SPINAL CONCEPTS, INC. ANT-CER DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM

K024326 · Spinal Concepts, Inc. · KWQ · Jan 23, 2003 · Orthopedic

Device Facts

• Record ID: K024326
• Device Name: SPINAL CONCEPTS, INC. ANT-CER DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM
• Applicant: Spinal Concepts, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: Jan 23, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Ant-Cer Anterior Cervical Plate System is indicated for use in the temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, deformity (i.e., scoliosis, kyphosis, lordosis), pseudarthrosis, and failed previous fusions.

Device Story

System consists of titanium alloy bone plates, screws, and surgical instruments for anterior cervical spine fixation. Plates feature integrated locking mechanism to prevent screw-backout; dynamic design allows uni-directional axial movement for postoperative load sharing between plate and graft. Used by surgeons in clinical settings to stabilize spine during fusion development. Benefits patient by providing temporary structural support to facilitate solid spinal fusion.

Clinical Evidence

Bench testing only. Mechanical testing performed in accordance with ASTM F-1717 to verify design changes.

Technological Characteristics

Materials: Titanium alloy (ASTM F-136). Components: Bone plates, screws, surgical instruments. Mechanism: Integrated locking mechanism for screws; dynamic plate system for uni-directional axial movement. Sterilization: Supplied sterile or non-sterile.

Indications for Use

Indicated for temporary stabilization of cervical spine (C2-C7) in patients with instability due to degenerative disc disease, trauma, tumor, spondylolisthesis, spinal stenosis, deformity (scoliosis, kyphosis, lordosis), pseudarthrosis, or failed previous fusions.

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

• Spinal Concepts SC-AcuFix Anterior Cervical Plate System (K990005 and K013979)

Submission Summary (Full Text)

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004326
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# Spinal Concepts, Inc. Ant-Cer Dynamic Anterior Cervical Plate Syste

## 510(k) Summary of Safety and Effectiveness

1649384

## SUBMITTED BY

Spinal Concepts, Inc. 5301 Riata Park Court, Bldg, F Austin, TX 78727

JAN 2 3 2003

## ESTABLISHMENT REGISTRATION NUMBER

CONTACT PERSON

Primary Lisa Peterson Regulatory Affairs Specialist

Phone: [phone] Fax: [phone]

December 20, 2002

### Alternate David Hooper, Ph.D. Director, Clinical and Regulatory Affairs Phone: [phone] Fax: [phone]

DATE PREPARED

CLASSIFICATION NAME

COMMON NAME

PROPRIETARY NAME

PREDICATE DEVICE

KWQ: Spinal Intervertebral Body Fixation Orthosis. Class II.

Spinal Fixation System

Ant-Cer Dynamic Anterior Cervical Plate System

Spinal Concepts SC-AcuFix Anterior Cervical Plate System. (K990005 and K013979). This is a design modification per established design control procedures.

#### DEVICE DESCRIPTION

The Ant-Cer Dynamic Anterior Cervical Plate System consists of bone plates, screws and surgical instruments. The screws are used to secure the plates to the vertebral bodies of the cervical spine through an anterior approach. The plates have an integrated locking mechanism that captures the screw upon full insertion, preventing screw-backout. The Ant-Cer system is a dynamic plate system that provides for uni-directional axial movement to ensure postoperative load sharing between the plate and graft. Plates and screws are manufactured from titanium alloy (ASTM F-136) and may be supplied sterile or non-sterile.

#### INDICATIONS

The Ant-Cer Dynamic Anterior Cervical Plate System is indicated for use in the temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), turnor, spondylolisthesis, spinal stenosis, deformity (i.e., scoliosis, lordosis), pseudarthrosis, and failed previous fusions.

#### MECHANICAL TEST DATA

Mechanical testing data, including data collected in accordance with ASTM 1717, was collected to verify that the design changes met established design requirements.

5301 Riata Park Court, Bldg. F Austin, Texas 78727

Spinal Concepts, Inc.

Phone: [phone] Fax: [phone]

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DEPARTMENT OF HEALTH & HUMAN SERVICES

### Public Health Service

JAN 2 3 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Spinal Concepts, Inc. Ms. Lisa Peterson Regulatory Affairs Specialist 12012 Technology Boulevard, Suite 100 Austin, Texas 78727

Re: K024326

Trade Name: Ant-Cer Dynamic Anterior Cervical Plate System Regulation Number: 21 CFR 888.3050 Regulation Name: Appliance, fixation, spinal intervertebral body Regulatory Class: II Product Code: KWQ Dated: December 20, 2002 Received: December 26, 2002

Dear Ms. Peterson:

We have reviewed your Section 510(k) premarket 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) 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. Lisa Peterson

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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.

Mark A. Milkerss

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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:

## INDICATIONS FOR USE STATEMENT

Page 1 of 1

510(k) Number (if known):

Device Name:

Spinal Concepts, Inc. Ant-Cer Anterior Cervical Plate System

Indications for Use: .

The Ant-Cer Anterior Cervical Plate System is indicated for use in the temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, deformity (i.e., scoliosis, kyphosis, lordosis), pseudarthrosis, and failed previous fusions.

Ken Mark H. Wilkerson

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

510(k) Number K024326

(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: (Optional Format 1-2-96)

ision Sign-Off) of General, Restorative rological Devices

in " "mber.