OLSEN MEDICAL ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM

K042073 · Olsen Medical · KWQ · Feb 7, 2005 · Orthopedic

Device Facts

• Record ID: K042073
• Device Name: OLSEN MEDICAL ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM
• Applicant: Olsen Medical
• Product Code: KWQ · Orthopedic
• Decision Date: Feb 7, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Olsen Medical Dynamic and Semiconstrained Plates are intended for anterior screw fixation of the cervical spine (C2 to C7) for the following indications: degenerative disc disease (neck pain of discogenic origin with degeneration of the disc, confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis and tumors (primary and metastatic), deformities or curvatures (i.e., scoliosis, kyphosis, and lordosis), pseudoarthrosis and failed previous fusions.

Device Story

Anterior cervical vertebrae plate system consisting of titanium alloy plates and locking screws; used for spinal fixation in cervical spine (C2-C7). Plates available in dynamic (slotted) and semiconstrained (round hole) configurations; lengths 23mm-109mm; curved in longitudinal and lateral planes. Implanted by surgeons during spinal procedures to stabilize vertebrae. Provides mechanical support to facilitate fusion and treat conditions like degenerative disc disease, trauma, and deformities. Output is physical stabilization of the cervical spine.

Clinical Evidence

Bench testing only. Mechanical testing performed per ASTM 1717 in accordance with FDA Guidance for Spinal System 510(k)s (May 3, 2004) to demonstrate substantial equivalence.

Technological Characteristics

Materials: Medical grade titanium alloy Ti6 Al4 V (ASTM F136 or ASTM 1472). Design: Dynamic (slotted) and semiconstrained (round hole) plates; 23mm-109mm lengths; 16mm/19mm widths; longitudinal and lateral curvature. Energy source: None (mechanical). Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for anterior screw fixation of the cervical spine (C2-C7) in patients with degenerative disc disease, spondylolisthesis, trauma (fracture/dislocation), spinal stenosis, tumors, spinal deformities (scoliosis, kyphosis, lordosis), pseudoarthrosis, or failed previous fusions.

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

• Synthes CSKP Variable Angle Cervical Plate Locking System (K031276)

Submission Summary (Full Text)

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## 510(k) Summary

## SUBMITTED BY

Doug Mc Whorter Olsen Medical 3001 W Kentucky Street Louisville, KY 40211

Date Submitted: July 20, 2004

# CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME

Trade/Proprietary Name: Common/Usual Name: Device Product Code: Classification:

Olsen Medical Anterior Cervical Vertebrae Plate System Cervical Plating Instrumentation KWO 888.3060 Spinal Intervertebral Body Fixation Orthosis

### PREDICATE DEVICE

Classification Name:

Synthes CSKP Variable Angle Cervical Plate Locking System (K031276)

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92

# DEVICE DESCRIPTION AND MATERIALS OF CONSTRUCTION

The Olsen Medical Anterior Cervical Vertebrae Plate System consists of plates and locking screws. The plate attaches to the anterior portion of the vertebral body of the cervical spine (levels C2 to C7).

The Olsen Medical Dynamic and Semiconstrained Plate Systems each come in lengths ranging from 23mm to 109mm. All of the plates, regardless of the length, are 16mm and 19mm wide at the cephalad and caudal ends of the plate, respectively. The Dynamic Plates have slots to receive the screws and the Semiconstrained Plates have round holes to receive the screws. All other plate dimensions are the same. Both plates each have tack holes and drill guide holes at the cephalad and caudal ends of the plate. Both plates are curved both in the longitudinal and lateral planes.

The implants of these systems are manufactured from medical grade titanium alloy Ti6 Al4 V meeting the requirements of ASTM F136 or ASTM 1472.

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## INDICATIONS FOR USE

The Olsen Medical Dynamic and Semiconstrained Plates are intended for anterior screw fixation of the cervical spine (C2 to C7) for the following indications: degenerative disc disease (neck pain of discogenic origin with degeneration of the disc, confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis and tumors (primary and metastatic), deformities or curvatures (i.e., scoliosis, kyphosis, and lordosis), pseudoarthrosis and failed previous fusions.

## PERFORMANCE DATA

Testing for substantial equivalence to the Synthes CSPL Variable Angle device is done per ASTM 1717 in accordance with FDA Guidance for Spinal System 510(k)s, May 3, 2004.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 7 2005

Mr. Larry D. Potts Olsen Medical 3001 West Kentucky Street Louisville, Kentucky 40211

Re: K042073

> Trade/Device Name: Anterior Cervical Vertebrae Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: January 13, 2004 Received: January 13, 2004

Dear Mr. Potts:

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 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 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.

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#### Page 2 - Mr. Larry D. Potts

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. 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/industry/support/index.html.

Sincerely yours.

Mark H. Milken

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:

510(k) Number (if known): K042073

Device Name:

Indications For Use:

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Olsen Medical Anterior Cervical Vertebrae Plate System The Olsen Medical Dynamic and Semiconstrained Plates are

intended for anterior screw fixation of the cervical spine (C2 to C7) for the following indications: degenerative disc disease (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis and tumors (primary and metastatic), deformities or curvatures (i.e., scoliosis, kyphosis, and lordosis), pseudoarthrosis and failed previous fusions.

Prescription Use V (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 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. Melkeson

and New

K042073
510(k) Number