← Product Code [KWQ](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWQ) · K962486 # DEPUY MOTECH ANTERIOR COMPRESSION PLATE SYSTEM (K962486) _Depuy, Inc. · KWQ · Dec 27, 1996 · Orthopedic · SN_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWQ/K962486 ## Device Facts - **Applicant:** Depuy, Inc. - **Product Code:** [KWQ](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWQ.md) - **Decision Date:** Dec 27, 1996 - **Decision:** SN - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3060 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The DePuy Motech PEAK™ Anterior Compression Plate System is intended for use in the treatment of anterior cervical spine instability as a result of fractures, dislocations, subluxations, tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylosis or a previously failed cervical surgery. ## Device Story System consists of Ti-6Al-4V plates and screws for anterior cervical spine stabilization; plates available in 4 design segments and 3 lengths; screws available in 3.5mm cortical and 4.0mm cancellous variants. Used by surgeons in clinical settings to provide fixation for spinal instability; device provides mechanical support to stabilize cervical vertebrae; benefits patient by facilitating fusion and restoring spinal alignment. ## Clinical Evidence Bench testing only; fatigue strength testing performed to compare mechanical performance against predicate devices. ## Technological Characteristics Materials: Ti-6Al-4V alloy. Components: Bone plates and screws. Dimensions: 4 plate segments, 3 lengths; 3.5mm cortical and 4.0mm cancellous screws. Mechanical fixation principle. ## Regulatory 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 - Acromed AcroPlate Anterior Cervical System - Codman Anterior Cervical Plate System - Aesculap Caspar Cervical Plate ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 12/23/96 MON 11:37 FAX 219 267 7098 DePuy Clinical & Reguat 006 K962486 # 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS DEC 27 1996 **NAME OF FIRM:** DePuy Inc. 700 Orthopaedic Drive Warsaw, IN 46581-0988 **510(K) CONTACT:** Cheryl Hastings Manager, Clinical Affairs **TRADE NAME:** DePuy Motech PEAK™ Anterior Compression Plate System **COMMON NAME:** Anterior Cervical Plate **CLASSIFICATION:** 888.3060: Spinal intervertebral body fixation orthosis **PRODUCT CODE:** 87 KWQ **SUBSTANTIALLY EQUIVALENT DEVICES:** Acromed AcroPlate Anterior Cervical System Codman Anterior Cervical Plate System Aesculap Caspar Cervical Plate ## DEVICE DESCRIPTION AND INTENDED USE: The DePuy Motech PEAK™ Anterior Compression Plate System consists of 12 different Ti-6Al-4V plates. The plates are available in 4 design segments (1, 2, 3 or 4 "I" shaped segments), each being available in 3 lengths. The system also includes Ti-6Al-4V 3.5mm cortical and 4.0mm cancellous screws in 13 lengths. The DePuy Motech PEAK™ Anterior Compression Plate System is intended for use in the treatment of anterior cervical spine instability as a result of fractures, dislocations, subluxations, tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylosis or a previously failed cervical surgery. ## BASIS OF SUBSTANTIAL EQUIVALENCE: The DePuy Motech PEAK™ Anterior Compression Plate System is similar in material, design and intended use to the Acromed AcroPlate Anterior Cervical System, the Codman Anterior Cervical Plate System and the Aesculap Cervical Plate System. All of these systems consist of Ti-6Al-4V or CP Titanium bone plates and screws intended for anterior stabilization of the cervical spine. Mechanical testing indicates that the fatigue strength of the DePuy Motech PEAK™ Anterior Compression Plate is similar to that of the Acromed AcroPlate and is adequate for it’s intended use. --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWQ/K962486](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWQ/K962486) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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