PREVIEW ANTERIOR CERVICAL PLATE SYSTEM

K062371 · Alphaspine, Inc. · KWQ · Dec 4, 2006 · Orthopedic

Device Facts

• Record ID: K062371
• Device Name: PREVIEW ANTERIOR CERVICAL PLATE SYSTEM
• Applicant: Alphaspine, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: Dec 4, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PreView™ Anterior Ccrvical Plate System is intended for the treatment of the cervical spine in skeletally mature patients.receiving fusion-by autogenous and/or allogenic bone graft. The implants are attached to the anterior cervical spine (C2-T1) with removal of the implants after the attainment of a solid fusion mass. The PreView™ Anterior Cervical Plate System is intended for use under the following indications: · Degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) • Spondylolisthesis - · Trauma (i.e., fracture or dislocation) · Spinal stenosis - · Deformitics or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) • Tumor - Pseudoarthrosis - · Failed previous fusion

Device Story

PreView Anterior Cervical Plate System is a spinal intervertebral body fixation orthosis. Device consists of plates and screws attached to anterior cervical spine (C2-T1) to provide stabilization during fusion process. Used by surgeons in clinical/OR settings. Implants are intended for removal after solid fusion mass is achieved. Benefits include stabilization of cervical spine segments to facilitate bone healing in patients with degenerative, traumatic, or neoplastic conditions.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and design characteristics.

Technological Characteristics

Spinal intervertebral body fixation orthosis (21 CFR 888.3060). System comprises plates and screws for anterior cervical fixation. Metallic construction. Mechanical fixation device.

Indications for Use

Indicated for skeletally mature patients requiring cervical spine fusion (C2-T1) using autogenous/allogenic bone graft for degenerative disc disease, spondylolisthesis, trauma (fracture/dislocation), spinal stenosis, deformities (scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, or 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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Alphaspine, Incorporated c/o Mr. Mike Ensign Regulatory Manager 765 E 340 S Suite 204 American Fork, Utah 84003-3348

DEC - 4 2006

Re: K062371

Trade Name: PreView™ Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWO Dated: October 11, 2006 Received: October 13, 2006

Dear Mr. Ensign:

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.

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Page 2 - Mr. Mike Ensign

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. 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 Parl 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/industry/support/index.html.

Sincerely vours.

Barbara Buchuns
for

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: PreView Anterior Cervical Plate System

Indications for Use:

The PreView™ Anterior Ccrvical Plate System is intended for the treatment of the cervical spine in skeletally mature patients.receiving fusion-by autogenous and/or allogenic bone graft. The implants are attached to the anterior cervical spine (C2-T1) with removal of the

implants after the attainment of a solid fusion mass. The PreView™ Anterior Cervical Plate System is intended for use under the following indications: )

· Degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)

• Spondylolisthesis

- · Trauma (i.e., fracture or dislocation)
· Spinal stenosis

- · Deformitics or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
• Tumor

- Pseudoarthrosis
- · Failed previous fusion

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

4

Soubane Friedrichs Ar. ukn

(Division Sign-Of Division of Genera Restorative, and Neurological Lences

510(k) Number K062371