# K023007: Distal Radius Fracture Repair System

- Pathway: 510(k) (Traditional)
- Applicant: Hand Innovations, Inc.
- Decided: Dec 5, 2002 after 87 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: 2 generations back to K962616 (1996). 4 ancestors in all.
681 later devices descend from it; 4 cite it directly.
1 of 686 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982732: Synthes (Usa) Distal Radius Plate System (DRPS), Synthes (1998) Summary page 3.
- K002775: Distal Volar Radius Fracture Repair System, Hand Innovations, Inc. (2000) Summary page 1.

## Most influential descendants
- 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
- K071563: Peri-Loc Periarticular Locked Plating System (2007), 495 descendants of its own

## Indications for use
The Distal Radius Fracture Repair System is intended for the fixation of fractures and osteotomies involving the distal radius. This 510(k) submission will address the only the additional indicationfor use

Source page: https://510kreport.com/device/K023007
Methodology: https://510kreport.com/methodology