# K990596: Distal Radius Fracture Fixation Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Avanta Orthopaedics, Inc.
- Decided: Apr 29, 1999 after 64 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 K943853 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943853: Distal Radius Fracture Fixation Plate System, Wrightmedicaltechnologyinc (1995) Summary page 1.
- K953644: Volar Distal Radius Plate, Synthes (Usa) (1996) Summary page 1.
- K981715: Distal Radius Fracture Fixation Plate, Avanta Orthopaedics, Inc. (1998) Summary page 1.

## Indications for use
The intended use of the distal radius fracture fixation plate system is internal fixation of fractures and osteotomies of the distal radius. This may include: Displaced or non-displaced fracture which may or may not involve angulation or fragmentation of bone, Failed fracture fixation with or without bone graft, Osteotomy and repair of distal radius malunion with or without bone graft.

Source page: https://510kreport.com/device/K990596
Methodology: https://510kreport.com/methodology