NEXT GENERATION ANTERIOR CERVICAL PLATING SYSTEM

K070681 · Alphatec Spine, Inc. · KWQ · May 4, 2007 · Orthopedic

Device Facts

• Record ID: K070681
• Device Name: NEXT GENERATION ANTERIOR CERVICAL PLATING SYSTEM
• Applicant: Alphatec Spine, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: May 4, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

It is intended that this device, in any system configuration, be removed after the development of solid fusion mass of spinal segments in skeletally mature patients. The NEXT GENERATION™ Anterior Cervical Plate system is intended for use in anterior cervical decompression and fusion (ACDF) surgery (C2-C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of fusion in patients with the following conditions: degenerative disc disease(DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) spondylolisthesis trauma (i.e., fracture or dislocation) spinal stenosis tumor pseudoarthrosis and failed previous fusion.

Device Story

Anterior cervical plating system consisting of plates, screws, and instrumentation; used in ACDF surgery (C2-C7) for temporary stabilization of the anterior spine. Device provides mechanical support to facilitate spinal fusion; intended for removal after solid fusion mass develops. Operated by surgeons in clinical/OR settings. Benefits include stabilization of spinal segments during healing process for patients with degenerative, traumatic, or neoplastic conditions.

Clinical Evidence

No clinical data. Substantial equivalence supported by mechanical and dynamic bench testing.

Technological Characteristics

Anterior cervical plating system comprising plates and screws. Mechanical fixation device. No software or electronic components.

Indications for Use

Indicated for skeletally mature patients undergoing anterior cervical decompression and fusion (C2-C7) requiring temporary stabilization during fusion. Conditions include degenerative disc disease, spondylolisthesis, trauma (fracture/dislocation), spinal stenosis, tumor, pseudoarthrosis, and failed previous fusion.

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

• CSLP (K000536)
• Stella (K042317)

Submission Summary (Full Text)

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Alphatec Spine NEXT GENERATION™ Cervical Plate System

510(k) Number K07068/

# 510(k) SUMMARY

# NEXT GENERATION™ Anterior Cervical Plating System 510(k) SUMMARY March 2007

MAY - 4 2007

| Company: | Alphatec Spine, Inc.<br>2051 Palomar Airport Road#100<br>Carlsbad, CA 92011 USA<br>Telephone: [phone]<br>Fax: [phone] |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Paula Morgan, Director of Regulatory Affairs |
| Trade/Proprietary Name: | NEXT GENERATION™ Anterior Cervical Plating System |
| Common Name: | Anterior Cervical plate System |
| Classification Name: | Spinal Intervertebral body fixation Orthosis (888.3060) |

### Product Description:

The NEXT GENERATION™ Anterior Cervical Plating System is an anterior cervical plating system intended for use in anterior cervical decompression and fusion (ACDF) surgery (C2-C7). The subject components of this submission are cervical plates, screws, and various instrumentation.

#### Indications for Use:

It is intended that this device, in any system configuration, be removed after the development of solid fusion mass of spinal segments in skeletally mature patients.

The NEXT GENERATION™ Anterior Cervical Plate system is intended for use in anterior cervical decompression and fusion (ACDF) surgery (C2-C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of fusion in patients with the following conditions:

- degenerative disc disease(DDD) (defined as back pain of discogenic origin with degeneration . of the disc confirmed by history and radiographic studies)
- 트 spondvlolisthesis
- . trauma (i.e., fracture or dislocation)
- 지 spinal stenosis
- 트 tumor
- 미 pseudoarthrosis
- 체 and failed previous fusion.

Confidential and Proprietary

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## Substantial Equivalence:

The NEXT GENERATION™ Anterior Cervical Plating System is substantially equivalent to the following predicate devices:

| Trade/Proprietary Name | Manufacturer | Clearance |
|------------------------|---------------|-----------|
| CSLP | Synthes Spine | K000536 |
| Stella | Scient'x | K042317 |

## Performance Data:

Mechanical and dynamic testing of the cervical plate system was performed. The test results demonstrate that the mechanical performance of the NEXT GENERATION™ Anterior Cervical Plating System is substantially equivalent to the predicate devices.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Alphatec Spine, Inc. % Ms. Paula Morgan Director of Regulatory Affairs & Compliance 2051 Palomar Airport Road, Suite 100 Carlsbad, California 92011

MAY - 4 2007

Re: K070681

Trade Name: NEXT GENERATION™ Anterior Cervical Plate System Regulation Number(s): 21 CFR 888.3060 Regulation Names: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: April 20, 2007 Received: April 25, 2007

Dear Ms. Morgan:

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 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) application. You may, therefore, market the device, subject to the general controls (1 mil) appliethe Act and the limitations described below. 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. Paula Morgan

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 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/industry/support/index.html.

Sincerely vours.

Harbaye Muehlup

Mark N. Melkerson 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

#### 510(k) Number (if known):

Device Name: NEXT GENERATION™ Anterior Cervical Plating System

#### Indications for Use:

It is intended that this device, in any system configuration, be removed after the development of solid fusion mass of spinal segments in skeletally mature patients.

The NEXT GENERATION™ Anterior Cervical Plate system is intended for use in anterior cervical decompression and fusion (ACDF) surgery (C2-C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of fusion in patients with the following conditions:

- degenerative disc disease(DDD) (defined as back pain of discogenic origin with I degeneration of the disc confirmed by history and radiographic studies)
- 트 spondylolisthesis
- trauma (i.e., fracture or dislocation) . ■
- 에 spinal stenosis
- pseudoarthrosis 예
- 트 tumor
- and failed previous fusion.

Prescription Use (Per 21 CFR 801.109) OR

Over-The Counter Use

(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Oarlare Buend

Division of General, Restorative, and Neurological Devices

Confidential and Propriatio(k) Number_

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