Who is the manufacturer of DEPUY MOTECH ANTERIOR COMPRESSION PLATE SYSTEM?

Depuy, Inc. filed the 510(k) submission for DEPUY MOTECH ANTERIOR COMPRESSION PLATE SYSTEM (K962486).

What is the FDA product code for DEPUY MOTECH ANTERIOR COMPRESSION PLATE SYSTEM?

KWQ. It is classified under 21 CFR 888.3060 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for DEPUY MOTECH ANTERIOR COMPRESSION PLATE SYSTEM?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like DEPUY MOTECH ANTERIOR COMPRESSION PLATE SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

DEPUY MOTECH ANTERIOR COMPRESSION PLATE SYSTEM

Q: What are the predicate devices for DEPUY MOTECH ANTERIOR COMPRESSION PLATE SYSTEM?

Acromed AcroPlate Anterior Cervical System; Codman Anterior Cervical Plate System; Aesculap Caspar Cervical Plate.

K962486 · Depuy, Inc. · KWQ · Dec 27, 1996 · Orthopedic

Device Facts

Record ID	K962486
Device Name	DEPUY MOTECH ANTERIOR COMPRESSION PLATE SYSTEM
Applicant	Depuy, Inc.
Product Code	KWQ · Orthopedic
Decision Date	Dec 27, 1996
Decision	SN
Submission Type	Traditional
Regulation	21 CFR 888.3060
Device Class	Class 2
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.

Indications for Use

Indicated for patients with anterior cervical spine instability due to fractures, dislocations, subluxations, tumor, degenerative disc disease, spondylosis, or failed prior cervical surgery.

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

Acromed AcroPlate Anterior Cervical System
Codman Anterior Cervical Plate System
Aesculap Caspar Cervical Plate

Related Devices

K181562 — Curiteva Anterior Cervical Plate System · Curiteva, LLC · Aug 2, 2018
K013877 — CODMAN SLIM-LOC SYSTEM · Codman & Shurtleff, Inc. · Dec 19, 2001
K072703 — PIONEER SLIMFUSE ANTERIOR CERVICAL PLATING SYSTEM · Pioneer Surgical Technology · Jan 10, 2008
K152455 — Amendia Cervical Plate System · Amendia, Inc. · Oct 15, 2015
K971730 — DEPUY MOTECH PEAK POLYAXIAL ANTERIOR CERVICAL PLATE SYSTEM · Depuy, Inc. · Nov 3, 1997

Submission Summary (Full Text)

{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.