MICHELSON ANTERIOR CERVICAL PLATE SYSTEM

K974435 · Wrightmedicaltechnologyinc · KWQ · Feb 19, 1998 · Orthopedic

Device Facts

• Record ID: K974435
• Device Name: MICHELSON ANTERIOR CERVICAL PLATE SYSTEM
• Applicant: Wrightmedicaltechnologyinc
• Product Code: KWQ · Orthopedic
• Decision Date: Feb 19, 1998
• Decision: SN
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Michelson Anterior Cervical Plate System is intended to provide stability while allowing the cervical spine to fuse for the following indications: - Instability caused by trauma (including fractures); - Instability associated with correction of cervical lordosis, scoliosis and kyphosis deformity; - Instability associated with tumors; - Instability associated with degenerative disk diseases defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies; - Instability from failed previous fusions. Warning: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

Device Story

Michelson Anterior Cervical Plate System provides anterior cervical spine stabilization to facilitate fusion. Components include cervical plate, preassembled locking cap, and bone screws. Used by surgeons in clinical settings to address instability from trauma, deformity, tumors, degenerative disc disease, or failed fusions. Device provides mechanical support to the spine; does not involve software or algorithms. Benefit is improved spinal stability during the fusion process. Not approved for posterior pedicle fixation.

Clinical Evidence

Bench testing only. Fatigue strength testing was performed to compare the device to predicate systems; results indicated comparable strength and adequacy for the intended use.

Technological Characteristics

Constructed from titanium alloy (Ti-6Al-4V). System consists of a cervical plate, preassembled locking cap, and bone screws. Mechanical fixation device; no energy source, software, or connectivity.

Indications for Use

Indicated for patients requiring cervical spine stabilization to facilitate fusion due to trauma (fractures), deformity correction (lordosis, scoliosis, kyphosis), tumors, degenerative disc disease (discogenic pain confirmed by history/radiography), or failed previous fusions. Contraindicated for posterior element (pedicle) fixation in cervical, thoracic, or lumbar spine.

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

• ORION Anterior Cervical Plate
• Synthes CSLP System

Submission Summary (Full Text)

{0}

FEB 19 1998
K974435

# 510(k) Summary

Contact Person: Dan Regan
Date Prepared: February 4, 1998

Trade/Proprietary Name: Michelson Anterior Cervical Plate System
Common Name: Anterior Cervical Plate System
Predicate Device: ORION Anterior Cervical Plate, Synthes CSLP System

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

## Description/Intended Use

The Michelson Anterior Cervical Plate System consists of a cervical plate, locking cap and bone screw. The locking cap is preassembled onto the plate.

The Michelson Anterior Cervical Plate System is intended to provide stability while allowing the cervical spine to fuse for the following indications:

- Instability caused by trauma (including fractures);
- Instability associated with correction of cervical lordosis, scoliosis and kyphosis deformity;
- Instability associated with tumors;
- Instability associated with degenerative disk diseases defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies;
- Instability from failed previous fusions.

**Warning:** This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

## Materials

All the components are made from titanium alloys (Ti-6Al-4V).

## Testing Summary

Submitted testing demonstrates that the Michelson Anterior Cervical Plate System fatigue strength is comparable to a predicate device and adequate for its intended use.

{1}

DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850
FEB 19 1998

Mr. Dan Regan
Manager, Regulatory Affairs
Wright Medical Technology, Inc.
5677 Airline Road
Arlington, Tennessee 38002

Re: K974435
Michelson Anterior Cervical Plate
Regulatory Class: II
Product Code: KWQ
Dated: November 21, 1997
Received: November 24, 1997

Dear Mr. Regan:

We have reviewed your Section 510(k) notification of intent to market the device system referenced above and we have determined the device system is substantially equivalent (for the indications for use stated in the enclosure) to device systems marketed in interstate commerce prior to May 28, 1976 or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market your device system subject to the general controls provisions of the Act and the limitations identified below.

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. Note that labeling or otherwise promoting this device system for pedicular screw fixation/attachment would cause the device system to be adulterated under 501(f)(1) of the Act.

FDA identifies that any device system, if intended for use in pedicular screw fixation/attachment, except for some limited indications, would be found not substantially equivalent and would be a class III device under Section 513(f) of the Act. Class III devices are required to have an approved premarket approval (PMA) application prior to marketing. Accordingly:

1. You may not label or in any way promote this device system for pedicular screw attachment to, or fixation of the cervical, thoracic or lumbar vertebral column. Therefore, in order to prevent off-label promotion, the package insert must include the following statement, "WARNING: This device system is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.";

{2}

Page 2 - Mr. Dan Regan

2. All labeling for this device system, including the package label, must state that there are labeling limitations. The package insert must prominently state that the device system is intended for the specific use(s) described in the enclosure only; and

3. Pedicular screw fixation/attachment to the cervical, thoracic or lumbar vertebral column, except for limited indications, of any device system is considered investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) regulations under 21 CFR, Part 812. All users of the device system for pedicular screw fixation/attachment must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) prior to conducting an investigation.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.

FDA advises that the use of the subject device system and/or device components with any other device components but those identified in this 510(k) would require submission of a new 510(k) providing documentation of design, material, and labeling compatibility between the device components. Mechanical testing of a spinal system consisting of the subject device components and other device components, whether yours or other manufacturers', may also be required.

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

{3}

Page 3 - Mr. Dan Regan

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for *in vitro* diagnostic devices), please contact the Office of Compliance at [phone]. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,


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

Enclosure

{4}

Wright Medical Technology, Inc.
Attachment 2
Premarket Notification
Michelson Anterior Cervical Plate System

# C. Indications for Use of the Device

510(k) Number (if known): K974435

Device Name: Michelson Anterior Cervical Plate System

## Indications for Use:

The Michelson Anterior Cervical Plate System is intended to provide stability while allowing the cervical spine to fuse for the following indications:

- Instability caused by trauma (including fractures);
- Instability associated with correction of cervical lordosis, scoliosis and kyphosis deformity;
- Instability associated with tumors;
- Instability associated with degenerative disk diseases defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies;
- Instability from failed previous fusions.

**Warning:** This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

(Please do not write below this line—continue on another page if needed)

* * * * * * * * * *

Concurrence of CDRH, Office of Device Evaluation (ODE)


Prescription Use ☑ Or Over-the-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-7)