ANTERIOR CERVICAL PLATE SYSTEM

K013439 · Scien'Tx USA, Inc. · KWQ · Jan 14, 2002 · Orthopedic

Device Facts

• Record ID: K013439
• Device Name: ANTERIOR CERVICAL PLATE SYSTEM
• Applicant: Scien'Tx USA, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: Jan 14, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of a solid spinal fusion in patients with neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies (DDD), trauma (i.e. fractures), tumors, deformities (i.e. kyphosis, lordosis, and scoliosis), pseudoarthrosis, spinal stenosis, and failed previous fusions. WARNING: These devices are not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

Device Story

Anterior Cervical Plate System provides temporary stabilization of the anterior cervical spine to facilitate solid spinal fusion. System consists of titanium alloy plates and screws. Used by surgeons in clinical settings to treat conditions including DDD, trauma, tumors, deformities, pseudoarthrosis, spinal stenosis, and failed fusions. Device is implanted to provide mechanical support during the fusion process. Not for posterior pedicle fixation.

Clinical Evidence

Bench testing only. Static and fatigue compression and static torsion testing performed per ASTM F1717-96.

Technological Characteristics

Titanium alloy (Ti-6A1-4V) conforming to ASTM F136. Mechanical fixation system consisting of plates and screws. Testing performed per ASTM F1717-96.

Indications for Use

Indicated for patients requiring temporary stabilization of the anterior cervical spine during solid spinal fusion. Applicable for discogenic neck pain (DDD), trauma (fractures), tumors, deformities (kyphosis, lordosis, scoliosis), pseudoarthrosis, spinal stenosis, and failed previous fusions. Contraindicated for posterior element (pedicle) fixation.

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

• Sofamor Danek – Orion System (K973854)
• DePuy - DePuy Motech PEAK (K971730)

Submission Summary (Full Text)

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K013439

page 1 of 1

### 510(k) Summary of Safety and Effectiveness

| Submitter's name: | Scient'x |
|------------------------------------|-----------------------------------------------------------|
| Submitter's address: | Guyancourt, France |
| Contact telephone number: | [phone] JAN 1 4 2002 |
| Contact person: | Joanna Droege |
| Date summary prepared: | October 8, 2001 |
| Trade or proprietary device name: | Anterior Cervical Plate System |
| Common or usual name: | Anterior cervical plating system |
| Classification name: | Class II |
| Legally marketed predicate device: | Sofamor Danek – Orion System<br>DePuy - DePuy Motech PEAK |

#### (4) Subject device description:

The Anterior Cervical Plate System consists of multiple sized plates and screws. All components are manufactured from titanium alloy (Ti-6A1-4V) that conform to ASTM F136.

#### Subiect device intended use: (5)

The Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of a solid spinal fusion in patients with neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies (DDD), trauma (i.e. fractures), tumors, deformities (i.e. kyphosis, lordosis, and scoliosis), pseudoarthrosis, spinal stenosis, and failed previous fusions.

WARNING: These devices are not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

#### Performance data: (6)

The Food and Drug Administration have established no performance standards applicable to anterior cervical plating systems. However, static and fatigue compression and static torsion testing of the Anterior Cervical Plate System were performed according to ASTM F1717-96.

#### Basis for substantial equivalence: (7)

The Anterior Cervical Plate System has similar design characteristics, i.e., material, screw size, and indications, as the Orion (K973854) and PEAK System (K971730) systems distributed by Sofamor Danek and DePuy Motech, respectively.

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Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JAN 1 4 2002

Ms. Joanna Droege Scient'X c/o Encore Orthopaedics 9800 Metric Boulevard Austin Texas 78758

Re: K013439

> Trade Name: Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: II Product Code: K WQ Dated: October 15, 2001 Received: October 17, 2001

Dear Ms. Droege:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (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.

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Page 2 - Ms. Joanna Droege

This letter will allow you to begin marketing your device as described in your 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 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 at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Mark M Mullener

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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510(k) Number (if known):

Device Name: __ Anterior Cervical Plate System

Indications For Use:

# Anterior Cervical Plate System

### Indications For Use

The Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of a solid spinal fusion in patients with neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies (DDD), trauma (i.e. fractures), tumors, deformities (i.e. kyphosis, lordosis, and scoliosis), pseudoarthrosis, spinal stenosis, and failed previous fusions.

WARNING: These devices are 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)

ision of General, Restorative and Non Jogical Devices ાર્ડ તાલુકાઓ પૈકીના એક એવા ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામનાં લોકોનો મુખ્ય 510(k) Number -OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ Prescription Use (per 21 CFR 801.109) (Optional Format 1-2-96)_

## OK

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