# K981715: Distal Radius Fracture Fixation Plate

- Pathway: 510(k) (Traditional)
- Applicant: Avanta Orthopaedics, Inc.
- Decided: Jul 29, 1998 after 75 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: 1 generation back to K943853 (1995). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
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.

## Most influential descendants
- K990596: Distal Radius Fracture Fixation Plate System (1999), 0 descendants of its own

## 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/K981715
Methodology: https://510kreport.com/methodology