VIPER F2 FACET FIXATION SYSTEM

K101762 · Depuy Spine, Inc. · MRW · Nov 15, 2010 · OR

Device Facts

• Record ID: K101762
• Device Name: VIPER F2 FACET FIXATION SYSTEM
• Applicant: Depuy Spine, Inc.
• Product Code: MRW · OR
• Decision Date: Nov 15, 2010
• Decision: SESE
• Submission Type: Special
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The VIPER® F2 Facet Fixation System is intended to stabilize the spine as an aid to fusion by the transfacet fixation method only: Transfacet fixation: - The screws are inserted bilaterally through the superior side of the facet, across the facet joint and into the inferior pedicle. This system is indicated for the posterior surgical treatment of any or all of the following at the L1 to S1 (inclusive) spinal levels: 1) Trauma, including spinal fractures and/or dislocations; 2) Spondylolisthesis: 3) Spondylolysis; 4) Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity; 5) Degenerative diseases which include: (a) degenerative disc disease (ddd) as defined by back pain of discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radiographic studies and/or (b) degenerative disease of the facets with instability.

Device Story

VIPER® F2 Facet Fixation System consists of modified screws and washers for spinal stabilization. Device used by surgeons in posterior spinal procedures to aid fusion via transfacet fixation; screws inserted bilaterally through superior facet, across joint, into inferior pedicle. System provides mechanical stabilization to address spinal instability caused by trauma, degenerative disease, or prior surgical failure. Benefits include structural support to facilitate bone fusion. No electronic or software components.

Clinical Evidence

No clinical tests were performed. Evidence is based on bench testing, specifically static and dynamic compression and three-point bending tests conducted in accordance with ASTM F1798.

Technological Characteristics

Manufactured from ASTM F 136 implant grade titanium alloy. System comprises screws and washers of various geometries and sizes. Mechanical testing performed per ASTM F1798 for static and dynamic properties of interconnection mechanisms.

Indications for Use

Indicated for posterior surgical treatment of L1-S1 spinal levels in patients with trauma (fractures/dislocations), spondylolisthesis, spondylolysis, pseudoarthrosis, failed previous fusions, or degenerative diseases (discogenic back pain or facet instability).

Predicate Devices

• DISCOVERY Facet Screw Fixation System (K012773)
• PERPOS FCD-2 System (K090767)
• Capture Facet Screw System (K092464)
• Facet Fixation System (K061041)
• Triad Facet Screw System (K020411)
• Chameleon Fixation System (K071420)
• VIPER System (K041801)

Submission Summary (Full Text)

{0}------------------------------------------------

# K101762

## 5. 510(K) SUMMARY

.

| Submitter: | DePuy Spine, Inc.<br>325 Paramount Drive<br>Raynham, MA 02767<br>NOV 15 2010 |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Frank Jurczak<br>Sr. Regulatory Affairs Associate<br>Voice: [phone]<br>Fax: [phone]<br>E-Mail: [e-mail] |
| Date Prepared: | October 21, 2010 |
| Device Class: | Unclassified |
| Classification Name: | N/A |
| Classification Panel: | Orthopedics |
| FDA Panel Number: | 87 |
| Product Code(s): | MRW |
| Proprietary Name: | VIPER® F2 Facet Fixation System |
| Predicate Devices: | DISCOVERY Facet Screw Fixation System (K012773)<br>PERPOS FCD-2 System (K090767)<br>Capture Facet Screw System (K092464)<br>Facet Fixation System (K061041)<br>Triad Facet Screw System (K020411)<br>Chameleon Fixation System (K071420)<br>VIPER System (K041801) |
| Device Description: | The screws and washers that are the subject components of this<br>submission are modified DISCOVERY® System screws and<br>washers that are available in various geometries and sizes. |
| Intended Use: | The VIPER® F2 Facet Fixation System is intended to stabilize the<br>spine as an aid to fusion by the transfacet fixation method only: |
| | Transfacet fixation: - The screws are inserted bilaterally through<br>the superior side of the facet, across the facet joint and into the<br>inferior pedicle. |
| | This system is indicated for the posterior surgical treatment of any<br>or all of the following at the L1 to S1 (inclusive) spinal levels: 1) |

{1}------------------------------------------------

K101 762

Trauma, including spinal fractures and/or dislocations; 2) Spondylolisthesis: 3) Spondylolysis; 4) Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity; 5) Degenerative diseases which include: (a) degenerative disc disease (ddd) as defined by back pain of discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radiographic studies and/or (b) degenerative disease of the facets with instability.

Manufactured from ASTM F 136 implant grade titanium alloy. Materials:

### Comparison to

The substantial equivalence of the subject devices to the predicates Predicate Device: identified above is based upon the equivalence of intended use, design (fundamental scientific technology), materials, manufacturing methods, performance, sterility, biocompatibility, safety and packaging design.

### Nonclinical Test Summary:

The following mechanical tests were conducted:

- Static compression bending in accordance with ASTM . F1798 "Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants".
- Dynamic compression bending in accordance with ASTM . F1798 "Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants".
- Static Three-Point bending in accordance with ASTM . F1798 "Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants".
- Dynamic Three-Point bending in accordance with ASTM . F1798 "Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants".

### Clinical Test Summary:

No clinical tests were performed.

Conclusion:

Based on the predicate comparison and testing, the subject modified components of the DISCOVERY® System (marketed as the VIPER® F2 Facet Fixation System) are substantially equivalent to the predicate devices.

{2}------------------------------------------------

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MID 20993-0002

DePuy Spine, Inc. % Mr. Frank Jurczak Senior Regulatory Affairs Associate 325 Paramount Drive Raynham, Massachusetts 02767

Re: K101762

Trade/Device Name: VIPER®F2 Facet Fixation System Regulatory Class: Unclassified Product Code: MR W Dated: October 21, 2010 Received: October 22, 2010

Dear Mr. Jurczak:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading...

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21

NOV 1 5 2010

{3}------------------------------------------------

Page 2 – Mr. Frank Jurczak

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Barbara Buchm

Mark N. Melkerso Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

#### INDICATIONS FOR USE STATEMENT 1.

NOV 1 5 2010

510(k) Number (if known): K101762

Device Name: VIPER® F2 Facet Fixation System

Indications For Use:

The VIPER® F2 Facet Fixation System is intended to stabilize the spine as an aid to fusion by the transfacet fixation method only:

Transfacet fixation: - The screws are inserted bilaterally through the superior side of the facet, across the facet joint and into the inferior pedicle.

This system is indicated for the posterior surgical treatment of any or all of the following at the L1 to S1 (inclusive) spinal levels: 1) Trauma, including spinal fractures and/or dislocations; 2) Spondylolisthesis; 3) Spondylolysis; 4) Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity; 5) Degenerative diseases which include: (a) degenerative disc disease (ddd) as defined by back pain of discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radiographic studies and/or (b) degenerative disease of the facets with instability.

x Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

_
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________