# K991649: Depuy Rockwood Clavicle Pin

- Pathway: 510(k) (Traditional)
- Applicant: Depuy, Inc.
- Decided: Jul 14, 1999 after 62 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: 1 generation back to K903258 (1990). 3 ancestors in all.
15 later devices descend from it; 6 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K903258: Hagie Pin, Onyx Medical Corp. (1990) Summary page 1.
- K905347: Hagie Pin, O'Tec Corp. (1991) Summary page 1.
- K983757: Syntec-Taichung Non-Sterile Knowles Pin, Models: for Hexagonal Collar: 2991-01/15,2992-01/15, for Square Collar:29992-01, Syntec Scientific Corp. (1998) Summary page 1.
- (no number) DePuy Hagie & Modified Hagie Pins (pre-enactment): named in the summary without a submission number
- (no number) DePuy Tibia Bolt (pre-enactment): named in the summary without a submission number

## Most influential descendants
- K103001: Rockwood Clavicle Pins (2011), 7 descendants of its own
- K081832: Ensplintcmx Clavicle Pin (2008), 4 descendants of its own
- K143204: AOS Clavicle Intramedullary Device (2015), 2 descendants of its own
- K130298: Biopro Kwick-Wire Universal Screw System (2013), 2 descendants of its own
- K100112: Somona CWG Clavicle Fracture Repair Device Model Sonoma CWG Xyyy (X=Dia, Yyy=Length-in MM) (2010), 2 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/K991649
Methodology: https://510kreport.com/methodology