← Product Code [HWC](/productcode/HWC) · K963350 # DEPUY MOTECH PEAK FIXATION SYSTEM (K963350) _Depuy, Inc. · HWC · Nov 14, 1996 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K963350 ## Device Facts - **Applicant:** Depuy, Inc. - **Product Code:** [HWC](/productcode/HWC.md) - **Decision Date:** Nov 14, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3040 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **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. ## Technological Characteristics Materials: CP Titanium. Components: Channeled reconstruction plates (3mm thick, 9mm wide), 3.5mm cortical screws, steplock washers. Design: Plates incorporate tooth pattern for interlocking with washer tabs. Mechanical performance: Exceeds rigidity/strength of predicate tubular plates. ## Regulatory 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) > 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} # 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. 1 --- **Source:** [https://fda.innolitics.com/device/K963350](https://fda.innolitics.com/device/K963350) **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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