# K982732: Synthes (Usa) Distal Radius Plate System (DRPS)

- Pathway: 510(k) (Traditional)
- Applicant: Synthes
- Decided: Oct 8, 1998 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: 1 generation back to K962616 (1996). 2 ancestors in all.
749 later devices descend from it; 9 cite it directly.
1 of 752 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962616: Synthes Dorsal Distal Radius Plate (DDRP) System, Synthes (Usa) (1996) Summary page 1.
- K963798: Synthes Titanium Alloy Volar Distal Radius Plate (TI Alloy VDRP) System, Synthes (Usa) (1996) Summary page 1.

## Most influential descendants
- 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
- K051735: Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity (2005), 584 descendants of its own

## Indications for use
Synthes Distal Radius Plate System is intended for fixation of fractures, osteotomies, including carpal fusions involving the distal radius applied to the volar and dorsal aspect.

Source page: https://510kreport.com/device/K982732
Methodology: https://510kreport.com/methodology