# K980368: Depuy Motech Peak 3MM Fixation Rod System

- Pathway: 510(k) (Traditional)
- Applicant: Depuy, Inc.
- Decided: Apr 14, 1998 after 74 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
11 later devices descend from it; 2 cite it directly.
0 of 12 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 3.5 mm Reconstruction Plate: named in the summary without a submission number

## Most influential descendants
- K982483: Depuy Motech Peak Fixation System (1998), 10 descendants of its own
- 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

## Indications for use
The DePuy Motech PEAK 3mm Fixation Rod System is intended for use in treating fractures of the pelvis, acetabulum, clavicle, scapula, and distal humerus.

Source page: https://510kreport.com/device/K980368
Methodology: https://510kreport.com/methodology