EBI ANTERIOR CERVICAL SPINE SYSTEM

K955730 · Electro-Biology, Inc. · KWQ · Mar 13, 1996 · Orthopedic

Device Facts

• Record ID: K955730
• Device Name: EBI ANTERIOR CERVICAL SPINE SYSTEM
• Applicant: Electro-Biology, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: Mar 13, 1996
• Decision: SN
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The EBI Anterior Cervical Spine System is a single use device, intended for anterior cervical spine applications only. Specific indications include the fusion, reduction, alignment or stabilization of the cervical segments of the spine in cases of degenerative disc disease (spondylosis of the cervical spine, cervical spondylotic myelopathy and cervical spondylosis neuropathy), trauma, and tumors.

Device Story

System consists of spinal implant components (plates, screws, locking screws) and surgical instruments; used for anterior cervical spine stabilization. Implants fabricated from Ti-6Al-4V ELI alloy with optional Titanium Nitride (TiN) coating. Device implanted by surgeons in clinical/OR setting to facilitate spinal fusion, reduction, or alignment. Output is mechanical stabilization of cervical segments. Benefits include structural support for bone healing in degenerative, traumatic, or oncological conditions.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Materials: Ti-6Al-4V ELI alloy with optional Titanium Nitride (TiN) coating. Components: plates, screws, locking screws. Intended for single use.

Indications for Use

Indicated for patients requiring fusion, reduction, alignment, or stabilization of cervical spine segments due to degenerative disc disease (spondylosis, myelopathy, neuropathy), trauma, or tumors.

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

• Cervical Spine Locking Plate (Synthes)
• Songer Titanium Cable System (Sofamor Danek)
• Buechel-Pappas™ Total Hip Replacement System (Endotec, Inc.)

Submission Summary (Full Text)

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EBI Electro Biology

K955730

Enhancing Bone Healing through Applied Science

Summary of Safety & Effectiveness for EBI Anterior Cervical Spine System

This Safety and Effectiveness Summary for the EBI* Anterior Cervical Spine System line extension to include TiN coating is provided as required per Section 513(i)(3) of the Food, Drug and Cosmetic Act.

1. Submitter: Electro-Biology Inc. Contact Person: Sharon A. Starowicz
6 Upper Pond Road
Parsippany, NJ 07054
Telephone: [phone]

Date prepared: December 15, 1995

2. Proprietary Name: EBI* Anterior Cervical Spine System
Common Name: Spinal Fixation System

Classification Name: Spinal Intervertebral Body Fixation Orthosis

3. Predicate or legally marketed devices with TiN coating that are substantially equivalent:

- Cervical Spine Locking Plate distributed by Synthes
- Songer Titanium Cable System distributed by Sofamor Danek
- Buechel-Pappas™ Total Hip Replacement System distributed by Endotec, Inc.

4. Description of the device: The EBI Anterior Cervical Spine System consists of spinal implant components and various instruments used during the implantation procedure. The spinal implants consist of plates, screws and locking screws.

Materials: Ti-6Al-4V ELI alloy with or without Titanium nitride coating

5. Intended Use: The EBI Anterior Cervical Spine System is a single use device, intended for anterior cervical spine applications only. Specific indications include the fusion, reduction, alignment or stabilization of the cervical segments of the spine in cases of degenerative disc disease (spondylosis of the cervical spine, cervical spondylotic myelopathy and cervical spondylosis neuropathy), trauma, and tumors.

6. Comparison of the technological characteristics of the device to predicate and legally marketed devices:

There are no significant differences between the TiN coating of the EBI* Anterior Cervical Spine System and the other currently marketed TiN coated orthopedic implants which would adversely affect the use of the product. It is substantially equivalent* to these other devices in function, material and chemical composition.

*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 intended to be 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.)]

Electro-Biology, Inc. - A Subsidiary of Biomet, Inc.

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