# K021182: Radiolucent Colles Compression/Distraction Bar

- Pathway: 510(k) (Special)
- Applicant: Biomet, Inc.
- Decided: May 13, 2002 after 28 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 K001760 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001760: Radiolucent Colles Fracture Kit, Biomet, Inc. (2000) Summary page 1.

## Indications for use
Stabilization of open and/or unstable fractures and where soft tissue injury may preclude the use of other fracture treatments such as IM Rodding, casting, and other means of internal fixation.

Source page: https://510kreport.com/device/K021182
Methodology: https://510kreport.com/methodology