# K982982: Mini-Fixator for Colles Fractures

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Oct 13, 1998 after 48 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.
6 later devices descend from it; 1 cites it directly.
0 of 7 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 DePuy device: named in the summary without a submission number
- (no number) Trend Medical device: named in the summary without a submission number
- (no number) Zimmer device: named in the summary without a submission number
- (no number) OrthoFrame device: named in the summary without a submission number
- (no number) SE device: named in the summary without a submission number

## Most influential descendants
- K984498: Synthes (Usa) Articulating Distal Radius (Adrf) System (1999), 5 descendants of its own
- K012294: Wristore Fixator (2002), 3 descendants of its own
- K042761: Wristore Distal Radius Fracture Fixator, 4600 Series (2004), 1 descendant of its own
- K101338: Newfix External Fixation System (2011), 0 descendants of its own
- K052498: Fragment Specific Fixator (2005), 0 descendants of its own

## Indications for use
The Mini-Fixator for Colles Fractures is intended for use in the repair of Colles fractures. The device is intended for single use only and is external with internal pins.

Source page: https://510kreport.com/device/K982982
Methodology: https://510kreport.com/methodology