# K103001: Rockwood Clavicle Pins

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Feb 17, 2011 after 134 days
- Product code: JDW (Pin, Fixation, Threaded)
- 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
Longest line of descent: 2 generations back to K903258 (1990). 4 ancestors in all.
7 later devices descend from it; 4 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)
- K991649: Depuy Rockwood Clavicle Pin, Depuy, Inc. (1999) Summary page 1.

## Most influential descendants
- K143204: AOS Clavicle Intramedullary Device (2015), 2 descendants of its own
- K163488: Flex-Thread Clavicle Pin System (2017), 1 descendant of its own
- K111663: Trauma Internal Fixation Systems (2012), 1 descendant of its own
- K243761: A.L.P.S. Small Fragment Plating System (2025), 0 descendants of its own
- K242896: Caliber Intramedullary Fixation System (2025), 0 descendants of its own

## Indications for use
The DePuy Rockwood Clavicle Pin is intended to be used to repair an acute fracture, mal-union or non-union of the clavicle.

Source page: https://510kreport.com/device/K103001
Methodology: https://510kreport.com/methodology