# K030198: Hand Innovations, Inc. Distal Radius Fracture Repair System

- Pathway: 510(k) (Traditional)
- Applicant: Hand Innovations, Inc.
- Decided: Apr 1, 2003 after 70 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 K962616 (1996). 5 ancestors in all.
678 later devices descend from it; 4 cite it directly.
1 of 684 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023007: Distal Radius Fracture Repair System, Hand Innovations, Inc. (2002) Summary page 1.

## Most influential descendants
- 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
- K090675: Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories (2009), 487 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.

Source page: https://510kreport.com/device/K030198
Methodology: https://510kreport.com/methodology