KOBRA GPS FIXATION SYSTEM

K042859 · Medtronic Vertelink, Inc. · KWQ · Nov 24, 2004 · Orthopedic

Device Facts

• Record ID: K042859
• Device Name: KOBRA GPS FIXATION SYSTEM
• Applicant: Medtronic Vertelink, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: Nov 24, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the KOBRA™GPS Fixation System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis). In addition, when used as a pedicle screw fixation system, the KOBRA™GPS Fixation System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass.

Device Story

The KOBRA™ GPS Fixation System is a spinal stabilization device consisting of cannulated rods and cannulated multi-axial screws. It is used by surgeons in the operating room to provide immobilization and stabilization of thoracic, lumbar, and sacral spinal segments as an adjunct to fusion. Components are implanted and locked into configurations tailored to the individual patient's anatomy. The system facilitates spinal fusion by maintaining alignment during the healing process. No software or electronic components are involved.

Clinical Evidence

No clinical data provided; substantial equivalence is supported by bench testing.

Technological Characteristics

System consists of cannulated rods and cannulated multi-axial screws for spinal fixation. Materials and design are consistent with previously cleared spinal fixation systems. Mechanical device; no energy source, software, or connectivity.

Indications for Use

Indicated for skeletally mature patients requiring non-cervical posterior spinal fixation for degenerative spondylolisthesis with neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, or pseudarthrosis. Also indicated for severe L5-S1 spondylolisthesis (Grades 3-4) using autogenous bone graft, with fixation at L3 or below.

Regulatory Classification

Identification

A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.

Predicate Devices

• Vertelink KOBRA™ Fixation System (K032102)
• CD HORIZON® Spinal System (K000453)

Submission Summary (Full Text)

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

NOV 2 4 2004

K042859

## Medtronic Vertelink KOBRA™ GPS Fixation System Summary of Safety and Effectiveness October 2004

I. Company: Medtronic Vertelink, Inc 30 Hughes, Suite 206 Irvine, CA, 92618 [phone]

> Contact: Samuel M. Shaolian Vice President, Product Development

- II. Proposed Proprietary Trade Name: Vertelink KOBRA™ Fixation System
- III. Classification Name: Spinal Intervertebral Fixation Orthosis and/or Pedicle Screw Spinal System (per 21 CFR Section 888.3060 and/or 888.3070) Class: Class II Product Code: MNH, MNI, KWO

#### IV. Product Description

The Medtronic Vertelink KOBRA™ GPS Fixation System consists of a variety of cannulated rods and cannulated multi-axial screws used to build a spinal construct. Instrumentation is also available to facilitate implantation of the device components.

The KOBRA™ GPS Fixation System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. The KOBRA™ GPS implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.

#### V. Indications

When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the KOBRA™GPS Fixation System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the KOBRA™GPS Fixation System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass.

#### VI. Substantial Equivalence

Documentation, including test reports, was provided which demonstrated the Vertelink KOBRA™ GPS Fixation System to be substantially equivalent to the Vertelink KOBRA™ Fixation System components previously cleared in K032102 and to the CD HORIZON® Spinal System (K000453).

Page 1 of 1

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

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized caduceus, a symbol often associated with healthcare and medicine. The caduceus consists of a staff with two snakes coiled around it, topped with wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 4 2004

Mr. Samuel M. Shaolian Vice President, Product Development Medtronic Vertelink, Inc. 30 Hughes, Suite 206 Irvine, California 92618

Re: K042859

Ro42039
Trade/Device Name: Vertelink KOBRATM GPS Fixation System Regulation Number: 21 CFR 888.3060, 888.3070 Regulation Name: Spinal intervertebral body fixation orthosis, Pedicle screw spinal system Regulatory Class: II Product Code: KWQ, MNI, MNH Dated: October 14, 2004 Received: October 15, 2004

Dear Mr. Shaolian:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can he 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); good manufacturing practice requirements as sct 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.

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

Page 2 - Mr. Samuel M. Shaolian

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/dsma/dsmamain.html

Sincerely yours,

fo Mark A. Millman

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

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

# Indications for Use

### 510(k) Number (if known):_K042859

Device Name:_______________________________________________________________________________________________________

Indications For Use:

When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the KOBRA™GPS Fixation System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the KOBRA™GPS Fixation System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass.

× 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)

Mark A. Millers
(Division Sign Off)

ral. Restorative. and Neurological Devices

Page 1 of __ 1 September 2004

**510(k) Number** K042854