SWIFT PLUS ANTERIOR CERVICAL PLATE SYSTEM
Device Facts
| Record ID | K072546 |
|---|---|
| Device Name | SWIFT PLUS ANTERIOR CERVICAL PLATE SYSTEM |
| Applicant | Depuy Spine, Inc. |
| Product Code | KWQ · Orthopedic |
| Decision Date | Oct 5, 2007 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 888.3060 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
The SWIFT™ Plus Anterior Cervical Plate System is intended for anterior cervical intervertebral body fixation. This system is indicated for patients in which stability is desired following anterior cervical fusion for the indications listed below. The intended levels for treatment range from C2 to T1. Indications include symptomatic cervical spondylosis, trauma, fracture, post-traumatic kyphosis or lordosis, tumor, degenerative disc disease (defined as pain with degeneration of the disc discogenic confirmed by history and radiographic studies), reoperation for failed fusion, or instability following surgery for the above indications.
Device Story
System consists of titanium alloy plates and screws for anterior cervical intervertebral body fixation; used by surgeons in clinical settings to provide stability following cervical fusion; device implanted to address symptomatic cervical spondylosis, trauma, tumors, or degenerative disc disease; provides mechanical stabilization of spinal segments C2-T1.
Clinical Evidence
Bench testing only; no clinical data provided.
Technological Characteristics
Manufactured from ASTM F-136 implant grade titanium alloy. System comprises plates and screws for spinal fixation. Manual surgical instruments included.
Indications for Use
Indicated for patients requiring anterior cervical intervertebral body fixation at levels C2-T1. Conditions include symptomatic cervical spondylosis, trauma, fracture, post-traumatic kyphosis/lordosis, tumor, degenerative disc disease, failed fusion reoperation, or post-surgical instability.
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
- SWIFT™ Anterior Cervical Plate System (K040655)
- EAGLE™ Plus Anterior Cervical Plate System (K070994)
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- K152282 — Cam Lock Plating System · Life Spine, Inc. · Nov 20, 2015
- K213443 — Insignia Anterior Cervical Plate System · Alphatec Spine, Inc. · Dec 15, 2021
- K080191 — EAGLE PLUS MICRO ANTERIOR CERVICAL PLATE SYSTEM · Depuy Spine, Inc. · Apr 2, 2008
