MODIFICATION TO HIGHGATE CURVED ROD SYSTEM

K023983 · Highgate Orthopaedics · KWQ · Sep 22, 2003 · Orthopedic

Device Facts

• Record ID: K023983
• Device Name: MODIFICATION TO HIGHGATE CURVED ROD SYSTEM
• Applicant: Highgate Orthopaedics
• Product Code: KWQ · Orthopedic
• Decision Date: Sep 22, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Highgate Curved Rod System is intended for unilateral screw fixation of the anterolateral thoracolumbar spine from T6 to L5 in skeletally mature patients. The Highgate Curved Rod System is intended to provide stabilization of a spinal segment as an adjunct to spinal fusion. Indications for the use of this device include spondylolisthesis (Grades 1 and 2), spinal stenosis, pseudarthrosis, failed fusion or degenerative disc disease (DDD) defined as back pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. The Highgate Curved Rod System is not intended for patients having severe spondylolisthesis (Grades 3 and 4), deformities or curvatures, tumor or trauma i.e. vertebral fracture.

Device Story

Highgate Curved Rod System consists of titanium alloy rods and screws; used for unilateral screw fixation of anterolateral thoracolumbar spine (T6-L5). Device provides spinal segment stabilization as an adjunct to spinal fusion. Implanted by surgeons in clinical settings. Rods feature circular openings for screw attachment. System stabilizes segments in patients with degenerative conditions or failed prior fusions; excludes trauma or severe deformity cases.

Clinical Evidence

No clinical data provided; substantial equivalence established via bench testing and design comparison.

Technological Characteristics

Materials: Titanium alloy (Ti6Al4V, ASTM F136). Components: Rods and screws. Design: Rods available in two curvatures with circular openings for screw attachment. Unilateral fixation system.

Indications for Use

Indicated for skeletally mature patients requiring unilateral screw fixation of the anterolateral thoracolumbar spine (T6-L5) for stabilization as an adjunct to spinal fusion. Conditions include spondylolisthesis (Grades 1-2), spinal stenosis, pseudarthrosis, failed fusion, or degenerative disc disease. Contraindicated for severe spondylolisthesis (Grades 3-4), deformities, curvatures, tumors, or trauma (vertebral fractures).

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

• Highgate Lateral Curved Rods

Submission Summary (Full Text)

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K023983 PAGE 1/1

SEP 2 2 2003

## 510(k) SUMMARY

| Sponsor: | Highgate Orthopaedics<br>One Walnut Street<br>Boston, MA 02108 |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact<br>Person: | Kevin Connors, President |
| Proprietary Trade<br>Name: | Highgate Curved Rod System |
| Device Description: | The Highgate Curved Rod System is available in titanium<br>alloy (Ti6Al4V, ASTM F136) and includes rods and screws.<br>Screws are used to attach the rod to the thoracolumbar spine.<br>Rods are offered in two curvatures and have circular openings<br>accommodate the screws. |
| Intended Use: | The Highgate Curved Rod System is intended for unilateral<br>screw fixation of the anterolateral thoracolumbar spine from<br>T6 to L5 in skeletally mature patients. The Highgate Curved<br>Rod System is intended to provide stabilization of a spinal<br>segment as an adjunct to spinal fusion. Indications for the use<br>of this device include spondylolisthesis (Grades 1 and 2),<br>spinal stenosis, pseudarthrosis, failed fusion or degenerative<br>disc disease (DDD) defined as back pain of discogenic origin<br>with the degeneration of the disc confirmed by history and<br>radiographic studies. The Highgate Curved Rod System is not<br>intended for patients having severe spondylolisthesis (Grades<br>3 and 4), deformities or curvatures, tumor or trauma i.e.<br>vertebral fracture. |
| Materials: | The Highgate Curved Rod System components are<br>manufactured from titanium alloy (Ti6Al4V, ASTM F136). |
| Substantial<br>Equivalence: | Documentation was provided which demonstrated the<br>Highgate Medial Curved Rods to be substantially equivalent<br>to the previously cleared Highgate Lateral Curved Rods. The<br>substantial equivalence is based upon equivalence in<br>indications/intended use, manufacturing methods,<br>interconnection mechanism, basic design, materials and<br>testing. |

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Image /page/1/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the border. Inside the circle is a stylized eagle emblem with three parallel lines forming the wings and body. The eagle faces to the right.

Public Health Service

SEP 2 2 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Kevin Connors President Highgate Orthopaedics One Walnut Street Boston, Massachusetts 02108

K023983 Re:

> Trade Name: Highgate Curved Rod System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: September 5, 2003 Received: September 8, 2003

Dear Mr. Connors:

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.

If vour 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 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); 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.

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Page 2 - Mr. Kevin Connors

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,

Sincerely yours,

Mark N Milkersen

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

Enclosure

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## Indications for Use Statement

510(k) Number (if known): K023983

Device Name: Highgate Curved Rod System

Indications for Use:

The Highgate Curved Rod System is intended for unilateral screw fixation of the anterolateral thoracolumbar spine from To Lo Lo in skeletally mature patients. The Highgate Curved Rod System is intended to provide stabilization of a spinal segment as an adjunct to spinal fusion. Indications for the use of this device include spondylolisthesis (Grades 1 and 2), spinal stenosis, pseudarthrosis, failed fusion or degenerative disc disease (DDD) defined as back pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. The Highgate Curved Rod System is not intended for patients having severe spondylolisthesis (Grades 3 and 4), deformities or curvatures, tumor or trauma i.e. vertebral fracture.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-the-Counter Use

Mark N Mathews

ivision of General Restorative I Neurological Devices

) Number ***_***__ K023983

Confidential: Highgate Curved Rod System Modification