INDICATIONS & CONTRAINDICATIONS...11 COMPACTOR TRY-IN 01 00-N 12 EXTRACTOR SCA-IC 08 00-N 13...

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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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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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 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 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 00-N


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 00-N


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 00-N


HAN-SI AO 08-N


SCA-IC 06 00-N


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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HAN-SI AO 08-N


SCA-IC 06 00-N


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


SYNTHES ZERO PVA

KEY

FEA

TUR

ES

MATERIAL Titanium PEEK + Titanium


ANTI BACK-OUT SYSTEM INTEGRATED STOP BUTTON


YES SELF DRILLING

OR SELF TAPPING

ZERO PROFILE YES NO

ANATOMICAL SHAPE YES YES

IMP

LAN

T C

HA

RA

CTE

RIS

TIC

S



15 x 13.6 17.5 x 16.6

HEIGHTS 5 to 10


1mm increment

LORDOSIS Convex Parallel, Convex, Lordotic


SYNTHES ZERO P

KEY

FEA

TUR

ES


SELF LOCKING SCREWS YES YES

ANTI BACK-OUT SYSTEM INTEGRATED INTEGRATED


YES NO

Self drilling only

ZERO PROFILE YES YES


IMP

LAN

T C

HA

RA

CTE

RIS

TIC

S



13.5x17.5 16.5 x 17.5

HEIGHTS 5 to 10


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


Styker AVS Anchor

KEY

FEA

TUR

ES





YES YES



Parallel

IMP

LAN

T C

HA

RA

CTE

RIS

TIC

S



12 x 14 14 x 16

HEIGHTS 5 to 10


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


K2M Chesapeake

KEY

FEA

TUR

ES

MATERIAL Titanium Titanium




YES NO

Only self tapping



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


Globus Coalition

KEY

FEA

TUR

ES



ANTI BACK-OUT SYSTEM INTEGRATED PIVOTING STOP


YES NO

ZERO PROFILE YES NO


IMP

LAN

T C

HA

RA

CTE

RIS

TIC

S



12x14 14x16 15x18

HEIGHTS 5 to 10


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


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 »



IMP

LAN

T C

HA

RA

CTE

RIS

TIC

S NUMBER OF SCREWS 2 0


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


ZIMMER OPTIO-C

KEY

FEA

TUR

ES

MATERIAL Titanium PEEK Cage + Plate


ANTI BACK-OUT SYSTEM INTEGRATED LOCKING CAP

SELF TAPPING AND SELF DRILLING OPTION YES SELF DRILLING

OR SELF TAPPING



IMP

LAN

T C

HA

RA

CTE

RIS

TIC

S



12 x 14 14 x 16 15 x 18

HEIGHTS 5 to 10


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

INDICATIONS & CONTRAINDICATIONS...11 COMPACTOR TRY-IN 01 00-N 12 EXTRACTOR SCA-IC 08 00-N 13...

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Transcript of INDICATIONS & CONTRAINDICATIONS...11 COMPACTOR TRY-IN 01 00-N 12 EXTRACTOR SCA-IC 08 00-N 13...