indications & contraindications...11 compactor try-in 01 00-n 12 extractor sca-ic 08 00-n 13...
TRANSCRIPT
INDICATIONS & CONTRAINDICATIONS
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INDICATIONS
Indicated in following pathologies between C3 to C7:
-Cervical hernia
-Cervicarthrosis
-Degenerative disc disease
-Traumatology
CONTAINDICATIONS
Mental illness Infection Severely damaged bone structures that could prevent stable implantation of the cage Neuromuscular or vascular disorders or illness Inadequate activity Pregnancy Bone tumor in the region of implant Fractures
The screws allow a better stabilization of the device Anti back-out system The screws are secured:
• The screw head is micro-threaded • The screw head has a conical shape • 1,3 Nm torque tightening
AVOID ANY RISK OF EXPULSION ONCE LOCKED INTO THE CAGE
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FEATURES & BENEFITS: Secured cage
FEATURES & BENEFITS: Zero-profile implant
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The screw heads are completely integrated in the cage
REDUCE POTENTIAL RISKS ASSOCIATED TO DYSPHAGIA LIMIT OSSSIFICATION RISKS OF ADJACENT LEVELS
FEATURES & BENEFITS: Simplicity of use
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The SCARLET®AC-T system combines the functionality of a cage together with the advantages of a cervical plate. The cage is also available with a lordotic profile (Q1 2015). EASY INSERTION AND A PERFECT ADAPTATION BETWEEN THE ENDPLATES GIVE ADDITIONAL OPTION TO RESTORE THE SAGITTAL BALANCE
FEATURES & BENEFITS: Titanium
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Single-piece Titanium cage. Teeth on both faces of the cage. Sand-blasted layers increase surface roughness. LARGE GRAFT WINDOW INCREASED PRIMARY STABILITY PROMOTE OSSEOINTEGRATION
WHY TITANIUM ?
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SCARLET®AC-T
MATERIAL PROPERTIES:
-Promote primary stability
- Long term osseo integration
MARKETS NEEDS: - Some major markets believe in Titanium technologies - Global market trends
SPINEART PORTFOLIO: - Completes existing PEEK platform with new Ti technologies
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WHY TITANIUM?
6 heights from 5mm to 10mm are available to adapt to various interbody spaces
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RANGE: Cage
H5 H6 H7 H8 H9 H10
ANATOMICAL SHAPE
LORDOTIC PROFILE
CAGE FOOTPRINT HEIGHT ANTERIOR HEIGHT MEDIAL HEIGHT POSTERIOR HEIGHT
CONVEXE
SMALL
H05 5 5,2 3.88
H06 5,6 6 4.68
H07 6,6 7 5.68
H08 7,6 8 6.68
H09 8,6 9 7.68
H10 9,6 10 8.68
LARGE
H05 5 5,2 3.46
H06 5,6 6 4.26
H07 6,6 7 5.26
H08 7,6 8 6.26
H09 8,6 9 7.26
H10 9,6 10 8.26
ANTERIOR
HEIGHT
POSTERIOR
HEIGHT
MEDIAL HEIGHT
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RANGE: Anatomical Cage
RANGE: Lordotic Cage
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CAGE FOOTPRINT HEIGHT ANTERIOR HEIGHT POSTERIOR HEIGHT
LORDOTIC
SMALL
H05 5,2 4,17
H06 6 4,48
H07 7 5,48
H08 8 6,48
H09 9 7,48
H10 10 8,48
LARGE
H05 5,2 3,95
H06 6 4,24
H07 7 5,24
H08 8 6,24
H09 9 7,24
H10 10 8,24
POSTERIOR
HEIGHT ANTERIOR
HEIGHT
2 DIFFERENT FOOTPRINTS
Anatomical and lordotic cages are available in two footprints
PERFECT ADAPTATION BETWEEN THE ENDPLATES
12mm
15mm
14mm
17mm
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RANGE: Cage
CAGE FOOTPRINT HEIGHT SURFACE INF SURFACE SUP SURFACE x2 MM² VOLUME CM³
ANATOMICAL
SMALL
H05 44.396 44.58 88.976 0.251
H06 44.396 43.865 88.261 0.295
H07 44.396 43.865 88.261 0.353
H08 44.396 43.865 88.261 0.411
H09 44.396 43.865 88.261 0.469
H10 44.396 43.865 88.261 0.527
LARGE
H05 72.03 72.156 144.186 0.389
H06 72.03 71.479 143.509 0.455
H07 72.03 71.479 143.509 0.541
H08 72.03 71.479 143.509 0.627
H09 72.03 71.479 143.509 0.714
H10 72.03 71.479 143.509 0.800
LORDOTIC
SMALL
H05 45.556 44.697 90.253 0.240
H06 46.554 44.823 91.377 0.263
H07 46.554 44.823 91.377 0.321
H08 46.554 44.823 91.377 0.379
H09 46.554 44.823 91.377 0.437
H10 46.554 44.823 91.377 0.495
LARGE
H05 73.219 72.446 145.665 0.365
H06 74.154 72.574 146.728 0.398
H07 74.154 72.574 146.728 0.484
H08 74.154 72.574 146.728 0.571
H09 74.154 72.574 146.728 0.657
H10 74.154 72.574 146.728 0.743
RANGE: Cage
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L12 L14 L16 L18 Ø 3mm Ø 3,5mm
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Range: Screws
The screws are available in 4 lengths from 12mm to 18mm in 2 mm increment. 2 diameters are also available BEST FIT THE ANATOMY OF THE PATIENT REVISION
3.6
3.2
1.4
1.6
2.0 1.2
SMALL
CAGE
LARGE
CAGE
12mm
14mm
16mm
18mm
12mm
14mm
16mm
18mm
SMALL
CAGE
LARGE
CAGE
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Range: Screws
Range: Screws angulation
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INSTRUMENT SET
• Single compact dedicated set • Offers various options to surgeons • In line with Spineart philosophy:
• Simple • Easy to use
OUS COMPOSITION (1/2): UPPER TRAY
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1
2 3 4
5
OUS COMPOSITION (1/2): UPPER TRAY
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# DESCRIPTION REFERENCE
1 AO CONNECTION DYNAMOMETRIC HANDLE 1.3NM
HAN-SI DY 13-N
2 AO HANDLE HAN-SI AO 08-N
3 IMPLANT HOLDER TUBE SCA-IC 03 00-N
4 IMPLANT HOLDERS
SCA-IC 03 05-N SCA-IC 03 06-N SCA-IC 03 07-N SCA-IC 03 08-N SCA-IC 03 09-N SCA-IC 03 10-N
5 RASP TRIALS
SCA-IC 2S 05-N SCA-IC 2S 07-N SCA-IC 2S 09-N SCA-IC 2L 05-N SCA-IC 2L 07-N SCA-IC 2L 09-N
OUS COMPOSITION (2/2): LOWER TRAY
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6
7
8
9
10
11 12 13 14
OUS COMPOSITION (2/2): LOWER TRAY
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# DESCRIPTION REFERENCE
6 COMPACTION BASE SCA-IC 04 00-N
7 STRAIGHT SQUARE AWL SCA-IC 05 00-N
8 ANGLED SQUARE AWL SCA-IC 05 01-N
9 STRAIGHT SCREWDRIVER SCA-IC 06 00-N
10 ANGLED SCREWDRIVER SCA-IC 06 01-N
11 COMPACTOR TRY-IN 01 00-N
12 EXTRACTOR SCA-IC 08 00-N
13 STRAIGHT DRILL SCA-IC 09 00-N
14 ANGLED DRILL SCA-IC 10 00-N
LORDOTIC SMOOTH TRIAL
SCA-IC 3S 05-N SCA-IC 3S 07-N SCA-IC 3S 09-N SCA-IC 3L 05-N SCA-IC 3L 07-N SCA-IC 3L 09-N
OUS COMPOSITION: OPTIONAL INSTRUMENTS
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# DESCRIPTION REFERENCE
1 ARTICULATED CERVICAL DISTRACTOR CDP-IN 50 00-N
2 SCREWDRIVER FOR PINS CDP-IN 30 01-N
3 NUT FOR PINS CDP-IN 30 02-N
4 PINS
CDP-IN 30 12-N CDP-IN 30 14-N CDP-IN 30 16-N CDP-IN 30 18-N CDP-IN 40 12-N CDP-IN 40 14-N CDP-IN 40 16-N CDP-IN 40 18-N
5 DISPOSABLE PINS
SCA-IN 30 12-S SCA-IN 30 14-S SCA-IN 30 16-S SCA-IC 30 18-S SCA-IN 40 12-S SCA-IN 40 14-S SCA-IN 40 16-S SCA-IN 40 18-S
1 2 3 4 5
PATIENT POSITIONING Place the patient in a supine position on the operating table. A pillow can be positioned under the neck of the patient to preserve the lordosis.
SURGICAL TECHNIQUE
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SURGICAL TECHNIQUE
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DISTRACTION Place the pins parallel to the endplates. Once the pins are correctly placed, position the Articulated Cervical Distractor on the pins. Attach the nuts to the screwdriver for pins and secure Cervical Distractor on the pins.
Pins:
CDP-IN 30 12-N to CDP-IN 3018-N
Cervical Distractor:
CDP-IN 50 00-N
Nut for pins:
CDP-IN 30 02-N
Screwdriver for pins:
SCA-IC 07 00-N
PREPARATION OF THE ENDPLATES The Rasp Trials can be used to further prepare the endplates. A mallet can be used to gently advance the rasp trial. Note that the «depth stopper» on the rasp can be used for midline positioning.
SURGICAL TECHNIQUE
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Rasp Trials :
SCA-IC 2S 05-N to SCA-IC 2S 09-N
SCA-IC 2L 05-N to SCA-IC 2L 09-N
SELECTION OF THE IMPLANT SIZE Use the rasp trial to determine the height and footprint (depth and width) of the implant. The selection of the implant size depends on the intervertebral space, patient anatomy and preparation technique. The rasp trial must be placed in a correct cranio / caudal position centered as shown in the picture. A mallet can be used to gently insert the trial, note that the «depth stopper» on the rasp can be used for midline positioning. Perform an AP and Lateral control, release the distractor to verify the stability of the rasp trial implant.
SURGICAL TECHNIQUE
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Rasp Trials :
SCA-IC 2S 05-N to SCA-IC 2S 09-N
SCA-IC 2L 05-N to SCA-IC 2L 09-N
ASSEMBLY OF THE IMPLANT HOLDER Select the implant holder shaft according to the height previously selected. Assemble the implant holder tube on the implant holder shaft and turn the tube until it passes the first set of threads. Attach the AO handle to the implant holder shaft. To facilitate the assembly of the two elements ensure that the two arrows are correctly aligned. Pull and twist the handle to ensure it is fixed properly. Align the UP markings on the inserter with the top of the implant and attach the implant into the inserter. Turn the tube down towards the implant to lock it in place. Do not over tighten.
SURGICAL TECHNIQUE
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Implant Holder:
SCA-IC 03 05-N to SCA-IC 03 10-N
Implant Holder Tube :
SCA-IC 03 00-N
AO Connection Model 8 Handle :
HAN-SI AO 08-N
CAGE PREPARATION Place the cage on the compaction base and fill it with bone graft by using the compactor. Please note that the compaction base can also be used as a base for screws, to facilitate the connection between screws and self retaining screwdriver.
SURGICAL TECHNIQUE
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Compaction Base :
SCA-IC 04 00-N
Compactor :
TRY-IN 01 00-N
INSERTION Insert the implant in the intervertebral space. The implant inserter is equipped with a depth stop. Impact gently with a hammer if needed. Remove the Articulated Cervical Distractor and Pins. OPTION: Place a small amount of bone wax in the holes created by the Distractor Pins.
SURGICAL TECHNIQUE:
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Implant Holder:
SCA-IC 03 05-N to SCA-IC 03 10-N
Implant Holder Tube :
SCA-IC 03 00-N
AO Connection Model 8 Handle :
HAN-SI AO 08-N
PREPARATION OF THE FIRST SCREW SITE Prepare the insertion hole for the cervical screw in the superior vertebra by inserting the straight or angled square awl into the guide hole of the implant holder. Both square awls measure 14mm length. This helps estimate the final screw length with a lateral image control.
SURGICAL TECHNIQUE:
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Implant Holder:
SCA-IC 03 05-N to SCA-IC 03 10-N
Implant Holder Tube :
SCA-IC 03 00-N
AO Connection Model 8 Handle
HAN-SI AO 08-N
Straight square awl:
SCA-IC 05 00-N
FIRST SCREW INSERTION Assemble the selected screwdriver. While keeping in place the implant holder, insert the superior screw using the straight or angled screwdriver. Use AP and Lateral images to verify the implant position. It is necessary to create pilot holes prior to insert the SCARLET®AC-T. locking screws.
SURGICAL TECHNIQUE:
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Straight Screwdriver:
SCA-IC 06 00-N
Angled Screwdriver :
SCA-IC 06 01-N
Implant Holder:
SCA-IC 03 05-N to SCA-IC 03 10-N
Implant Holder Tube :
SCA-IC 03 00-N
AO Connection Model 8 Handle
HAN-SI AO 08-N
AO Connection Dynamometric
Handle 1,3 Nm :
HAN-SI AO 08-N
PREPARATION OF THE SECOND SCREW SITE Prepare the insertion hole of the screws in the inferior vertebra by inserting the bone awl in the guide holes on the implant holder.
SURGICAL TECHNIQUE:
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Implant Holder:
SCA-IC 03 05-N to SCA-IC 03 10-N
Implant Holder Tube :
SCA-IC 03 00-N
AO Connection Model 8 Handle
HAN-SI AO 08-N
Straight Square Awl:
SCA-IC 05 00-N
Angled Square Awl:
SCA-IC 05 01-N
SECOND SCREW INSERTION Insert the inferior screw using the straight or angled screwdriver. Verify implant placement with AP and lateral image.
SURGICAL TECHNIQUE:
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Implant Holder:
SCA-IC 03 05-N to SCA-IC 03 10-N
Implant Holder Tube :
SCA-IC 03 00-N
AO Connection Model 8 Handle
HAN-SI AO 08-N
Straight Screwdriver:
SCA-IC 06 00-N
Angled Screwdriver :
SCA-IC 06 01-N
AO Connection Dynamometric
Handle 1,3 Nm :
HAN-SI AO 08-N
FINAL REVISION In case of revision, remove both screws using the straight or angled screwdriver. Use the implant remover forceps to remove the implant. Gently pull the implant out of the vertebral space.
SURGICAL TECHNIQUE:
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AO Connection Model 8 Handle
HAN-SI AO 08-N
Straight Screwdriver:
SCA-IC 06 00-N
Angled Screwdriver :
SCA-IC 06 01-N
Extractor :
SCA-IC 08 00-N
No conflict risk between screws in multi-level situations No conflict risk with cervical distractor
Large graft window
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CASES
Hybrid construct with BAGUERA®C
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CASES
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MRI
SCARLET®AC-T VS MEDTRONIC PEEK PREVAIL
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• Only one footprint: No anatomical shape No lordotic option
• Needs endplates and anterior wall preparation • Only 5 heights • Screws are not self-locking (nitinol wire) • Conflict risk in multi level situation
SPINEART SCARLET AC-T
Medtronic PEEK Prevail
KEY
FEA
TUR
ES
MATERIAL Titanium PEEK + Nitinol
SELF LOCKING SCREWS YES NO
ANTI BACK-OUT SYSTEM INTEGRATED NITINOL WIRE
SELF TAPPING AND SELF DRILLING OPTION
YES YES
ZERO PROFILE YES NO
ANATOMICAL SHAPE YES NO
IMP
LAN
T C
HA
RA
CTE
RIS
TIC
S
NUMBER OF SCREWS 2 2
FOOTPRINTS 12 x 15 14 x 17
14x16
HEIGHTS 5 to 10
1mm increment 5 to 9
1mm increment
LORDOSIS Convex NO
SCARLET®AC-T VS SYNTHES ZERO PVA
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• The device is not 100% Titanium: What about wear debris ? What about assembly of the two parts?
• The cage is not zero-profile: Two spikes are more anterior than the anterior wall once the cage is positioned (+1,25mm vs anterior wall)
• Limited possibility of revision with only one screw diameter (Ø3.7mm)
• No torque limiter
SPINEART SCARLET AC-T
SYNTHES ZERO PVA
KEY
FEA
TUR
ES
MATERIAL Titanium PEEK + Titanium
SELF LOCKING SCREWS YES NO
ANTI BACK-OUT SYSTEM INTEGRATED STOP BUTTON
SELF TAPPING AND SELF DRILLING OPTION
YES SELF DRILLING
OR SELF TAPPING
ZERO PROFILE YES NO
ANATOMICAL SHAPE YES YES
IMP
LAN
T C
HA
RA
CTE
RIS
TIC
S
NUMBER OF SCREWS 2 2
FOOTPRINTS 12 x 15 14 x 17
15 x 13.6 17.5 x 16.6
HEIGHTS 5 to 10
1mm increment 5 to 12
1mm increment
LORDOSIS Convex Parallel, Convex, Lordotic
SPINEART SCARLET AC-T
SYNTHES ZERO P
KEY
FEA
TUR
ES
MATERIAL Titanium PEEK + Titanium
SELF LOCKING SCREWS YES YES
ANTI BACK-OUT SYSTEM INTEGRATED INTEGRATED
SELF TAPPING AND SELF DRILLING OPTION
YES NO
Self drilling only
ZERO PROFILE YES YES
ANATOMICAL SHAPE YES YES
IMP
LAN
T C
HA
RA
CTE
RIS
TIC
S
NUMBER OF SCREWS 2 4
FOOTPRINTS 12 x 15 14 x 17
13.5x17.5 16.5 x 17.5
HEIGHTS 5 to 10
1mm increment 5 to 12
1mm increment
LORDOSIS Convex Parallel, Convex, Lordotic
SCARLET®AC-T VS SYNTHES ZERO P
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• The device is not 100% Titanium: What about wear debris ? What about assembly of the two parts?
• Invasive device with 4 screws • Only one diameter of screws (Ø3mm). • Screw thread design
SCARLET®AC-T VS STRYKER AVS ANCHOR
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• The device is not 100% Titanium: What about wear debris? What about assembly of the PEEK and Titanium parts?
• No small heights for collapsed disc (no 5mm height) • No anatomical shape • No secured locking system
SPINEART SCARLET AC-T
Styker AVS Anchor
KEY
FEA
TUR
ES
MATERIAL Titanium PEEK + Titanium
SELF LOCKING SCREWS YES YES
ANTI BACK-OUT SYSTEM INTEGRATED INTEGRATED
SELF TAPPING AND SELF DRILLING OPTION
YES YES
ZERO PROFILE YES YES
ANATOMICAL SHAPE YES NO
Parallel
IMP
LAN
T C
HA
RA
CTE
RIS
TIC
S
NUMBER OF SCREWS 2 2
FOOTPRINTS 12 x 15 14 x 17
12 x 14 14 x 16
HEIGHTS 5 to 10
1mm increment 6 to 12
1mm increment
LORDOSIS Convex 0° / 4° / 8°
SCARLET®AC-T VS K2M CHESAPEAKE
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• 3 screws per implant. • Only one lordotic profile • Screws are not self-drilling • Conflict risks between screws and cervical distractor / in multi level situation
SPINEART SCARLET AC-T
K2M Chesapeake
KEY
FEA
TUR
ES
MATERIAL Titanium Titanium
SELF LOCKING SCREWS YES YES
ANTI BACK-OUT SYSTEM INTEGRATED INTEGRATED
SELF TAPPING AND SELF DRILLING OPTION
YES NO
Only self tapping
ZERO PROFILE YES YES
ANATOMICAL SHAPE YES NO
IMP
LAN
T C
HA
RA
CTE
RIS
TIC
S NUMBER OF SCREWS 2 3
FOOTPRINTS
12 x 15 14 x 17
12x17 13x18
HEIGHTS 5 to 10 1mm increment
5 to 10 1mm increment
LORDOSIS Convex 7°
SCARLET®AC-T VS GLOBUS COALITION
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• PEEK Cage with Titanium locking plate • Not zero profile Intrusive keels on the anterior part of the Titanium locking mechanism.
• The screws are not self-locking • No small heights for collapsed disc
SPINEART SCARLET AC-T
Globus Coalition
KEY
FEA
TUR
ES
MATERIAL Titanium PEEK + Titanium
SELF LOCKING SCREWS YES NO
ANTI BACK-OUT SYSTEM INTEGRATED PIVOTING STOP
SELF TAPPING AND SELF DRILLING OPTION
YES NO
ZERO PROFILE YES NO
ANATOMICAL SHAPE YES YES
IMP
LAN
T C
HA
RA
CTE
RIS
TIC
S
NUMBER OF SCREWS 2 2
FOOTPRINTS 12 x 15 14 x 17
12x14 14x16 15x18
HEIGHTS 5 to 10
1mm increment 6 to 12
1mm incremen
LORDOSIS Convex 0° or 7°
SCARLET®AC-T VS LDR ROI-C
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• PEEK Cage • Only 5 heights with 8mm as a maximum • Securing system with plates • Complex insertion of the blades
SPINEART SCARLET AC-T
LDR ROI C
KEY
FEA
TUR
ES
MATERIAL Titanium PEEK
SELF LOCKING SCREWS YES Only « plates »
ANTI BACK-OUT SYSTEM INTEGRATED /
SELF TAPPING AND SELF DRILLING OPTION YES NO
Only « Plates »
ZERO PROFILE YES YES
ANATOMICAL SHAPE YES YES
IMP
LAN
T C
HA
RA
CTE
RIS
TIC
S NUMBER OF SCREWS 2 0
FOOTPRINTS 12 x 15 14 x 17
12 x 14 12 x 15.5 14 x 14
14 x 15.5 14 x 17
HEIGHTS 5 to 10
1mm increment 4,5 to 8
1mm increment
LORDOSIS Convex NO
SPINEART SCARLET AC-T
ZIMMER OPTIO-C
KEY
FEA
TUR
ES
MATERIAL Titanium PEEK Cage + Plate
SELF LOCKING SCREWS YES NO
ANTI BACK-OUT SYSTEM INTEGRATED LOCKING CAP
SELF TAPPING AND SELF DRILLING OPTION YES SELF DRILLING
OR SELF TAPPING
ZERO PROFILE YES YES
ANATOMICAL SHAPE YES NO
IMP
LAN
T C
HA
RA
CTE
RIS
TIC
S
NUMBER OF SCREWS 2 3
FOOTPRINTS 12 x 15 14 x 17
12 x 14 14 x 16 15 x 18
HEIGHTS 5 to 10
1mm increment 6 to 12
1mm increment
LORDOSIS Convex Parallel or lordotic (6°)
SCARLET®AC-T VS ZIMMER OPTIO-C
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• Needs prior assembly of the device, in 4 complex steps • Complex connection implant / implant holder • No H05mm for collapsed disc • Only one diameter for screws (Ø3.3mm)
TAKE HOME MESSAGE
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• PREMIUM PRODUCT
• ZERO-PROFILE
• SECURED CAGE - ANTI BACK-OUT
• PRIMARY STABILITY & OSSEOINTEGRATION
• SINGLE-PIECE TI CAGE
• LARGE GRAFT WINDOW