# K963350: Depuy Motech Peak Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Depuy, Inc.
- Decided: Nov 14, 1996 after 80 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
10 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) ACE 100° Tubular Plate: named in the summary without a submission number
- (no number) Synthes (USA) LC-DCP Plate Set System: named in the summary without a submission number
- (no number) Synthes (USA) 1/3 Tubular Stainless Steel Plates: named in the summary without a submission number

## Most influential descendants
- K190895: MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System, SYMPHONY OCT System, SUMMIT Fixation System (2019), 9 descendants of its own
- K200936: Invictus™ CT Spinal Fixation System (2020), 3 descendants of its own
- K192014: SYPMHONY™ OCT System (2020), 3 descendants of its own
- K192646: SYMPHONY™ OCT System (2020), 2 descendants of its own
- K252597: Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation) (2026), 1 descendant of its own

## 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.

Source page: https://510kreport.com/device/K963350
Methodology: https://510kreport.com/methodology