# K042766: Orthofix Volar Distal Radial Plate

- Pathway: 510(k) (Traditional)
- Applicant: Orthofix, Inc.
- Decided: Nov 16, 2004 after 42 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: 3 generations back to K885250 (1989). 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)
- K040112: Trimed Bearing Plate; Trimed Volar Bearing Plate, Tri-Med, Inc. (2004) Summary page 2.
- K040022: Stryker Leibinger Universal Distal Radius System, Stryker Leibinger (2004) Summary page 2.

## Most influential descendants
- K101936: Contours VSP Iii Volar Plating System (2010), 0 descendants of its own

## Indications for use
The Orthofix Volar Distal Radial Plate is intended for the volar fixation of fractures and osteotomies involving the distal radius.

Source page: https://510kreport.com/device/K042766
Methodology: https://510kreport.com/methodology