HIGHGATE CURVED ROD SYSTEM

K012045 · Highgate Orthopaedics · KWQ · Mar 12, 2002 · Orthopedic

Device Facts

• Record ID: K012045
• Device Name: HIGHGATE CURVED ROD SYSTEM
• Applicant: Highgate Orthopaedics
• Product Code: KWQ · Orthopedic
• Decision Date: Mar 12, 2002
• Decision: SESE
• Submission Type: Traditional
• 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 T10 to L5. 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; designed for unilateral screw fixation of anterolateral thoracolumbar spine (T10-L5). Device provides spinal segment stabilization as an adjunct to spinal fusion. Used by surgeons in clinical settings. Components include rods with two curvatures and circular openings for screw attachment. System stabilizes spinal segments to facilitate fusion in patients with degenerative conditions or failed prior fusions. Benefit is improved spinal stability.

Clinical Evidence

Bench testing only. Static and fatigue mechanical testing were performed to demonstrate safety and effectiveness.

Technological Characteristics

Materials: Titanium alloy (Ti6Al4V, ASTM F136). Components: Rods and screws. Configuration: Anterolateral unilateral screw fixation system. Energy source: None (mechanical). Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for patients requiring stabilization of the thoracolumbar spine (T10-L5) as an adjunct to spinal fusion. Conditions include spondylolisthesis (Grades 1-2), spinal stenosis, pseudarthrosis, failed fusion, or degenerative disc disease. Contraindicated for patients with severe spondylolisthesis (Grades 3-4), spinal deformities/curvatures, tumors, or trauma (e.g., 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.

Submission Summary (Full Text)

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# MAR 1 2 2002

Sponsor:

Proposed Proprietary Trade Name: Device Description:

Indication/Intended Use:

Materials:

Substantial Equivalence:

Performance Characteristics:

# 510(k) SUMMARY of Safety and Effectiveness

K012045
page 1 of 1

Highgate Orthopaedics One Walnut Street Boston, MA 02108

Highgate Curved Rod System

The Highgate Curved Rod System is available in titanium alloy (Ti6A14V, ASTM F136) and includes rods and screws. Lateral and end screws are used to attach the rod to the thoracolumbar spine. Rods are offered in two curvatures and have circular openings accommodate the screws.

The Highgate Curved Rod System is intended for fixation of the anterolateral unilateral screw thoracolumbar spine from To to L5. 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.

The Highgate Curved Rod System components are manufactured from titanium alloy (Ti6A14V, ASTM F136).

The Highgate Curved Rod System was determined to be substantially equivalent to several commercially available systems.

Static and fatigue mechanical testing were supplied in support of the Highgate Curved Rod System 510(k) premarket notification.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 2 2002

Highgate Orthopaedics c/o Ms. Karen E. Warden, MEBE Representative/Consultant 8202 Sherman Road Chesterland, Ohio 44026-2141

Re:

Highgate Curved Rod System Regulation Number: 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: II Product Code: KWQ Dated: February 13, 2002 Received: February 20, 2002

Dear Ms. Warden:

K012045

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regars) and entirent date of the Medical Device Amendments, or to conmerce proc to Hiley 20, 2017, in accordance with the provisions of the Federal Food, Drug, de MCS that have been rocuse in avere approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 1 ou may, dicierore, market the Act include requirements for annual registration, listing of The general vontable proving 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 II your device is classified (500 above) and Existing major regulations affecting your device can may be subject to such additions, 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 I loase be advisou that I Dr o resuarted on our device complies with other requirements of the Act that I Dri has made a sond regulations administered by other Federal agencies. You must of any I cachi statutes and regulanents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR Part 6077, laboring (21 CFR Part 820); and if applicable, the electronic 10.11 m the quality bysellis (Sections 531-542 of the Act); 21 CFR 1000-1050.

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## Page 2 - Ms. Karen E. Warden, MEBE

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow you'le begin maing of substantial equivalence of your device to a legally promatics notication: "The PDF Intentigstification 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 and 11 you desire specific ad 1809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 OF Far 859. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Outer general 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,

Mule N Mule

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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## 4. Indications for Use Statement

510(k) Number (if known): k012045

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 to L5. 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.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Over-the-Counter Und 0(k) Number

L. Mark Miller

Sign-Off vision of General. Restorative and Neurological Devices

Prescription Use (Per 21 CFR 801.109)

Confidential: Highgate Curved Rod Premarket Notification

OR

012045