HYBRID ANTERIOR CERVICAL PLATE SYSTEM

K052552 · Depuy Spine, Inc. · KWQ · Oct 13, 2005 · Orthopedic

Device Facts

• Record ID: K052552
• Device Name: HYBRID ANTERIOR CERVICAL PLATE SYSTEM
• Applicant: Depuy Spine, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: Oct 13, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Hybrid Anterior Cervical Plate System is indicated for stabilization of the cervical spine from C2 to C7 employing unicortical screw fixation at the anterior face of the vertebral bodies. Specific clinical indications for anterior plating include: instability caused by trauma; instability associated with correction of cervical lordosis and kyphosis deformity; instability associated with pseudoarthosis as a result of previously failed cervical spine surgery; instability associated with major reconstructive surgery for primary tumors or metastatic malignant tumors of the cervical spine; instability associated with single or multiple level corpectomy in advanced degenerative disc disease, spinal canal stenosis and cervical myleopathy.

Device Story

Hybrid Anterior Cervical Plate System consists of titanium alloy plates and screws; used for anterior cervical spine stabilization. Implanted by surgeons during spinal reconstructive procedures to address instability from trauma, tumors, or degenerative disease. Provides mechanical fixation to vertebral bodies; supports fusion process. System includes manual surgical instruments for implantation.

Clinical Evidence

Bench testing only. Performance data submitted to characterize device components.

Technological Characteristics

Manufactured from ASTM F-136 implant grade titanium alloy. System comprises plates and screws for spinal intervertebral body fixation. Manual surgical instruments included.

Indications for Use

Indicated for patients requiring cervical spine stabilization (C2-C7) due to trauma, deformity (lordosis/kyphosis), pseudoarthrosis from failed surgery, tumors (primary/metastatic), or degenerative conditions (corpectomy, stenosis, myelopathy).

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

• SLIM-LOC™ Anterior Cervical Plate System (K013877)

Submission Summary (Full Text)

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

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the upper portion of the circle. The logo is black and white.

OCT 2 5 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Sharon Starowicz Director, Regulatory Affairs Depuy Spine, A Johnson & Johnson Company 325 Paramount Drive Raynham, MA 02767-0350

Re: K052552

Trade Name: Hybrid Anterior Cervical Plate Systme Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation System Regulatory Class: II Product Code: KWQ Dated: September 15, 2005 Received: September 16, 2005

Dear Ms. Starowicz:

This letter corrects our substantially equivalent letter of October 13, 2005.

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 (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 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.

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

Page 2 - Ms. Sharon Starowicz

This letter will allow you to continue 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,

Signature

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

## Indications for Use

510(k) Number: K052552

Device Name: Hybrid Anterior Cervical Plate System

Indications For Use:

The Hybrid Anterior Cervical Plate System is indicated for stabilization of the cervical spine from C2 to C7 employing unicortical screw fixation at the anterior face of the vertebral bodies. Specific clinical indications for anterior plating include: instability caused by trauma; instability associated with correction of cervical lordosis and kyphosis deformity; instability associated with pseudoarthosis as a result of previously failed cervical spine surgery; instability associated with major reconstructive surgery for primary tumors or metastatic malignant tumors of the cervical spine; instability associated with single or multiple level corpectomy in advanced degenerative disc disease, spinal canal stenosis and cervical myleopathy

Prescription Use X = AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Us (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)

_

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number_Kos 255-

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

## 510(k) Summary

.

| SUBMITTER: | DePuy Spine, Inc.<br>325 Paramount Drive<br>Raynham, MA 02780 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Liz Lavelle |
| DATE PREPARED: | September 15, 2005 |
| CLASSIFICATION NAME: | Spinal Intervertebral Body Fixation Orthosis<br>§888.3060 |
| PROPRIETARY NAME: | Hybrid Anterior Cervical Plate System |
| PREDICATE DEVICE: | SLIM-LOC™ Anterior Cervical Plate System, K013877 |
| DEVICE DESCRIPTION: | The Hybrid Anterior Cervical Plate System consists of an<br>assortment of plate and screws. |
| | The Hybrid Anterior Cervical Plate System also contains<br>Class 1 manual surgical instruments and cases that are<br>considered exempt from premarket notification. |
| INTENDED USE: | The Hybrid Anterior Cervical Plate System is indicated for<br>stabilization of the cervical spine from C2 to C7 employing<br>unicortical screw fixation at the anterior face of the vertebral<br>bodies. Specific clinical indications for anterior plating<br>include: instability caused by trauma; instability associated<br>with correction of cervical lordosis and kyphosis deformity;<br>instability associated with pseudoarthosis as a result of<br>previously failed cervical spine surgery; instability<br>associated with major reconstructive surgery for primary<br>tumors or metastatic malignant tumors of the cervical spine;<br>instability associated with single or multiple level<br>corpectomy in advanced degenerative disc disease, spinal<br>canal stenosis and cervical myleopathy. |
| MATERIALS: | Manufactured from ASTM F-136 implant grade titanium<br>alloy. |
| PERFORMANCE<br>DATA: | Performance data were submitted to characterize the<br>Hybrid Anterior Cervical Plate System components. |