MODIFICATION TO LIFE SPINE NEO ANTERIOR CERVICAL PLATE SYSTEM

K062831 · Life Spine · KWQ · Oct 19, 2006 · Orthopedic

Device Facts

• Record ID: K062831
• Device Name: MODIFICATION TO LIFE SPINE NEO ANTERIOR CERVICAL PLATE SYSTEM
• Applicant: Life Spine
• Product Code: KWQ · Orthopedic
• Decision Date: Oct 19, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NEO™ Anterior Cervical Plate is indicated for use in temporary stabilization of the anterior spine from C2 to T1 during the development of cervical spinal fusions 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 or scoliosis); 6. Tumors; 7. Pseudarthrosis; 8. Failed previous fusions. WARNING: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Device Story

NEO™ Anterior Cervical Plate is a spinal fixation system consisting of bone plates, screws, and locking tabs. Used by surgeons in clinical settings to provide temporary stabilization of the anterior cervical spine (C2-T1) during fusion procedures. Components are implanted to support the spine in patients with degenerative disc disease, trauma, deformity, or other specified pathologies. The device provides mechanical stability to facilitate bone fusion. It is supplied non-sterile and requires sterilization before use.

Clinical Evidence

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

Technological Characteristics

Constructed from titanium alloy (Ti 6AL-4V-ELI) per ASTM F136. System includes plates, screws, and locking tabs. Mechanical fixation device; non-sterile. No software or electronic components.

Indications for Use

Indicated for patients requiring temporary anterior cervical spine stabilization (C2-T1) during fusion for 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) fixation.

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

• NEO™ Anterior Cervical Plate System (K040844)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for "Life Spine". The word "Life" is in bold, and the word "Spine" is in a thinner font. There is a curved line under the word "Spine", and a registered trademark symbol to the right of the word "Spine".

K062831/

0C1 1 9 2006

| | Special 510(k) Summary of Safety and Effectiveness |
|----------------------|-------------------------------------------------------------------------------------------------------------------------|
| | Special 510(k) Summary - NEO™ Anterior Cervical Plate |
| Submitted By: | Life Spine<br>2400 Hassell Road, Suite 370<br>Hoffman Estates, IL 60169<br>Telephone: [phone]<br>Fax: [phone] |
| 510(k) Contact: | Erin Malloy<br>Life Spine<br>2400 Hassell Road, Suite 370<br>Hoffman Estates, IL 60169 |
| Date Prepared: | September 19, 2006 |
| Trade Name: | NEO™ Anterior Cervical Plate |
| Common Name: | Spinal Fixation System |
| Classification: | Spinal Invertertebral Body Fixation Orthosis<br>CFR 888.3060<br>Class II |
| Device Product Code: | KWQ |
| Predicate Device: | NEO™ Anterior Cervical Plate System K040844 and other<br>predicate devices |

### Device Description:

The NEO™ Anterior Cervical Plate consists of various sizes of anterior cervical bone plates, screws and screw locking tabs. Components are available in a variety of sizes to fit popient. anatomy. All components are manufactured from implant grade titanium alloy 6A1-4V EIJ per ASTM F-136. The NEO™ Anterior Cervical Plate components will be supplied clean and "NON-STERILE".

### Intended Use of the Device:

The NEO™ Anterior Cervical Plate is indicated for use in temporary stabilization of the anterior spine from C2 to T1 during the development of cervical spinal fusions 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);

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Image /page/1/Picture/0 description: The image shows the logo for Life Spine. The words "Life Spine" are written in a bold, sans-serif font. A curved line appears beneath the word "Spine", and a registered trademark symbol is located to the right of the word "Spine".

- 4. Spinal cord stenosis;
- 5. Deformity or curvatures (i.e. kyphosis, lordosis or scoliosis);
- 6. Tumors;
- 7. Pseudarthrosis;
- 8. Failed previous fusions.

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

### Material:

The NEO™ Anterior Cervical Plate is manufactured from medical grade titanium alloy described by ASTM F136 (Ti 6AL-4V-ELI).

## Performance Data:

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

# Substantial Equivalence:

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

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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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with stylized lines representing its wings and body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# OCT 1 9 2006

Life Spine LLC % Ms. Erin Malloy Project Engineer 2400 Hassell Road, Suite 370 Hoffman Estates, Illinois 60195

Re: K062831

Trade/Device Name: NEO™ Anterior Cervical Plate Regulation Number: 21 CFR 878.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: September 19, 2006 Received: September 20, 2006

Dear Ms. Malloy:

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.

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Page 2 - Ms. Erin Malloy

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to organ mailing of substantial equivalence of your device to a legally premits to the are 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 If you desire specific advice for Jour ac 11-07-20120. Also, please note the regulation entitled, Connact the Orities of Complanes as (21CFR Part 807.97). You may obtain 101501411118 by reference to presence to presensibilities under the Act from the Division of Small other general mionmation on your Corpumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely your

Y.C.
Mark N. Melkerson

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: NEOTM Anterior Cervical Plate System

The NEO™ 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 fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of disc confirmed by patient history and radiographic studies); spondylolisthesis; trauma (including fractures or dislocations); spinal cord stenosis; deformity or curvatures (i.e. kyphosis, lordosis or scoliosis); tumors: pseudarthrosis; and / or failed previous fusions.

WARNING: This device is not approved for screw attachment or fixation 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)

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

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