of the tibial insert.

3.2 Removal of osteophytes

The femoral trial is used as a reference for the removal of any residual posterior condyles with the curved osteotome.

Use the curved osteotome to remove all osteophytes on the residual posterior condyles. At this time, a posterior contracture can also be released. This will improve flexion and prevent possible damage of the polyethylene insert by these bony parts.

This step is especially important for the posterior stabilized version.

Remove the Femoral Trial to gain space, if required.

3.3 Tibial sizing

Position the knee in deep flexion and place a thin bent Hohmann retractor laterally and medially. The tibia is subluxed anteriorly with a tibial retractor.

Insert the tibial sizer (template) together with the attached tibial sizer handle. Tibial sizers are available in all sizes for left and right knee (asymmetrical tibial sizers).

The appropriate tibial size is determined by the tibial sizer which provides best bone coverage (on cut tibia) without overhang.


36

3.4 Tibial rotation

The attached tibial handle aligns with the anterior aspect of the tibia.

Rotate the Tibial Sizer to the appropriate rotational position (landmarks to be used: tibial tubercle, distal tibialis anterior tendon, anterior tibial spine or the second metatarsus axis.

Use short bone pins with head to secure the tibial sizer.

3.5 A Trial reduction and final femoral preparation CR / CS

Assemble the Tibial Trial Insert Modular with the Tibial Trial Insert Baseplate, in case a PE height > 13mm is required.

E.g. attach the 9mm CR or CS Tibial Trial Insert Modular onto the Tibial Trial Insert Baseplate 6mm to create e.g. a 15mm tibial insert (see table).

Put the Femoral Trial onto the femur.

Insert the CR Tibial Trial Insert into the Tibial Sizer.

The femoral / tibial holder (optional instrument) is used to position the femoral trial.

Click the femoral holder insert onto the femoral / tibial holder. Assemble the femoral / tibial holder and the modular handle. Mount the femoral trial onto the femoral / tibial holder by opening and then releasing the clamp.


Tibial Trial Insert (total) height

Tibial Trial Insert only

9mm 11mm 13mm

Tibial Trial Insert with Baseplate +6mm

15mm 17mm 19mm

37

3.5 A Trial reduction and final femoral preparation CR / CS (continued)

Maximize bone coverage of the Femoral Trial and avoid any medial or lateral overhang.

The width of the Femoral Trial corresponds to the standard femur component.

ImportantThe ML widths of the Femoral Trials size 12 (left/right) are 2 mm narrower than the standard CR femoral components (implants) size 12!

In case of ML Femoral Trial overhang the use of the Sizing Template Fem slim R/L gives guidance if a slim femoral component fits better in ML.

Remove the Trial Femur and put the Sizing Template Fem slim R/L onto the femur.

The difference in ML width between standard and slim femoral components is 4mm for all sizes. Slim sizes 4S, 6S and 8S are available.

NoteAlign the Sizing Template Fem slim R/L medio- laterally for best bone coverage.

Mark the femur (indicated by red line) at the level of the line marking on the template.

Position the Femoral Trial back onto the femur (ML alignment with marked line).

Position the knee into full extension, with the tibial handle attached to the tibial sizer.

Pass the axial alignment rod through the tibial handle and check again full leg alignment.


38

3.5 A Trial reduction and final femoral preparation CR / CS (continued)

The Femoral Trial should be aligned medio- laterally in accordance with the anatomy, both to maximize bone coverage and achieve optimal patellar tracking.

Drill through the 2 holes of the femoral trial using the Drill with stop Ø 8mm to prepare the cavity for the femoral anchorage pegs.

Use the femoral bolts to better stabilize the femoral trial.

Prepare the trochlear fossa with the trochlear chisel.

Position the CR/CS Femoral Insert Trial onto the Femoral Trial.

Insert the appropriate height of the CR Tibial Trial Insert into the Tibial Sizer.

Start with the 9mm Tibial Trial Insert.

In case of a too lose knee increase the Tibial Trial Insert thickness.

Perform final check of range of motion, implant fit, stability of the knee joint and patella tracking.

Control and make sure that the knee can achieve full extension.


39

3.5 B Trial reduction and final femoral preparation PS

Maximize bone coverage of the Femoral Trial and avoid any medial or lateral overhang.

The width of the Femoral Trial corresponds to the standard femur component.

In case of ML Femoral Trial overhang the use of the Sizing Template Fem slim R/L gives guidance if a slim femoral component would fit better in ML.

The difference in ML width between standard and slim femoral components is 4mm for all sizes.

Slim sizes 4S, 6S and 8S are available.

NoteAlign the Sizing Template Fem slim R/L medio- laterally for best bone coverage. Mark the femur (indicated by red line) at the level of the line marking on the template.

Position the Femoral Trial back onto the femur (ML alignment with marked line)

Mount the PS Box Preparation Guide (1) into the distal 2 holes of the Femoral Trial (2).

Fix both the Femoral Trial (2) and the PS Box Preparation Guide (1) with pins.


1

2

40

3.5 B Trial reduction and final femoral preparation PS (continued)

Insert the PS Box Preparation Bushing (3) into the PS Box Preparation Guide (1) and lock the lever (4).

Use handles (optional) which can be attached to the PS Box Preparation Guide to better stabilize assembled instruments by hand.

Drill the 4 holes through the PS Box Preparation Bushing (3) to prepare the PS box.

Cut residual bone bridges by 3 chisel cuts.

Unlock the lever (4) and remove the PS Box Preparation Bushing (3).

Remove fixation pins and the PS Box Preparation Guide (1).

Remove residual bone in the PS box cavity, if required


34 2

1

4

1

3

3

41

3.5 B Trial reduction and final femoral preparation (PS, continued)

Prepare the trochlear fossa with the trochlear chisel.

Insert the PS Box Insert into the Femoral Trial.

Insert the PS Tibial Trial Insert into the Tibial Sizer.

Start with the 9mm tibial trial insert. In case the knee is too loose increase the trial insert thickness.

Assemble the Tibial Trial Insert Modular with the Tibial Trial Insert Baseplate in case a PE height > 13mm is used.

E.g. Attach the Tibial Trial Insert Base Plate 6mm to the 9mm PS Tibial Trial Insert Modular to create a 15mm Tibial Trial Insert.

Insert the assembled Tibial Trial Insert into the tibial sizer.


Tibial Trial Insert (total) height

Tibial Trial Insert only

9mm 11mm 13mm

Tibial Trial Insert with Baseplate +6mm

15mm 17mm 19mm

42

3.5 B Trial reduction and final femoral preparation (PS, continued)

Insert the PS Box Insert into the Femoral Trial.

Insert the PS Tibia Trial Insert.

Check range of motion, implant fit and stability of the knee joint and patella tracking.

Make sure that you achieve full extension.Determine the tibial rotation.

3.6 Preparation of tibial anchorage

Remove the femoral trial and tibial trail inserts.

Ream the tibial canal using the tibial stem drill.

Chose the correct size of the tibial rasp and prepare the stem cavity.

Remove the bone pins with head and tibial sizing template by using the pin extractor or slap hammer.


43

4.1 Patellar resection

After positioning the patellar clamp grasp the patella with the clamp. Turn the knob in a clockwise direction to tighten the clamp. Fix the clamp by depressing and turning the knob on the top side of the clamp in a clockwise direction.

Measure the patella thickness with the thickness indicator. The patellar thickness can be read from the millimetre scale on the handle.

Adjust the patellar resection level to the desired height by turning the smaller knob on top of the resection guide on the distal end of the patellar clamp.

NoteEnsure that the saw blade does not drift e.g. due to sclerotic bone sectors during the resection.

4.2 Patellar sizing

Determine the diameter of the appropriate patellar size using the patellar sizer.

NoteThe patellar component is implanted with a slight medial offset, thus matching the position of the natural patellar ridge. Small implant sizes are recommended for small patellae to enable the required offset.

4. Patellar PreparationIf patella resurfacing is required either an “onlay” or “inlay” implantation technique can be performed.

Start with measuring the thickness of the patella. Based on the minimal required patella thickness choose the resection height. The residual patella thickness (bone) should not be less than 12mm.

Avoid overstuffing of the resurfaced patella.

44

4.3 Patella Milling

Mount the patellar bushing onto the patellar clamp with ratchet.

Select the patellar reamer to match the corresponding patella size. Depending on the selected anchoring technique, mill briefly (onlay technique) or countersink by 3 to 5mm (inlay technique). Milling down to the stop results in a depth of 5mm.

NotePatellar components with a height of 10mm are recommended as standard. Implants with a height of 8mm are available as an alternative for thin patellae.

4.4 Drill anchoring holes

Using the patellar drill guide and the patellar peg stop drill, prepare the anchoring holes for the pegs.

4.5 Trial insertion and reduction

Insert the patellar trial. Check the fit of all components and perform a trial reduction to control knee stability, tibio-femoral rotation and patellar tracking.

4. Patellar Preparation

45

5.1 Tibial and femoral implantation

Clean, irrigate and dry the bone bed sufficiently.

5.2 A Implantation of cemented femoral

and tibial implants

The femoral / tibial holder (optional instrument) is used to position the femoral and tibial components (implants). Click the femoral or tibial holder insert onto the femoral / tibial holder. Assemble the femoral / tibial holder and the modular handle. Mount the femoral or tibial component onto the femoral / tibial holder by opening and then releasing the clamp. Use bone cement for the cemented implants only.

Implant the tibial component using the dedicated impactor in order to avoid surface damage.

Insert the femoral component. Avoid metal on metal contact (femur – tibia baseplate)!

Remove all excess cement.

Place the final tibial (PE) insert onto the tibia component and secure it with an audible click.

5. Implantation of Implant ComponentsThis section describes the steps how to implant the cemented and non-cemented femoral and tibial implants, the cemented patellar implant and how to insert the tibial insert.

During cementing the use of a tourniquet is recommended.

WarningUse only the dedicated impactors for hammering in the components. Avoid damaging the surfaces. Place the impactor block centrally on the component and align it parallel to the mechanical axis.

If an insert has been removed from the tibial component or has tilted when slid into place, visually check the insert for signs of damage before reuse. Do not reuse if damaged.

46

5.2 A Implantation of cemented femoral and tibial implants (continued)

Tighten the fixation screw in the PE insert by using the torque controlled screw driver.

Increase the applied torque until the mark “Insert” is achieved (= orange marked level).

5.2 B Implantation of non-cemented (porous) implant components (CR/CS)

Cancellous bone screws in different lengths are available (optional) for non-cemented fixation of the tibial component.

If screws are used, the corresponding polyethylene plugs must be removed from the tibial component by pushing them out from the distal side.

Implant the tibial component using the dedicated impactor in order to avoid surface damage.

For the anchorage of the porous coated tibial component, predrill the anchoring holes for the cancellous bone screws with a Ø 3.2mm drill. Insert the cancellous bone screws and final tibial insert.

Insert the femoral component. Avoid metal on metal contact (femur – tibia baseplate).

Place the final PE insert onto the tibia baseplate and secure it with an audibly click.

Tighten the fixation screw in the PE insert by using the torque controlled screw driver.

5. Implantation of Implant Components

47

5.3 Implantation of the patellar component

Mount the patellar inserter on the patellar clamp with ratchet.

Cement the patella component by pressing it onto the patella using the dedicated clamp.

Leave the clamp in place until the cement has completely set.

6. Wound Closure

Perform the wound closure in a regular manner.

5. Implantation of Implant Components

6. Wound Closure

48

Sterilization

Implants

All the implants described in this Surgical Technique are sterile when they are delivered by the manufacturer. Implants must never be re-sterilized.

Instruments

Instruments are not sterile when they are delivered. Before use they must be cleaned by the usual methods in accordance with internal hospital regulations and sterilized in an autoclave in accordance with the legal regulations and guidelines applicable in the relevant country. (For detailed information please refer to leaflet (document no. 03389.)

The applicable settings should be verified by the user in accordance with the instructions for use issued by the autoclave manufacturer.

Instrument manufacturers and dealers accept no responsibility for sterilization of products by the customer.

49

References

1 J Arthroplasty. 2007 Feb;22(2):235-40. The clinical consequences of flexion gap asymmetry in total knee arthroplasty. Romero J, Stähelin T, Binkert C, Pfirrmann C, Hodler J, Kessler O.

2 J Biomech. 2008 Dec 5;41(16):3332-9. doi: 10.1016/j.jbiomech.2008.09.032. Epub 2008 Nov 18. The effect of femoral component malrotation on patellar biomechanics. Kessler O, Patil S, Colwell CW Jr, D'Lima DD.

3 Knee Surg Sports Traumatol Arthrosc. 2015 Jul 15. Patient-related factors influence stiffness of the soft tissue complex during intraoperative gap balancing in cruciate-retaining total knee arthroplasty. Heesterbeek PJ1, Haffner N, Wymenga AB, Stifter J, Ritschl P.

4 J Bone Joint Surg Am. 1986 Sep;68(7):1041-51. The effect of conformity, thickness, and material on stresses in ultra-high molecular weight components for total joint replacement. Bartel DL, Bicknell VL, Wright TM.

5 Clin Orthop Relat Res. 1991 Aug;(269):78-88. Total knee arthroplasty. Two- to four-year experience using an asymmetric tibial tray and a deep trochlear-grooved femoral component. Hofmann AA1, Murdock LE, Wyatt RW, Alpert JP.

6 Orthopädische Praxis 41, 12 (2005): 663-667. Mittelfristige Ergebnisse nach zementlosem bikondylärem Kniegelenkersatz mit TC-PLUS. Gross R, Perner K, Pölzl A, Rattinger H.

7 Orthopädische Praxis 3 (2005): 141-146. Die Komponentenausrichtung beim Oberflächenersatz des Kniegelenkes. Malzer U, Schuler P

50

Appendix AAssembly of ligament tensioner – 6 steps

Mount the Tibia Plateau into the slot (1) and fix it with the screw driver (2)

Check if the orientation is correct (LEFT/RIGHT)

Mount the Stylus straight MIS for the medial femur condyle (3) and fix it with the screw driver (2).

Mount the Stylus curved MIS for the lateral femur condyle (5) and fix it with the screw driver (2).

Please consider that the marking “LEFT/RIGHT” on the Tibia Plateau & Stylus refer to the operating side (left or right knee).

The lateral support plate is more extensively curved in order to avoid a conflict with the patella.

12

2

3

2

5

51

Appendix BTC-PLUS™ Advanced Instrument Program

Instrument Case

Femoral Instruments – Standard .................................................. 52Femoral Instruments – Optional .................................................. 52

Tibial Instruments – Standard .....................................................54Tibial Instruments – Optional ...................................................... 55 Femoral Trials – Standard ............................................................ 56Femoral Trials – Optional ............................................................. 56

Trial Inserts CR – Standard .......................................................... 58Trial Inserts CR – Optional ............................................................ 58

Trial Inserts CS – Standard ..........................................................60Trial Inserts CS – Optional ...........................................................60

Trial Inserts PS – Standard ........................................................... 62Trial Inserts PS – Optional ............................................................ 62

Patellar Instruments – Standard ...................................................64Patellar Instruments – Optional ....................................................64

Ligament tensioner – Standard ................................................... 66Ligament tensioner – Optional .................................................... 66

Basic Instrument Cases

Basic

Implant Specific Instrument Cases

CR CS PS

52

Femoral Instruments – Standard Case Set No. 75210376 SAP No Art No Description Size Ø (mm) length/ Qty thickness 1 75102282 75102282 Case Femoral Instr, empty - - - 12 75007661 990019 Easy Tray Lid Plastic - - - 13 75004842 22000120 IM Rod with T-Handle - - - 14 75005039 22000333 Femoral Cutting Block 4 - 1.27 1 75005040 22000334 Femoral Cutting Block 6 - 1.27 1 75005041 22000335 Femoral Cutting Block 8 - 1.27 1 75005042 22000336 Femoral Cutting Block 10 - 1.27 15 75005045 22000352 Femoral Cutting Block Distal - 1.27 16 75005051 22000358 Inserter Femoral Cutting Block - - 17 75005076 22000415 Adapter to Modular Handle SW 3.5 - 18 75005420 240391 Pin Extractor - - - 19 75005659 251065 Drill - Ø 3.2 - 2 75102310 75102310 Preparation Drill Ø 8 - 1 75006493 42000096 Femoral Suspension Device - - - 1 75006496 42000099 Resection Stylus, 1.27mm - - 1.27mm 1 75007135 600172 Axial Alignment Rod ( I / II ) - - - 1 75006463 42000060 Instrument Tray Speed Pin - - - 1 75007138 600177 Bone Pin with Head - Ø 3.2 25 4 75007139 600178 Bone Pin with Head - Ø 3.2 38 4 75007140 600179 Bone Pin - Ø 3.2 75 4 75007141 600180 Bone Pin - Ø 3.2 100 4 75007142 600181 Slap Hammer - - - 1 75007145 600184 Femoral Bushing 6° - - 1 75007146 600185 Femoral Bushing 4° - - 1 75007147 600186 Femoral Bushing 8° - - 1 75007150 600189 Adapter for Slap Hammer - - - 1 75007202 600300 Modular Handle - - - 1

75102303 or 75102303 or Femoral Sizer (I/II) - - - 1 75005024 22000315 Femoral Sizer

75005031 22000324 Reduction Insert - - - 1 75102305 75102305 AP Correction Block - - - 1

Femoral Instruments – Optional Case Set No. 75210373

SAP No Movex SAP Size or diameter length Qty No Description type (mm) or thickness 4 75005038 22000332 Femoral Cutting Block 2 - 1.27 1 75005043 22000337 Femoral Cutting Block 12 - 1.27 1 75005049 22000356 Femoral Bushing 5° - - 1 75005050 22000357 Femoral Bushing 7° - - 1

75005850 252003 Femoral Holder Insert - - - 1 75006488 42000090 Instrument Handle - - - 1 75102304 75102304 Fem Distal Cut. Block adjust. - - - 1 75102307 or 75102307 or Femoral / Tibial Holder - - - 1

75005849 252002 Femoral / Tibial Holder 75005044 22000338 Femoral Cutting Controll Guide - - 1.27 1 75102306 75102306 Flexion Gap Spacer adjust. - - - 1

Femoral Instruments

53

1 2

3

4

5

6

7

8

9

❿

❿

❿

❿

❿

❿

❿

❿

❿

❿

❿

54

Tibial Instruments – Standard Case Set No. 75210399 SAP No Movex SAP Size or diameter length Qty No Description type (mm) or thickness 1 75102283 75102283 Case Tibial Instr, empty - - - 12 75007661 990019 Easy Tray Lid Plastic - - - 13 75000892 22000339 Tibia Spacer TC - - 9 1 75000893 22000340 Tibia Spacer TC - - 11 1 75000894 22000341 Tibia Spacer TC - - 13 1 75000895 22000342 Tibia Spacer TC - - 15 1 75000896 22000343 Tibia Spacer TC - - 17 1 75000897 22000344 Tibia Spacer TC - - 19 14 75000902 22000350 Femoral Spacer - - - 15 75004876 22000157 Guide Tube - - - 16 75004877 22000158 Ankle Fork ML - - - 17 75004879 22000161 Tibial Sizer Left 4 - - 1 75004880 22000162 Tibial Sizer Left 6 - - 1 75004881 22000163 Tibial Sizer Left 8 - - 1 75004882 22000164 Tibial Sizer Left 10 - - 18 75004885 22000168 Tibial Sizer Right 4 - - 1 75004886 22000169 Tibial Sizer Right 6 - - 1 75004887 22000170 Tibial Sizer Right 8 - - 1 75004888 22000171 Tibial Sizer Right 10 - - 19 75005023 22000314 Tibial Cutting Block - - 1.27 1 75005032 22000325 External Alignment Tower - - - 1 75005693 251145 Tibial Resection Guide Proximal - - - 1 75005695 251153 Tibial Rasp 2-4-6 2-4-6 - - 1 75005696 251154 Tibial Rasp 8-10-12 8-10-12 - - 1 75005697 251158 Tibial Stem Drill - Ø 14.6 - 1 75006489 42000092 Tibial Stylus - - - 1 75007137 600175 Tibial Sizer Handle - - - 1 75007188 600279 Adapter with Spherical Hex Head SW3.5 - - 2 75100757 75100757 Tibial Trial Insert Base Plate 4 - 6 1 75100758 75100758 Tibial Trial Insert Base Plate 6 - 6 1 75100759 75100759 Tibial Trial Insert Base Plate 8 - 6 1 75100760 75100760 Tibial Trial Insert Base Plate 10 - 6 1 75102308 75102308 Screwdriver - Torque - - - 1

Tibial Instruments

55

Tibial Instruments – Optional Case Set No. 75210397

SAP No Movex SAP Size or diameter length Qty No Description type (mm) or thickness 7 75004878 22000160 Tibial Sizer Left 2 - - 1 75004883 22000165 Tibial Sizer Left 12 - - 18 75004884 22000167 Tibial Sizer Right 2 - - 1 75004889 22000172 Tibial Sizer Right 12 - - 1 75005022 22000313 IM Tibial Resection Guide - - - 1 75005025 22000316 Correction Cutting Block (var/val) - - 1.27 1

75005690 251136 Drill Guide for Bone Screw - - - 1 75005851 252004 Tibial Holder Insert - - - 1 75005862 252139 Tibia Retractor - - - 1 75017159 22000422 Tibial Stylus adjustable - - - 1 75018727 22000463 Tibial Cutting Block adjustable - - 1.27 1

75100756 75100756 Tibial Trial Insert Baseplate 2 - 6 1 75100761 75100761 Tibial Trial Insert Baseplate 12 - 6 1

1

2

34

5

6

7

8

9

❿

❿

❿

❿❿

❿

❿

❿

❿

❿

❿

❿

❿

56

Femoral Trials – Standard Case Set No. 75210381 SAP No Movex SAP Size or diameter length Qty No Description type (mm) or thickness 1 75102290 75102290 Case Fem Trials, empty - - - 12 75007661 990019 Easy Tray Lid Plastic - - - 13 75002999 1214244 Drill with Stop - 6.3 - 14 75004845 22000123 Bolt für Femoral Trial - - - 25 75007130 600161 Trochlear Chisel - - - 16 75007169 600238 Curved Osteotome - - - 17 75007190 600288 Impactor Sizes 2-4-6 2-4-6 - - 1 75007191 600289 Impactor Sizes 8-10-12 8-10-12 - - 18 75100716 75100716 Femoral Trial Right 4 / 4S - - 1 75100717 75100717 Femoral Trial Right 6 / 6S - - 1 75100718 75100718 Femoral Trial Right 8 / 8S - - 1 75100719 75100719 Femoral Trial Right 10 - - 19 75100723 75100723 Femoral Trial Left 4 / 4S - - 1 75100724 75100724 Femoral Trial Left 6 / 6S - - 1 75100725 75100725 Femoral Trial Left 8 / 8S - - 1 75100726 75100726 Femoral Trial Left 10 - - 1 75100820 75100820 CR/CS Trochlea Insert Trial 4 - - 1 75100821 75100821 CR/CS Trochlea Insert Trial 6 - - 1 75100822 75100822 CR/CS Trochlea Insert Trial 8 - - 1 75100823 75100823 CR/CS Trochlea Insert Trial 10 - - 1 Femoral Trials – Optional Case Set No. 75210378 SAP No Movex SAP Size or diameter length Qty No Description type (mm) or thickness 75005821 or 251745 or File - - - 1 75018114 FK510R File8 75100715 75100715 Femoral Trial Right 2 - - 1 75100720 75100720 Femoral Trial Right 12 - - 19 75100722 75100722 Femoral Trial Left 2 - - 1 75100727 75100727 Femoral Trial Left 12 - - 1 75100819 75100819 CR/CS Trochlea Insert Trial 2 - - 1 75100824 75100824 CR/CS Trochlea Insert Trial 12 - - 1 75102301 75102301 Sizing Template Fem slim R - - - 1 75102302 75102302 Sizing Template Fem slim L - - - 1

Femoral Trials

57

1 2

3

4

5

6

7 7

8 9

❿

❿

❿ ❿

58

Tibial Trial Inserts CR – Standard Case Set No. 75210367 SAP No Movex SAP Size or diameter length Qty No Description type (mm) or thickness 1 75102291 75102291 Case CR Instr, empty - - 12 75007665 990022 Easy Tray Lid Plastic Half - - 13 75102331 75102331 CR Tibial Trial Insert Modular 4 9 / 15 1 75102332 75102332 CR Tibial Trial Insert Modular 4 11 / 17 1 75102333 75102333 CR Tibial Trial Insert Modular 4 13 / 19 1 75102336 75102336 CR Tibial Trial Insert Modular 6 9 / 15 1 75102337 75102337 CR Tibial Trial Insert Modular 6 11 / 17 1 75102338 75102338 CR Tibial Trial Insert Modular 6 13 / 19 1 75102341 75102341 CR Tibial Trial Insert Modular 8 9 / 15 1 75102342 75102342 CR Tibial Trial Insert Modular 8 11 / 17 1 75102343 75102343 CR Tibial Trial Insert Modular 8 13 / 19 1 75102346 75102346 CR Tibial Trial Insert Modular 10 9 / 15 1 75102347 75102347 CR Tibial Trial Insert Modular 10 11 / 17 1 75102348 75102348 CR Tibial Trial Insert Modular 10 13 / 19 1 Tibial Trial Inserts CR – Optional Case Set No. 75210365 SAP No Movex SAP Size or diameter length Qty No Description type (mm) or thickness 3 75102326 75102326 CR Tibial Trial Insert Modular 2 9 / 15 1 75102327 75102327 CR Tibial Trial Insert Modular 2 11 / 17 1 75102328 75102328 CR Tibial Trial Insert Modular 2 13 / 19 14 75102329 75102329 CR Tibial Trial Insert 2/10 2 - 10 1 75102330 75102330 CR Tibial Trial Insert 2/12 2 - 12 1 75102334 75102334 CR Tibial Trial Insert 4/10 4 - 10 1 75102335 75102335 CR Tibial Trial Insert 4/12 4 - 12 1 75102339 75102339 CR Tibial Trial Insert 6/10 6 - 10 1 75102340 75102340 CR Tibial Trial Insert 6/12 6 - 12 1 75102344 75102344 CR Tibial Trial Insert 8/10 8 - 10 1 75102345 75102345 CR Tibial Trial Insert 8/12 8 - 12 1 75102349 75102349 CR Tibial Trial Insert 10/10 10 - 10 1 75102350 75102350 CR Tibial Trial Insert 10/12 10 - 12 1 75102351 75102351 CR Tibial Trial Insert Modular 12 9 / 15 1 75102352 75102352 CR Tibial Trial Insert Modular 12 11 / 17 1 75102353 75102353 CR Tibial Trial Insert Modular 12 13 / 19 1 75102354 75102354 CR Tibial Trial Insert 12/10 12 - 10 1 75102355 75102355 CR Tibial Trial Insert 12/12 12 - 12 1

Tibial Trial Inserts CR

59

1

2

3 3

3 3

3 3

3 3

3 3

3 3

3 3

3 3

3 3

4 4

4 4

4 4

4 4

4 4

4 4

60

Tibial Trial Inserts CS – Standard Case Set No. 75210371 SAP No Movex SAP Size or diameter length Qty No Description type (mm) or thickness 1 75102292 75102292 Case CS Instr, empty - - - 12 75007665 990022 Easy Tray Lid Plastic Half - - - 13 75102361 75102361 CS Tibial Trial Insert Modular 4 - 9 / 15 1 75102362 75102362 CS Tibial Trial Insert Modular 4 - 11 / 17 1 75102363 75102363 CS Tibial Trial Insert Modular 4 - 13 / 19 1 75102366 75102366 CS Tibial Trial Insert Modular 6 - 9 / 15 1 75102367 75102367 CS Tibial Trial Insert Modular 6 - 11 / 17 1 75102368 75102368 CS Tibial Trial Insert Modular 6 - 13 / 19 1 75102371 75102371 CS Tibial Trial Insert Modular 8 - 9 / 15 1 75102372 75102372 CS Tibial Trial Insert Modular 8 - 11 / 17 1 75102373 75102373 CS Tibial Trial Insert Modular 8 - 13 / 19 1 75102376 75102376 CS Tibial Trial Insert Modular 10 - 9 / 15 1 75102377 75102377 CS Tibial Trial Insert Modular 10 - 11 / 17 1 75102378 75102378 CS Tibial Trial Insert Modular 10 - 13 / 19 1 Tibial Trial Inserts CS – Optional Case Set No. 75210369 SAP No Movex SAP Size or diameter length Qty No Description type (mm) or thickness 3 75102356 75102356 CS Tibial Trial Insert Modular 2 - 9 / 15 1 75102357 75102357 CS Tibial Trial Insert Modular 2 - 11 / 17 1 75102358 75102358 CS Tibial Trial Insert Modular 2 - 13 / 19 14 75102359 75102359 CS Tibial Trial Insert 2 - 10 1 75102360 75102360 CS Tibial Trial Insert 2 - 12 1 75102364 75102364 CS Tibial Trial Insert 4 - 10 1 75102365 75102365 CS Tibial Trial Insert 4 - 12 1 75102369 75102369 CS Tibial Trial Insert 6 - 10 1 75102370 75102370 CS Tibial Trial Insert 6 - 12 1 75102374 75102374 CS Tibial Trial Insert 8 - 10 1 75102375 75102375 CS Tibial Trial Insert 8 - 12 1 75102379 75102379 CS Tibial Trial Insert 10 - 10 1 75102380 75102380 CS Tibial Trial Insert 10 - 12 1 75102381 75102381 CS Tibial Trial Insert Modular 12 - 9 / 15 1 75102382 75102382 CS Tibial Trial Insert Modular 12 - 11 / 17 1 75102383 75102383 CS Tibial Trial Insert Modular 12 - 13 / 19 1 75102384 75102384 CS Tibial Trial Insert 12 - 10 1 75102385 75102385 CS Tibial Trial Insert 12 - 12 1

Tibial Trial Inserts CS

61

1

2

3

3

3

3

3

3

3

3

3

3

3

3

3

3

3

3

3

3

4

4

4

4

4

4

4

4

4

4

4

4

62

Tibial Trial Inserts PS – Standard Case Set No. 75210391 SAP No Movex SAP Size or diameter length Qty No Description type (mm) or thickness 1 75102293 75102293 Case PS Instr, empty - - - 12 75007661 990019 Easy Tray Lid Plastic - - - 13 75100734 75100734 PS Tibial Trial Insert Modular 4 - 9 / 15 1 75100735 75100735 PS Tibial Trial Insert Modular 4 - 11 / 17 1 75100736 75100736 PS Tibial Trial Insert Modular 4 - 13 / 19 1 75100737 75100737 PS Tibial Trial Insert Modular 6 - 9 / 15 1 75100738 75100738 PS Tibial Trial Insert Modular 6 - 11 / 17 1 75100739 75100739 PS Tibial Trial Insert Modular 6 - 13 / 19 1 75100740 75100740 PS Tibial Trial Insert Modular 8 - 9 / 15 1 75100741 75100741 PS Tibial Trial Insert Modular 8 - 11 / 17 1 75100742 75100742 PS Tibial Trial Insert Modular 8 - 13 / 19 1 75100743 75100743 PS Tibial Trial Insert Modular 10 - 9 / 15 1 75100744 75100744 PS Tibial Trial Insert Modular 10 - 11 / 17 1 75100745 75100745 PS Tibial Trial Insert Modular 10 - 13 / 19 1 75100810 75100810 PS Box Preparation Guide - - - 15 75100813 75100813 PS Box Insert 4 - - 1 75100814 75100814 PS Box Insert 6 - - 1 75100815 75100815 PS Box Insert 8 - - 1 75100816 75100816 PS Box Insert 10 - - 16 75102309 75102309 PS Femoral Box Prep Chisel - - - 17 75102311 75102311 PS Box Prep Bushing 2 / 4 - - 1 75102312 75102312 PS Box Prep Bushing 6 / 8 - - 1 75102313 75102313 PS Box Prep Bushing 10 / 12 - - 1 Tibial Trial Inserts PS – Optional Case Set No. 75210389 SAP No Movex SAP Size or diameter length Qty No Description type (mm) or thickness 3 75100731 75100731 PS Tibial Trial Insert Modular 2 - 9 / 15 1 75100732 75100732 PS Tibial Trial Insert Modular 2 - 11 / 17 1 75100733 75100733 PS Tibial Trial Insert Modular 2 - 13 / 19 1 75100746 75100746 PS Tibial Trial Insert Modular 12 - 9 / 15 1 75100747 75100747 PS Tibial Trial Insert Modular 12 - 11 / 17 1 75100748 75100748 PS Tibial Trial Insert Modular 12 - 13 / 19 15 75100812 75100812 PS Box Insert 2 2 - - 1 75100817 75100817 PS Box Insert 12 12 - - 18 75102314 75102314 PS Tibial Trial Insert 2 - 10 1 75102315 75102315 PS Tibial Trial Insert 2 - 12 1 75102316 75102316 PS Tibial Trial Insert 4 - 10 1 75102317 75102317 PS Tibial Trial Insert 4 - 12 1 75102318 75102318 PS Tibial Trial Insert 6 - 10 1 75102319 75102319 PS Tibial Trial Insert 6 - 12 1 75102320 75102320 PS Tibial Trial Insert 8 - 10 1 75102321 75102321 PS Tibial Trial Insert 8 - 12 1 75102322 75102322 PS Tibial Trial Insert 10 - 10 1 75102323 75102323 PS Tibial Trial Insert 10 - 12 1 75102324 75102324 PS Tibial Trial Insert 12 - 10 1 75102325 75102325 PS Tibial Trial Insert 12 - 12 19 75005857 252068 Quick Lock Handle - - - 2

Tibial Trial Inserts PS

63

1 2

3

3

3

3

3

3

3

3

3

3

3

3

4

5

6

7

9

8

8

8

8

8

8

8

8

8

8

8

8

3

3

3

3

3

3

64

Patellar Instruments – Standard Case Set No. 75210387 SAP No Movex SAP Size or diameter length Qty No Description type (mm) or thickness 1 75102295 75102295 Case Patellar Instr, empty - - - 12 75007661 990019 Easy Tray Lid Plastic - - - 13 75005034 22000327 Bone Thickness Sizer - - - 14 75005702 251204 Patellar Clamp Ratchet - - - 15 75005707 251230 Patellar Clamp Bushing - Ø 26 - 1 75005708 251231 Patellar Clamp Bushing - Ø 29 - 1 75005709 251232 Patellar Clamp Bushing - Ø 32 - 1 75005710 251233 Patellar Clamp Bushing - Ø 35 - 16 75005711 251240 Patellar Drill Guide - Ø 26 - 1 75005712 251241 Patellar Drill Guide - Ø 29 - 1 75005713 251242 Patellar Drill Guide - Ø 32 - 1 75005714 251243 Patellar Drill Guide - Ø 35 - 17 75005717 251278 Patellar Drill with Stop - Ø 5.5 - 18 75005716 251277 Patellar Inserter - - - 19 75005719 251282 Patellar Sizer - - - 1 75005706 251216 Patellar Mill with Stop - Ø 26 - 1 75005720 251283 Patellar Mill with Stop - Ø 29 - 1 75005721 251284 Patellar Mill with Stop - Ø 32 - 1 75005722 251285 Patellar Mill with Stop - Ø 35 - 1 75005723 251292 Patellar Trial - Ø 26 10 1 75005724 251293 Patellar Trial - Ø 29 10 1 75005725 251294 Patellar Trial - Ø 32 10 1 75005726 251295 Patellar Trial - Ø 35 10 1 75006490 42000093 Patella Cutting Guide MIS 1.27mm - - 1.27 1 Patellar Instruments – Optional Case Set No. 75210386 SAP No Movex SAP Size or diameter length Qty No Description type (mm) or thickness 75004871 22000152 Patellar Drill with Stop - 5.5 - 1 75004989 22000280 Patellar Mill with Stop (AO) - Ø 26 - 1 75004990 22000281 Patellar Mill with Stop (AO) - Ø 29 - 1 75004991 22000282 Patellar Mill with Stop (AO) - Ø 32 - 1 75004992 22000283 Patellar Mill with Stop (AO) - Ø 35 - 1 75005703 251209 Patellar Trial - Ø 26 8 1 75005704 251210 Patellar Trial - Ø 29 8 1 75005705 251211 Patellar Trial - Ø 32 8 1 75005881 252203 Patellar Clamp Cutting Guide - - 1.00 1 75005882 252221 Bone Thickness Sizer - 1

Patellar Instruments

65

1 2

3

4

5

6

7

8

9

❿

❿

❿

❿

❿

❿

❿

❿

66

Ligament tensioner – Standard Case Set No. 75210384 SAP No Movex SAP Size or diameter length Qty No Description type (mm) or thickness 1 75102296 75102296 Case Lig Tension. Instr, empty - - - 12 75007665 990022 Easy Tray Lid Plastic Half - - - 13 75006443 42000039 Ligament Tensioner Modular TC - - - 14 75102429 or 75102429 or Stylus Straight MIS Left - - - 1 75006446 42000042 Stylus Straight MIS Left5 75102430 or 75102430 or Stylus Straight MIS Right - - - 1 75006447 42000043 or Stylus Straight MIS Right6 75102431 or 75102431 or Stylus Curved MIS Left - - - 1 75006448 42000044 Stylus Curved MIS Left7 75102432 or 75102432 or Stylus Curved MIS Right - - - 1 75006449 42000045 Stylus Curved MIS Right8 75006506 42000109 Tibia Plateau Left kpl - - - 19 75006507 42000110 Tibia Plateau Right kpl - - - 1 Ligament tensioner – Optional Case Set No. 75210383 SAP No Movex SAP Size or diameter length Qty No Description type (mm) or thickness 75099004 22000529 Alignment Guide LB - - - 1 75100212 22000526 Femur Sizer LB - - - 1

Ligament tensioner

67

1

2

3

4

5

6

7

8

9

❿

❿

❿

❿

❿

❿❿

68

Femoral components

Appendix CTC-PLUS™ Advanced Primary – Implants

Primary CR Non-Cemented (CoCr) SAP No. left SAP No. right Size7500-5642 7500-5636 27501-5340 7501-5335 4S7500-5643 7500-5637 47501-5341 7501-5338 6S7500-5644 7500-5638 67501-7166 7501-7164 8S7500-5645 7500-5639 87500-5646 7500-5640 107500-5647 7500-5641 12

Primary CR Cemented (CoCr) SAP No. left SAP No. right Size7500-4735 7500-4729 27501-4583 7501-4567 4S7500-4736 7500-4730 47501-4594 7501-4568 6S7500-4737 7500-4731 67501-7161 7501-7162 8S7500-4738 7500-4732 87500-4739 7500-4733 107500-4740 7500-4734 12

69

Patellar components

Cemented (UHMWPE)

SAP No. Ø Thickness (mm)7500-4784 26 87500-4787 26 107500-4785 29 87500-4788 29 107500-4786 32 87500-4789 32 107500-4790 35 10


70

Tibial components

Primary / fixed bearing Cemented (CoCr) SAP No. left SAP No. right Size7500-4762 7500-4753 27500-4769 7500-4754 47500-4776 7500-4755 67500-4780 7500-4756 87500-4781 7500-4757 107500-4782 7500-4758 12

Primary / fixed bearing Non-Cemented (CoCr) SAP No. left SAP No. right Size7500-5798 7500-5770 27500-5819 7500-5780 47500-5835 7500-5781 67500-5841 7500-5782 87500-5842 7500-5783 107500-5843 7500-5784 12


71

Tibial components

Primary / mobile bearing* Cemented (CoCr) SAP No. left = right Size7500-4747 27500-4748 47500-4749 67500-4750 87500-4751 107500-4752 12

Primary / mobile bearing* Non-Cemented (CoCr) SAP No. left = right Size7500-5844 27500-5845 47500-5846 67500-5847 87500-5848 107500-5853 12


* Surgical Technique for mobile bearing implants: Final Trial Reduction and Component Implantation (Lit. No 1703-e).

72

Tibial inserts – fixed bearing

Cruciate Retaining CR (UHMWPE) SAP No. SAP No. SAP No. SAP No SAP No. SAP No. Thick- Size 2 Size 4 Size 6 Size 8 Size 10 Size 12 ness7500-5915 7500-5946 7500-5993 7500-6031 7500-6043 7500-6048 9mm7500-5916 7500-5955 7500-5997 7500-6039 7500-6044 7500-6049 11mm7500-5917 7500-5964 7500-6002 7500-6040 7500-6045 7500-6050 13mm7500-5918 7500-5973 7500-6008 7500-6041 7500-6046 7500-6051 15mm7500-6054 7500-6055 7500-6056 7500-6057 7500-6058 7500-6053 17mm7500-5919 7500-5982 7500-6014 7500-6042 7500-6047 7500-6052 19mm

Cruciate Substituting CS (UHMWPE) SAP No. SAP No. SAP No. SAP No SAP No. SAP No. Thick- Size 2 Size 4 Size 6 Size 8 Size 10 Size 12 ness7500-6065 7500-6070 7500-6075 7500-6080 7500-6085 7500-6090 9mm7500-6066 7500-6071 7500-6076 7500-6081 7500-6086 7500-6091 11mm7500-6067 7500-6072 7500-6077 7500-6082 7500-6087 7500-6092 13mm7500-6059 7500-6060 7500-6061 7500-6062 7500-6063 7500-6064 15mm7500-6069 7500-6074 7500-6079 7500-6084 7500-6089 7500-6094 17mm7500-6068 7500-6073 7500-6078 7500-6083 7500-6088 7500-6093 19mm


73

Tibial inserts – fixed bearing


Sliding bearing SB (UHMWPE) SAP No. SAP No. SAP No. SAP No SAP No. SAP No. Thick- Size 2 Size 4 Size 6 Size 8 Size 10 Size 12 ness7500-6105 7500-6109 7500-6115 7500-6121 7500-6127 7500-6133 9mm7500-6106 7500-6110 7500-6116 7500-6122 7500-6128 7500-6134 11mm7500-6107 7500-6111 7500-6117 7500-6123 7500-6129 7500-6135 13mm7500-6108 7500-6112 7500-6118 7500-6124 7500-6130 7500-6136 15mm7501-7337 7500-6113 7500-6119 7500-6125 7500-6131 7501-7339 17mm7501-7338 7500-6114 7500-6120 7500-6126 7500-6132 7501-7340 19mm

Tibial inserts – mobile bearing

* Surgical Technique for mobile bearing implants: Final Trial Reduction and Component Implantation (Lit. No 1703-e).

Posterior stabilized PS (UHMWPE) SAP No. SAP No. SAP No. SAP No SAP No. SAP No. Thick- Size 2 Size 4 Size 6 Size 8 Size 10 Size 12 ness7510-0599 7510-0592 7510-0585 7510-0578 7510-0613 7510-0606 9mm7510-0600 7510-0593 7510-0586 7510-0579 7510-0614 7510-0607 11mm7510-0601 7510-0594 7510-0587 7510-0580 7510-0615 7510-0608 13mm7510-0602 7510-0595 7510-0588 7510-0581 7510-0616 7510-0609 15mm 7510-0596 7510-0589 7510-0582 7510-0617 7510-0610 17mm

74

Appendix DTC-PLUS™ Advanced X-Ray Templates

TC-PLUS Advanced PS - Nr. 05047

TC-PLUS Advanced CR/CS - Nr. 05048

TC-PLUS Advanced SB - Nr. 05049

75

Appendix ETC-PLUS™ Advanced – Sawblades and Speedpins Portfolio

It is recommend to use the following Speedpins in combination with TC-PLUS Advanced Primary Instruments (No. 1450-e.)

If standard pins are used it is recommended to pre-drill the holes to prevent undesired lift-off or shift of cutting blocks or trial components.

Seedpins are available in different lengths and types:

Speedpin with Rim (30 mm)

SAP. No. 75006487

Speedpin (65mm, 80mm, 110mm)

SAP. No. 75009338 PAC Speed-Pins 3.2, 65 mm (6x)

75009339 PAC Speed-Pins 3.2, 80 mm (6x)

75009340 PAC Speed-Pins 3.2, 110 mm (6x)

AO adapter for Speedpins

SAP. No. 75009310

For detailed instructions, please refer to “Surgical Technique PiGalileo Speedpin System, Use of Speedpin and Adapter”, Document No. 1450-e.

It is recommend to use the following Sawblades in combination with TC-PLUS Advance Primary Instruments (No. 01218)

DistributorSmith & Nephew Orthopaedics AGOberneuhofstrasse 10d6340 BaarSwitzerland

ManufacturerKOMET MEDICALGEBR. BRASSELER GmbH & Co. KG

Lit. No. 01218-en Ed. 11/13

* Only available in older KMS-Version

1319

1,27

1,27

Sawblade Portfolio

Thickness [mm] Synthes/Zimmer Aesculap old Aesculap 3Ti Linvatec Hall Stryker de Soutter MicroAir Width [mm]

75100950 75100952 75102010 54780030 54780051 75102435 75102444

75101992 75102009 75102011 54780031 54780052 75102436 75102445

76

Appendix FTC-PLUS™ Advanced Primary Instrument Program –Maintenance and verification of instruments with a measuring function

The Femoral Sizer (Fig. F01.1) is maintenance free. This instrument is checked and verified at S&N’s internal final inspection regarding accuracy of angles, distances and scale, prior to delivery to the customer.

However, check the accuracy/functionality of the Femoral Sizer prior to use, as followed:

1. Assemble both parts of the Femoral Sizer (Fig. F01.1)

2. Set all scales of part I/II in neutral position "0".

3. Measure the height of the Impactor small (75007190/600288) or Impactor large (75007191/600289) as shown in (Fig. F01.2)

4. Check: Read the size. It must be at “4”. If it deviates (> 0.5mm) return the instrument to S&N for maintenance and repair service. (Fig F01.3)

F01. Femoral sizer (75102303/75102303) or (75005024/22000315)

Fig. F01.2

Fig. F01.1

Fig. F01.3

In the following Appendix F the maintenance and verification of instruments with a measuring function is described. Prior to the clinical application of the instruments the following control steps for each specific instrument with a measuring function has to be performed as followed:

77


F02. Screwdriver – Torque (75102308/75102308)

The Screwdriver – Torque (Fig. F02.1) is maintenance free. This instrument is checked and verified at S&N’s internal final inspection regarding accuracy of the scale and hence the applied torque, prior to delivery to the customer.

However, check the accuracy/functionality of the Screwdriver – Torque prior to use, as followed:

Check if the marking is at position “0” (Fig. F02.2) while no torque is applied.

If the marking lines deviate (> 0.3mm) return the instrument to S&N for maintenance and repair service.

Fig. F02.1

Fig. F02.2

78


F03. Ligament Tensioner Modular TC (75006443/42000039)

The Ligament Tensioner (Fig. F03.1) is maintenance free. This instrument is checked and verified at S&N’s internal final inspection regarding accuracy of the scales and hence of the angle in (°], the applied load in [N] and the measured gap distance [mm] prior to delivery to the customer.

However, check the accuracy/functionality of the Ligament Tensioner prior to use, as followed:

Check if the markings indicating applied force, gap distance and angle are at the level of the “calibration lines” (marked with “C”, Fig. F03.2) while no force is applied and the paddles/stylus are not expanded.

If the marking lines deviate from calibration lines, return the instrument to S&N for maintenance and repair service.

Accuracy:

Distance: ±0.5mmForce: ±15NAngle: ±1°

Fig. F03.2

Fig. F03.1

79


F04. Bone Thickness Sizer (75005034/22000327)

The Bone Thickness Sizer (Fig. F04.1) is maintenance free. This instrument is checked and verified at S&N’s internal final inspection regarding accuracy of the scale to measure bone thickness, prior to delivery to the customer.

However, check the accuracy/functionality of the Bone Thickness Sizer prior to use, as followed:

Check if the marking is at position “0” when the instrument is closed (which corresponds to 0mm bone thickness)

If the marking deviates from “0” position, return the instrument to S&N for maintenance and repair service.

F05. Bone Thickness Sizer (optional) (75005882/252221)

The Bone Thickness Sizer (Fig. F05.1) is maintenance free. This instrument is checked and verified at S&N’s internal final inspection regarding accuracy of the scale to measure bone thickness, prior to delivery to the customer.

However, check the accuracy/functionality of the Bone Thickness Sizer prior to use, as followed:

Check if the marking is at position “0” when the instrument is closed (which corresponds to 0mm bone thickness)

If the marking deviates from “0” position, return the instrument to S&N for maintenance and repair service.

Accuracy: ±1mm

Accuracy: ±2mm

Fig. F05.1

Fig. F04.1

80


F06. Patellar Clamp Ratchet (75005702/251204)

The Patellar Clamp Ratchet (Fig. F06.1) is maintenance free. This instrument is checked and verified at S&N’s internal final inspection regarding accuracy of distances and scales, prior to delivery to the customer.

Fig. F06.1

Accuracy: ±1mm

81

Notes

Manufacturer ContactSmith & Nephew Orthopaedics AGOberneuhofstrasse 10d6340 BaarSwitzerland

™Trademark of Smith & Nephew 04902-en V2 12/18300 Ex. 11/07 0123

surgical technique *smith&nephew tc-plus™advanced...smith & nephew tc-plus advanced knee...

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