# K953644: Volar Distal Radius Plate

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Mar 8, 1996 after 217 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.
438 later devices descend from it; 7 cite it directly.
0 of 439 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) Synthes Small T-Plate: named in the summary without a submission number

## Most influential descendants
- K974876: Bionx Distal Radius Screw (1998), 419 descendants of its own
- K992947: Cannulated Smartscrew Models 224540C, 224570C (1999), 413 descendants of its own
- K012001: Smartscrew (2001), 337 descendants of its own
- K030900: Inion Otps Biodegradable Fixaton System (2003), 333 descendants of its own
- K043248: Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model AR-8921DS (2005), 306 descendants of its own

## Indications for use
Synthes Volar Distal Radius Plate is intended for fixation of fractures and osteotomies of the distal radius, applied to the volar aspect.

Source page: https://510kreport.com/device/K953644
Methodology: https://510kreport.com/methodology