C3 ANTERIOR CERVICAL PLATE SYSTEM

K012881 · Spine Vision, Inc. · KWQ · Nov 26, 2001 · Orthopedic

Device Facts

• Record ID: K012881
• Device Name: C3 ANTERIOR CERVICAL PLATE SYSTEM
• Applicant: Spine Vision, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: Nov 26, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The C3™ Anterior Cervical Plate System is intended as a temporary internal fixation device used for the correction and stabilization of the cervical spine. The system is also intended to enhance the development of a solid fusion. The C3™ Anterior Cervical Plate System is indicated for trauma, deformity (lordosis, kyphosis and scoliosis), pseudoarthrosis, previously failed cervical spine fusion, tumor, degenerative disk disease (DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.) spondylolisthesis, and spinal stenosis. The C3™ Anterior Cervical Plate System is also indicated for stabilization of the spine from C2 to C7 during the time interval required for arthrodesis.

Device Story

C3 Anterior Cervical Plate System is a titanium alloy internal fixation device; consists of plates, screws, and locking set screws. Screws available in fixed-angle (rigid construct) and variable-angle (non-rigid construct) styles; hybrid constructs possible. Used by surgeons in clinical settings to stabilize cervical spine (C2-C7) during arthrodesis; facilitates solid fusion. Device provides mechanical support to correct/stabilize spine; benefits patient by maintaining alignment during bone healing process.

Clinical Evidence

Bench testing only. Static and fatigue testing performed to characterize stiffness, strength, and fatigue life.

Technological Characteristics

Titanium alloy construction; plate and screw system; fixed and variable angle screw options; locking set screws; manual surgical instrumentation; non-sterile (implied); mechanical fixation.

Indications for Use

Indicated for patients requiring cervical spine stabilization (C2-C7) due to trauma, deformity (lordosis, kyphosis, scoliosis), pseudoarthrosis, failed fusion, tumor, degenerative disc disease, spondylolisthesis, or spinal stenosis.

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 (USA) Synthes Spine Anterior CSLP (K000742)
• Synthes (USA) Titanium Locking Plate System (TILPS) (K970048)

Submission Summary (Full Text)

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K012881

## C3" Anterior Cervical Plate System

510 (k) Summary

SpineVision, Inc. Company: 3003 Summit Blvd., Suite 1500 Atlanta, GA 30319

NOV 2 6 2001

C3™ Anterior Cervical Plate System Trade Name:

Classification: KWQ 888.3060. Spinal Intervertebral Body Fixation Orthosis. Class II.

The C3 ... Anterior Cervical Plate System is a titanium alloy anterior cervical plate Description: The system consists of a number of plates and screws of fixation system. varying lengths and a variety of cover plates with locking set screws. Screws are available in different diameters, several lengths, and two different styles: fixed angle and variable angle. Fixed angle screws are used to build a rigid fixation construct. Variable angle screws are used to build a non-rigid construct. Hybrid constructs are possible by combining fixed and variable angle screws.

#### Performance Data:

### Non-clinical:

Static and fatigue testing was performed. Properties of stiffness, strength, and fatique life were characterized.

#### Intended Use:

The Carn Anterior Cervical Plate System is intended as a temporary internal fixation device used for the correction and stabilization of the cervical spine. The system is also intended to enhance the development of a solid fusion.

The C3™ Anterior Cervical Plate System is indicated for trauma, deformity (lordosis, kyphosis and scoliosis), pseudoarthrosis, previously failed cervical spine fusion, tumor, degenerative disk disease (DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.) spondylolisthesis, and spinal stenosis.

The Call Anterior Cervical Plate System is also indicated for stabilization of the spine from C2 to C7 during the time interval required for arthrodesis.

#### Substantial Equivalence:

Synthes (USA) Synthes Spine Anterior CSLP (K000742)

Synthes (USA) Titanium Locking Plate System (TILPS) (K970048)

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 6 2001

David W. Mullis, Jr., Ph.D., RAC Consultant for Spine Vision, Inc. Mullis & Associates, Inc .. Box 39 367 Pleasant Valley Road Good Hope, Georgia 30641

Re: K012881

Trade/Device Name: C3™ Anterior Cervical Plate System Regulatory Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: II Product Code: KWQ Dated: August 27, 2001 Received: August 28, 2001

Dear Dr. Mullis:

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 - David W. Mullis, Jr., Ph.D., RAC

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, (Jaase 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,

Susan Walker, us

Image /page/2/Picture/5 description: The image contains what appears to be a signature. The signature is written in cursive and is illegible. The signature is in black ink and is on a white background.

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: K012881

# Device Name: C3™ Anterior Cervical Plate System

### Intended Use:

The C3™ Anterior Cervical Plate System is intended as a temporary internal fixation device used for the correction and stabilization of the cervical spine. The system is also intended to enhance the development of a solid fusion.

The C3™ Anterior Cervical Plate System is indicated for trauma, deformity (lordosis, kyphosis and scoliosis), pseudoarthrosis, previously failed cervical spine fusion, tumor, degenerative disk disease (DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.) spondylolisthesis, and spinal stenosis.

The C3™ Anterior Cervical Plate System is also indicated for stabilization of the spine from C2 to C7 during the time interval required for arthrodesis.

(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)

OR

Over-The-Counter Use

(Optional Format 1-1-96)

Susan Walker

Division Sign-Off Division of General. Restorative and Neurological Devices

510(k) Number K012881