# K963798: Synthes Titanium Alloy Volar Distal Radius Plate (TI Alloy VDRP) System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Nov 27, 1996 after 65 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.
756 later devices descend from it; 4 cite it directly.
1 of 757 devices in its family (counting itself) has 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 VDRP: named in the summary without a submission number
- (no number) Synthes STP: named in the summary without a submission number

## Most influential descendants
- K982732: Synthes (Usa) Distal Radius Plate System (DRPS) (1998), 749 descendants of its own
- K023007: Distal Radius Fracture Repair System (2002), 681 descendants of its own
- K030198: Hand Innovations, Inc. Distal Radius Fracture Repair System (2003), 678 descendants of its own
- K032705: Distal Radius Fracture Repair System (2003), 615 descendants of its own
- K050932: Distal Volar Radius Anatomical Plate System (2005), 606 descendants of its own

## Indications for use
Synthes Ti Alloy VDRP is intended for fixation of fractures and osteotomies of the distal radius, applied to the volar aspect.

Source page: https://510kreport.com/device/K963798
Methodology: https://510kreport.com/methodology