# K020819: Distal Radius Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Apr 22, 2002 after 40 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
Longest line of descent: 2 generations back to K792022 (1979). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974876: Bionx Distal Radius Screw, Bionx Implants, Inc. (1998) Summary page 1.
- K011522: Resorbable Bone Pins, Biomet, Inc. (2001) Summary page 1.

## Most influential descendants
- K052624: Inion Otps Biodegradable Distal Radius Plate (2005), 0 descendants of its own

## Indications for use
The Distal Radius Plating System is indicated for use in open reduction and internal fixation of Frykman type I-IV dorsally displaced Colles fractures, osteotomies, and carpal fusions of the distal radius in the presence of appropriate immobilization.

Source page: https://510kreport.com/device/K020819
Methodology: https://510kreport.com/methodology