LIFE SPINE NEO ANTERIOR CERVICAL PLATE SYSTEM

K040844 · Life Spine, LLC · KWQ · Jul 23, 2004 · Orthopedic

Device Facts

• Record ID: K040844
• Device Name: LIFE SPINE NEO ANTERIOR CERVICAL PLATE SYSTEM
• Applicant: Life Spine, LLC
• Product Code: KWQ · Orthopedic
• Decision Date: Jul 23, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NEO Anterior Cervical Plate System 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 scollosis); 6. Tumors: 7. Pseudarthrosis; 8. Failed previous fusions.

Device Story

NEO Anterior Cervical Plate System provides temporary stabilization of anterior cervical spine (C2-T1) during fusion. System comprises titanium alloy bone plates, screws, and locking tabs in various sizes to accommodate patient anatomy. Device is non-sterile, intended for surgical implantation by physicians. Mechanical stability achieved through rigid fixation of vertebral bodies. Static and fatigue testing confirms performance comparable to predicate systems. Device aids in spinal alignment and fusion, potentially reducing pain and restoring stability in patients with degenerative, traumatic, or deformity-related conditions.

Clinical Evidence

Bench testing only. Static and fatigue strength testing performed to compare mechanical properties against predicate devices. No clinical data provided.

Technological Characteristics

Materials: Titanium alloy 6Al-4V ELI per ASTM F-136. Components: Bone plates, screws, locking tabs. Form factor: Various sizes for patient anatomy. Sterilization: Supplied non-sterile. Energy source: None (mechanical fixation). Connectivity: None.

Indications for Use

Indicated for temporary stabilization of anterior cervical spine (C2-T1) to facilitate 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) 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

• Interpore Cross International Anterior Cervical Plate System (K002592)
• Howmedica Osteonics Corporation Reflex Anterior Cervical Plate System (K031702)

Submission Summary (Full Text)

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## Life Spine, LLC NEOTM Cervical Plating System 510(k) Summary of Safety and Effectiveness

KO<40844/
page 1 of 1

### 1. General Information

| Submitter Information: | Life Spine, LLC<br>11925 East 65th Street, Suite 4<br>Indianapolis, IN 46236<br>Phone: [phone] Fax: [phone] |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Company Registration Number: | 3004499989 |
| Date Summary Prepared: | March 31, 2004 |
| Classification Name: | KWQ 888.3060 - Spinal Interverterbal Body Fixation<br>Orthosis. Class II |
| Common or Usual Name: | Spinal Fixation System |
| Device Trade Name: | NEOTM Anterior Cervical Plate System |

#### 2. Predicate Devices

Interpore Cross International Anterior Cervical Plate System (K002592) and the Howmedica Osteonics Corporation Reflex Anterior Cervical Plate System (K031702).

### 3. Intended Use

The NEO Anterior Cervical Plate System 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 scollosis);
- 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.

### 4. Device Description

The NEO Anterior Cervical Plate System consists of various sizes of anterior cervical bone plates. screws and screw locking tabs. 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 NEO ACPS components will be supplied clean and "NON-STERILE".

### 5. Mechanical Testing

The results of the static and fatigue strength testing for the NEO Anterior Cervical Plate System demonstrate comparable mechanical properties to the predicate devices listed.

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Image /page/1/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is a stylized image of an eagle or other bird with three wing-like shapes extending from its body. The image is in black and white.

Public Health Service

JUL 2 3 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Michael S. Butler President Life Spine, LLC. 11965 East 65th Street, Suite 4 Indianapolis, Indiana 46236

Re: K040844

R0400++
Trade/Device Name: NEO™ Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: June 29, 2004 Received: June 30, 2004

Dear Mr. Butler:

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 for about of to May 28, 1976, the enactment date of the Medical Device Amendments, or to conniner of Prizer to Frid) 2011-07-12 11:12 provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmetic . Ior , 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 – Michael S. Butler

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will and in yourse FDA finding of substantial equivalence of your device to a legally premated notification " 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 11 you desire specific arrivally 3 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 other golferal micronational 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. Wilkerson

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

K040844 510(k) Number (if known):

Device Name: NEOTM Anterior Cervical Plate System

Indications for Use:

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 with degencrative 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: X
(Per 21 CFR 801.109)

Mark A Millman

Division of General, Restorative, and Neurological Devices

**510(k) Number** K040844

Over-the-Counter Use: (Optional Format 1-2-96)