ACPII ANTERIOR CERVICAL PLATE SYSTEM

K970806 · Sofamor Danek USA,Inc. · KWQ · May 2, 1997 · Orthopedic

Device Facts

• Record ID: K970806
• Device Name: ACPII ANTERIOR CERVICAL PLATE SYSTEM
• Applicant: Sofamor Danek USA,Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: May 2, 1997
• Decision: SN
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ACPii Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. 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 with degeneration 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.

Device Story

ACPii Anterior Cervical Plate System; spinal intervertebral body fixation orthosis. Components: bone plates with pre-assembled set screws and washers, bone screws, associated instruments. Surgical approach: anterior cervical spine. Function: temporary stabilization during fusion development. Used by surgeons in clinical/OR settings. Benefit: provides rigid fixation to facilitate spinal fusion in patients with degenerative disease, trauma, or deformity.

Clinical Evidence

No clinical data; mechanical test data provided.

Technological Characteristics

Materials: Titanium alloy (ASTM F-136). Components: Plates, pre-assembled set screws, washers, bone screws. Sterilization: Sterile or non-sterile. Form factor: Various shapes and sizes for anterior cervical fixation.

Indications for Use

Indicated for temporary stabilization of anterior cervical spine during fusion in patients with degenerative disc disease, trauma (fractures), tumors, deformity (kyphosis, lordosis, scoliosis), pseudarthrosis, or failed previous fusions. Contraindicated for posterior element (pedicle) attachment in cervical, thoracic, or lumbar spine.

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.

Submission Summary (Full Text)

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APR 29 '97 01:53PM SOFAMOR DANEK
5.34/34

# ACPii Anterior Cervical Plate System
510(k) Summary
K970806
MAY - 2 1997 April, 1997

I. **Company**: Sofamor Danek USA
1800 Pyramid Place
Memphis, Tennessee 38132
[phone]

II. **Product Name**: ACPii Anterior Cervical Plate System
**Classification Name**: Spinal intervertebral body fixation orthosis

III. The ACPii Anterior Cervical Plate System consists of a variety of shapes and sizes of bone plates (set screws and washers are pre-assembled to plates), screws and associated instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. The implant components will be made from titanium alloy as described by ASTM F-136 and may be supplied either sterile or non-sterile.

IV. The ACPii Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. 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 with degeneration 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.

V. The ACPii Anterior Cervical Plate System was claimed to be substantially equivalent to commercially available cervical plating systems. Literature concerning these devices was supplied in support of establishing equivalence.

Mechanical test data were provided in support of this notification.

© 1997 Sofamor Danek