K963350 · Depuy, Inc. · HWC · Nov 14, 1996 · Orthopedic
Device Facts
Record ID
K963350
Device Name
DEPUY MOTECH PEAK FIXATION SYSTEM
Applicant
Depuy, Inc.
Product Code
HWC · Orthopedic
Decision Date
Nov 14, 1996
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 888.3040
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The DePuy Motech PEAK Fixation System is intended for use in treating fractures of small bones such as the metacarpals, ulna, radius, humerus and metatarsals and in treating fractures of the lateral malleolus, olecranon, and intra-articular distal tibia.
Device Story
Bone fixation system for small bone fractures; consists of channeled reconstruction plates (26-104mm), 3.5mm cortical screws (16-30mm), and steplock washers. Plates feature tooth pattern on outer surface to interlock with washer tabs. Used by orthopedic surgeons in clinical/surgical settings to stabilize fractures. Provides mechanical fixation to facilitate bone healing.
Clinical Evidence
Bench testing only; 4-point bending tests compared rigidity, strength, and stiffness against predicate devices.
Indicated for patients with fractures of small bones including metacarpals, ulna, radius, humerus, metatarsals, lateral malleolus, olecranon, and intra-articular distal tibia.
Regulatory Classification
Identification
A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.
Predicate Devices
ACE 100° Tubular Plate
Synthes (USA) LC-DCP Plate Set System
Synthes (USA) 1/3 Tubular Stainless Steel Plates
Submission Summary (Full Text)
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# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
## K96 3350
| NAME OF FIRM: | DePuy Inc.
700 Orthopaedic Drive
Warsaw, Indiana 46581-0988 | NOV 14 1996 |
| --- | --- | --- |
| 510(K) CONTACT: | Cheryl Hastings
Manager, Clinical Affairs | |
| TRADE NAME: | DePuy Motech PEAK Fixation System | |
| COMMON NAME: | Bone Plate | |
| CLASSIFICATION: | 888.3030 Single/multiple component metallic bone fixation appliance and accessories | |
| DEVICE PRODUCT CODE: | Product code: 87 HRS | |
| SUBSTANTIALLY EQUIVALENT DEVICES: | ► ACE 100° Tubular Plate
► Synthes (USA) LC-DCP Plate Set System
► Synthes (USA) 1/3 Tubular Stainless Steel Plates | |
## INTENDED USE AND DEVICE DESCRIPTION:
The DePuy Motech PEAK Fixation System is intended for use in treating fractures of small bones such as the metacarpals, ulna, radius, humerus and metatarsals and in treating fractures of the lateral malleolus, olecranon, and intra-articular distal tibia. The system consists of 5 sizes of channeled reconstruction plates ranging from 26mm to 104mm in length, 13 sizes of 3.5mm cortical screws ranging from 16 to 30mm in length and a steplock washer. The reconstruction plates are 3mm thick and 9mm wide. All plates incorporate a tooth pattern, on one outer surface. The teeth are designed to interlock with the "tabs" on the steplock washer.
## BASIS OF SUBSTANTIAL EQUIVALENCE:
The DePuy Motech PEAK Fixation System is similar in material, design and intended use to the ACE 100° Tubular Plate and the Synthes LC-DCP Plate Set System. All of these systems consist of CP Titanium bone plates and screws intended to treat fractures of small bones. The ACE plate has a length of 97mm, 8 holes, a width of approximately 9mm and a thickness of approximately 1.3mm and is intended to be used with cancellous screws with diameters of 4.0mm or less. The Synthes system contains plates with lengths from 25mm to 120mm with 2 to 10 screw holes per plate, and is designed to be used with 3.5mm cortical bone screws. The 3.5mm screws range in length from 10mm to 50mm.
Mechanical testing shows that in 4 point bending the rigidity, strength and stiffness of the DePuy Motech PEAK Fixation System channeled reconstruction plates exceed those of the ACE 100° Tubular Plate and Synthes 1/3 Tubular Stainless Steel Plates.
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