SWIFT ANTERIOR CERVICAL PLATE SYSTEM

K040655 · Depuy Spine, Inc. · KWQ · Jun 2, 2004 · Orthopedic

Device Facts

• Record ID: K040655
• Device Name: SWIFT ANTERIOR CERVICAL PLATE SYSTEM
• Applicant: Depuy Spine, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: Jun 2, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Swift Anterior Cervical Plate System is intended for anterior cervical intervertebral body fixation. These systems are indicated for patients in which stability is desired following anterior cervical fusion for the indications listed below. The intended levels for treatment range from C2 to T1. Indications include symptomatic cervical spondylosis, trauma, fracture, post-traumatic kyphosis or lordosis, tumor, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), reoperation for failed fusion, or instability following surgery for the above indications.

Device Story

Swift Anterior Cervical Plate System consists of titanium alloy plates and screws used for anterior cervical intervertebral body fixation. Device provides spinal stability following fusion procedures. Used by surgeons in clinical/OR settings. System includes manual surgical instruments. Output is physical stabilization of cervical spine segments. Benefits include restoration of stability in patients with degenerative, traumatic, or neoplastic cervical conditions.

Clinical Evidence

Bench testing only.

Technological Characteristics

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

Indications for Use

Indicated for patients requiring anterior cervical intervertebral body fixation (levels C2-T1) for symptomatic cervical spondylosis, trauma, fracture, post-traumatic kyphosis/lordosis, tumor, degenerative disc disease, failed fusion reoperation, or post-surgical instability.

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

• Peak Polyaxial Anterior Cervical Plate System (K971730)
• Codman SLIM-LOC Anterior Plating System (K013877)

Submission Summary (Full Text)

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| IX. 510(k) Summary | JUN - 2 2004 K040655<br>Page 1 of 2 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SUBMITTER: | DePuy Spine, Inc.<br>325 Paramount Drive<br>Raynham, MA 02780 |
| CONTACT PERSON: | Lisa A. Gilman |
| DATE PREPARED: | March 5, 2004 |
| CLASSIFICATION NAME: | Spinal Intervertebral Body Fixation Orthosis |
| PROPRIETARY NAME: | Swift Anterior Cervical Plate System |
| PREDICATE DEVICES: | Peak Polyaxial Anterior Cervical Plate System<br>(K971730)<br><br>Codman SLIM-LOC Anterior Plating System<br>(K013877) |
| DEVICE DESCRIPTION: | The Swift Anterior Cervical Plate System consists of<br>an assortment of plates and screws.<br><br>The Swift Anterior Cervical Plate System also<br>contains Class 1 manual surgical instruments and<br>cases that are considered exempt from premarket<br>notification. |
| INTENDED USE: | The indications for use for the modified devices<br>described in this submission are the same as those<br>for the Peak Polyaxial Anterior Cervical Plate System<br>(K971730). The indications are as follows:<br><br>The Swift Anterior Cervical Plate System is intended<br>for anterior cervical intervertebral body fixation.<br>These systems are indicated for patients in which<br>stability is desired following anterior cervical fusion for<br>the indications listed below. The intended levels for<br>treatment range from C2 to T1.<br><br>Indications include symptomatic cervical spondylosis,<br>trauma, fracture, post-traumatic kyphosis or lordosis,<br>tumor, degenerative disc disease (defined as |

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discogenic pain with degeneration of the disc confirmed by history and radiographic studies), reoperation for failed fusion, or instability following surgery for the above indications.

- MATERIALS: Manufactured from ASTM F-136 implant grade titanium alloy.

| PERFORMANCE | |
|-------------|----------------------------------------------------------------------------------------------|
| DATA: | Performance data were submitted to characterize the<br>Swift Anterior Cervical Plate System. |

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract image of a bird-like figure, which is the department's symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

UN - 2 2004

Ms. Sharon Starowicz Director, Regulatory Affairs DePuy Spine, Inc. 325 Paramount Drive Raynham, MA 02767-0350

Re: K040655

Trade/Device Name: Swift Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: March 8, 2004 Received: March 12, 2004

Dear Ms. Starowicz:

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.

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 – Ms. Sharon Starowicz

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" (21 CFR 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,

Miriam C. Provost

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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## 111. Indications for Use

Page 1 of 1

510(k) Number (if known): __ Koyo G55

Swift Anterior Cervical Plate System Device Name:

Indications For Use:

The Swift Anterior Cervical Plate System is intended for anterior cervical intervertebral body fixation. These systems are indicated for patients in which stability is desired following anterior cervical fusion for the indications listed below. The intended levels for treatment range from C2 to T1.

Indications include symptomatic cervical spondylosis, trauma, fracture, posttraumatic kyphosis or lordosis, tumor, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), re-operation for failed fusion, or instability following surgery for the above indications.

(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) | <span style="text-decoration: overline;">X</span> |
|----------------------------------------|---------------------------------------------------|
| OR Over-The-Counter Use: | ____________________ |

Miriam C. Provost

(Division Sign-Off)

Division of General, Restorative,

and Neurological Devices