LIFE SPINE ANTERIOR CERVICAL PLATE SYSTEM

K070285 · Life Spine · KWQ · Mar 13, 2007 · Orthopedic

Device Facts

• Record ID: K070285
• Device Name: LIFE SPINE ANTERIOR CERVICAL PLATE SYSTEM
• Applicant: Life Spine
• Product Code: KWQ · Orthopedic
• Decision Date: Mar 13, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Life Spine Anterior Cervical Plate System is interior interbody screw fixation of the cervical spine. This system is indicated for use in temporary stabilization of the anterior spine from C2 to T1 during the development of a cervical spinal fusion in patients with: 1. Degenerative disease, DDD (as defined by neck pain of discogenic origin with degeneration of dise confirmed by patient history and radiographic studies); 2. Spondvlolisthesis 3. Trauma (including fractures or dislocations); 4. Spinal cord stenosis; 5. Deformity or curvatures (i.e. kyphosis, lordosis and/or scollosis); 6. Tumors: 7. Pseudarthrosis: 8. Failed previous fusions. Nota Benet This device system is intended for anterior cervical interverterbral body fusions only. WARNING: This device is not approved for serew attachment to the posterior clements (pedicles) of the cervical, thoracic, or lumbar spine.

Device Story

System consists of titanium alloy anterior cervical bone plates and screws; used for temporary stabilization of cervical spine (C2-T1) during fusion procedures. Components available in various sizes to accommodate patient anatomy. Device implanted by surgeons in clinical/OR settings. Provides mechanical fixation to support spinal fusion; intended for anterior intervertebral body use only. Not for posterior element attachment.

Clinical Evidence

Bench testing only. Biomechanical testing conducted in accordance with ASTM F1717 to demonstrate substantial equivalence.

Technological Characteristics

Materials: Implant grade titanium alloy 6Al-4V ELI (ASTM F136). Components: Anterior cervical bone plates and screws. Form factor: Various sizes for patient anatomy. Supplied non-sterile.

Indications for Use

Indicated for temporary stabilization of anterior cervical spine (C2-T1) during fusion in patients with degenerative disc disease, spondylolisthesis, trauma (fractures/dislocations), spinal cord stenosis, deformity (kyphosis, lordosis, scoliosis), tumors, pseudarthrosis, or failed previous fusions. Contraindicated for posterior element (pedicle) attachment.

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

• Life Spine NEO Cervical Plating System (K040844)
• Life Spine KINETIC Anterior Cervical Plate (K062643)

Submission Summary (Full Text)

{0}------------------------------------------------

070285

MAR 1 3 2007

## 510(k) Summary

## 510(k) Summary - Life Spine Anterior Cervical Plate System

| Submitted By: | Life Spine<br>2400 Hassell Road, Suite 370<br>Hoffman Estates, IL 60169<br>Telephone: [phone]<br>Fax: [phone] |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Rebecca M. Brooks<br>Life Spine<br>2400 Hassell Road, Suite 370<br>Hoffman Estates, IL 60195<br>Telephone: [phone]<br>Fax: [phone] |
| Date Prepared: | January 26, 2007 |
| Trade Name: | Life Spine Anterior Cervical Plate System |
| Common Name: | Spinal Fixation System |
| Classification: | KWQ 888.3060 - Spinal Intervertebral Body Fixation<br>Orthosis<br>21 CFR 888.3060<br>Class II |
| Device Product Code: | KWQ |
| Predicate Device: | Life Spine NEO ^™ Cervical Plating System K040844<br>Life Spine KINETIC ^® Anterior Cervical Plate K062643 |

## Device Description:

The Life Spine Anterior Cervical Plate consists of various sizes of anterior cervical bone plates and screws. Components are available in a variety of sizes to fit patient anatomy. All components are manufactured from implant grade titanium alloy 6A1-4V ELI per ASTM F-136. The Life Spine Anterior Cervical Plate components will be supplied clean and "NON-STERILE'.

{1}------------------------------------------------

070285 Page 2 of 2

## Intended Use of the Device:

The Life Spine Anterior Cervical Plate System is interior interbody screw fixation of the cervical spine. This system is indicated for use in temporary stabilization of the anterior spine from C2 to T1 during the development of a cervical spinal fusion in patients with:

- 1. Degenerative disease, DDD (as defined by neck pain of discogenic origin with degeneration of dise confirmed by patient history and radiographic studies);
- 2. Spondvlolisthesis
- 3. Trauma (including fractures or dislocations);
- 4. Spinal cord stenosis;
- 5. Deformity or curvatures (i.e. kyphosis, lordosis and/or scollosis);
- 6. Tumors:
- 7. Pseudarthrosis:
- 8. Failed previous fusions.

Nota Benet This device system is intended for anterior cervical interverterbral body fusions only.

WARNING: This device is not approved for serew attachment to the posterior clements (pedicles) of the cervical, thoracic, or lumbar spine.

#### Muterial:

The Life Spine Anterior Cervical Plate System is manufactured from medical grade itlanium alloy described by ASTM F136 (Ti 6A1-4V-ELI).

### Performance Data:

Biomechanical testing in accordance with ASTM F1717 was conducted to demonstrate substantial equivalence.

## Substantial Equivalence:

The Life Spine Anterior Cervical Plate System was shown to be substantially equivalent to previously cleared devices in indications for use, design, function, and materials used.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular pattern around the symbol. The caduceus is a common symbol associated with healthcare and medicine.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Life Spine LLC % Ms. Rebecca Brooks Project Coordinator 2400 Hassell Road, Suite 370 Hoffman Estates, Illinois 60195

MAR 1 3 2007

Re: K070285

Trade/Device Name: Life Spine Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWO Dated: January 26, 2007 Received: January 29, 2007

Dear Ms. Brooks:

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.

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.

{3}------------------------------------------------

## Page 2 - Ms. Rebecca Brooks

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). 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 yours,

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the words "Life Spine" in a bold, sans-serif font. The word "Life" is in a larger font size than the word "Spine". There is a registered trademark symbol next to the word "Spine". A curved line is underneath the words, adding a design element to the logo.

# Indications for Use

510(k) number (if known): _K070285

Device Name: Life Spine Anterior Cervical Plate System

The Life Spine Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. This system is indicated for use in temporary stabilization of the anterior spine from C2 to T1 during the development of a cervical spinal fusion in patients with (1) degenerative disc disease, DDD (as defined by neck pain of discogenic origin with degeneration of disc confirmed by patient history and radiographic studies), (2) spondylolisthesis, (3) trauma (including fractures or dislocations), (4) spinal cord stenosis, (5) deformity or curvatures (i.e. kyphosis, lordosis and/or scoliosis), (6) tumors, (7) pseudarthrosis, (8) failed previous fusions.

Nota Bene: This device system is intended for anterior cervical interverterbral body fusions only.

WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Prescription Use _x (Part 21 CFR 801 Subpart D) And/Or

Over-the-Counter Use (21 CFR 807 Subpart C)

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

Salvare Bonetur

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

510(k) Number K070285