VIPER 2 SYSTEM

K090648 · Depuy Spine, Inc. · NKB · Jun 10, 2009 · Orthopedic

Device Facts

• Record ID: K090648
• Device Name: VIPER 2 SYSTEM
• Applicant: Depuy Spine, Inc.
• Product Code: NKB · Orthopedic
• Decision Date: Jun 10, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The VIPER Systems are intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The VIPER Systems are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudarthrosis; and failed previous fusion in skeletally mature patients. When used in a percutaneous approach with MIS Instrumentation, the VIPER Systems are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients. The PEEK rods of EXPEDIUM Spine System and VIPER Systems are contraindicated for degenerative disc disease.

Device Story

VIPER 2 System consists of 5.5mm spinal screws and rods used for immobilization and stabilization of thoracic, lumbar, and sacral spinal segments. Device components are implanted by surgeons during spinal fusion procedures, including percutaneous approaches using MIS instrumentation. System provides mechanical support to stabilize spinal segments, facilitating fusion in patients with instabilities or deformities. Output is physical stabilization of the spine. Benefits include correction of spinal alignment and stabilization of unstable segments. No software or algorithmic components involved.

Clinical Evidence

Bench testing only. Performance data per ASTM F 1717 submitted to characterize subject components.

Technological Characteristics

Materials: ASTM F 138 stainless steel, ASTM F 136 titanium alloy, and ASTM F 1537 cobalt-chromium-molybdenum alloy. Components include 5.5mm screws and rods in various geometries/sizes. Mechanical stabilization principle. No software or electronic components.

Indications for Use

Indicated for skeletally mature patients requiring spinal immobilization/stabilization as an adjunct to fusion for thoracic, lumbar, and sacral spine instabilities or deformities. Specific indications: degenerative disc disease, spondylolisthesis, trauma (fracture/dislocation), spinal stenosis, scoliosis, kyphosis, lordosis, tumor, pseudarthrosis, and failed previous fusion. Contraindicated for PEEK rods in degenerative disc disease.

Regulatory Classification

Identification

(1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.

Special Controls

*Classification.* (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards; (ii) Compliance with mechanical testing standards; (iii) Compliance with biocompatibility standards; and (iv) Labeling that contains these two statements in addition to other appropriate labeling information: “Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.” “Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.” (2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls: (i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use. (ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant. (iii) Device components must be demonstrated to be biocompatible. (iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments. (v) Labeling must include the following: (A) A clear description of the technological features of the device including identification of device materials and the principles of device operation; (B) Intended use and indications for use, including levels of fixation; (C) Identification of magnetic resonance (MR) compatibility status; (D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and (E) Detailed instructions of each surgical step, including device removal. (3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls: (i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate. (ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.

Predicate Devices

• EXPEDIUM Spine System (K082942, K033901, K041119, K073364)
• VIPER System (K071860, K061520, K041801)
• MOSS MIAMI Spine System (K933881, K962628, K983583)

Submission Summary (Full Text)

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K090648

Special 510(k) Submission – Additions to VIPER™ System

| 5. | <b>510(K) SUMMARY</b> |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | DePuy Spine, Inc.<br>325 Paramount Drive<br>Raynham, MA 02767 |
| | JUN 10 2009 |
| Contact Person: | Frank Jurczak<br>Regulatory Affairs Associate |
| Voice: | [phone] |
| Fax: | [phone] |
| E-Mail: | [e-mail] |
| Date Prepared: | March 9, 2009 |
| Device Class: | Class III |
| Classification Name: | Spinal interlaminar fixation orthosis<br>per 21 CFR §888.3050<br><br>Spinal intervertebral body fixation orthosis<br>per 21 CFR §888.3060<br><br>Pedicle screw spinal fixation<br>per 21 CFR §888.3070 |
| Classification Panel: | Orthopedics |
| FDA Panel Number: | 87 |
| Product Code(s): | NKB, KWQ, KWP, MNH, MNI |
| Proprietary Name: | VIPER ^TM 2 System |
| Predicate Devices: | EXPEDIUM ^TM Spine System (K082942, K033901,<br>K041119, K073364)<br>VIPER System (K071860, K061520, K041801)<br>MOSS MIAMI Spine System (K933881, K962628,<br>K983583) |
| Device Description: | The subject VIPER2 Spine System components consist of<br>5.5mm screws and rods and are available in various<br>geometries and sizes. |
| Intended Use: | The VIPER Systems are intended to provide<br>immobilization and stabilization of spinal segments in<br>skeletally mature patients as an adjunct to fusion in the |

DePuy Spine, Inc., a Johnson & Johnson Company

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KGA D648

Special 510(k) Submission - Additions to VIPERTM System

treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.

The VIPER Systems are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudarthrosis; and failed previous fusion in skeletally mature patients.

When used in a percutaneous approach with MIS Instrumentation, the VIPER Systems are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

The PEEK rods of EXPEDIUM Spine System and VIPER Systems are contraindicated for degenerative disc disease.

Materials:

Manufactured from ASTM F 138 implant grade stainless steel, ASTM F 136 implant grade titanium alloy, and ASTM F 1537 implant grade cobalt-chromiummolybdenum alloy.

Performance Data: Performance data per ASTM F 1717 were submitted to characterize the subject VIPER2 System components addressed in this notification.

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DePuy Spine, Inc., a Johnson & Johnson Company

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services, USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" around the perimeter. In the center of the seal is an emblem of an eagle.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K090648

Trade/Device Name: VIPER™ 2 System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle Screw Spinal System Regulatory Class: III Product Code: NKB, KWQ, KWP, MNH, & MNI Dated: May 12, 2009 Received: May 13, 2009

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.

JUN 1 0 2009

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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing

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Page 2-Mr. Frank Jurczak

(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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours.

Barbara buerho

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

Enclosure

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## INDICATIONS FOR USE STATEMENT 4.

510(k) Number (if known): K090648

Device Name: VIPER™2 System

## Indications For Use:

The VIPER Systems are intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.

The VIPER Systems are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudarthrosis; and failed previous fusion in skeletally mature patients.

When used in a percutaneous approach with MIS Instrumentation, the VIPER Systems are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

The PEEK rods of EXPEDIUM Spine System and VIPER Systems are contraindicated for degenerative disc disease.

Prescription Use X (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)

# #

for vision Sign-Off)

Unvision of Surgical, Orthopedic, and Restorative Devices

19(k) Number K090648

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DePuy Spine, Inc., a Johnson & Johnson Company