EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM

K022419 · Ebi, L.P. · KWQ · Aug 12, 2002 · Orthopedic

Device Facts

• Record ID: K022419
• Device Name: EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM
• Applicant: Ebi, L.P.
• Product Code: KWQ · Orthopedic
• Decision Date: Aug 12, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The EBI® SpineLink™ Anterior Cervical Spinal System is intended for anterior interbody screw fixation of the cervical spine at levels C3-C7. The System is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, and/or failed previous fusions. Warning: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Device Story

Anterior cervical spinal fixation system; utilizes interconnecting links and screws for temporary stabilization during fusion. Submission adds 3.5mm diameter screw to existing system. Used by surgeons in clinical settings to stabilize spine; provides mechanical support during bone healing. Benefits include stabilization of cervical spine segments in patients with degenerative, traumatic, or neoplastic conditions.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Material: Ti-6Al-4V ELI per ASTM F136. Design: Anterior cervical spinal fixation system with interconnecting links and screws. Modification: Addition of 3.5mm diameter screw. Mechanical fixation principle.

Indications for Use

Indicated for patients requiring temporary anterior cervical spine stabilization (C3-C7) during fusion. Conditions include degenerative disc disease, trauma (fractures), tumors, deformity (kyphosis, lordosis, scoliosis), pseudarthrosis, and 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

• EBI® SpineLink™ Anterior Cervical Spinal System (K973923, K991092, K993822, K000513)

Submission Summary (Full Text)

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K022419 p1/2

# AUG 1 2 2002

### 510(k) Summary

This 510(k) Summary for the EBI® SpineLink™ Anterior Cervical Spinal System is provided as required per Section 513(3) of the Food, Drug and Cosmetic Act.

| 1. Submitter: | EBI, L.P.<br>100 Interpace Parkway<br>Parsippany, NJ 07054 | Contact Person: | Frederic Testa<br>Telephone: [phone], ext. 2208 |
|-----------------------|------------------------------------------------------------|-----------------|--------------------------------------------------------|
| Date prepared: | July 23, 2002 | | |
| 2. Proprietary Name: | EBI SpineLink Anterior Cervical Spinal System | | |
| Common Name: | Spinal Fixation Device | | |
| Classification Names: | Spinal Intervertebral Body Fixation Orthosis | | |

- 3. Predicate or legally marketed devices that are substantially equivalent:
- + EBI® SpineLink™ Anterior Cervical Spinal System (K973923, K991092, K993822, K000513)
- 4. Description of the device: The EBI SpineLink System is an anterior cervical spinal fixation device that uses interconnecting links. This submission is for the addition of a 3.5mm diameter screw to the existing System.
- 5. Intended Use: The EBI SpineLink Anterior Cervical Spinal System is intended for anterior interbody screw fixation of the cervical spine at levels C3-C7. The System is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin of the disc confirmed

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K022414 p²/₂

by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, and/or failed previous fusions.

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

- 6. Materials: The components of the System are manufactured from Ti-6A1-4V ELI per ASTM F136.
- 7. Comparison of the technological characteristics of the device to predicate devices: There are no significant differences between the modified EBI SpineLink Anterior Cervical Spinal System and the currently marketed System. It is substantially equivalent* to the predicate device in regards to intended use, materials, and function. Mechanical testing demonstrates that the device complies with applicable standards and meets all of its functional requirements.

^* Any statement made in conjunction with this submission regarding a determination of substantial equivalence to any other product is intended only to relate to whether the product can be lawfully marketed without pre-market approval or reclassification and is not interpreted as an admission or any other type of evidence in patent infringement litigation. [Establishment Registration and Premarket Notification Procedures, Final Regulation, Preamble, August 23, 1977, FR 42520 (Docket No. 76N-0355.)]

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# AUG 1 2 2002

Mr. Frederic Testa, RAC Regulatory Affairs Specialist EBI, L.P. 100 Interpace Parkway Parsippany, New Jersey 07054

Re: K022419

Trade/Device Name: EBI® Spinelink" Anterior Cervical Spinal System Regulatory Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWO Dated: July 23, 2002 Received: July 24, 2002

Dear Mr. Testa:

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 - Mr. Frederic Testa, RAC

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, 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/dsma/dsmamain.html

Sincerely yours,

Mark H. Willeson

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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### STATEMENT OF INDICATIONS FOR USE

Page of

510(k) Number (if known):

Device Name: EBI SpineLink™ Anterior Cervical Spinal System

The EBI® SpineLink™ Anterior Cervical Spinal System is intended for anterior interbody screw fixation of the cervical spine at levels C3-C7. The System is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, and/or failed previous fusions.

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

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OR

Over-The-Counter Use

Mark A. Mckenna
Division Sign-Off

on of General. Restorative and scurological Devices 510(k) Number _

(Optional Format 1-2-96)