# K002775: Distal Volar Radius Fracture Repair System

- Pathway: 510(k) (Traditional)
- Applicant: Hand Innovations, Inc.
- Decided: Dec 5, 2000 after 90 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.
719 later devices descend from it; 8 cite it directly.
1 of 720 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## 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

Source page: https://510kreport.com/device/K002775
Methodology: https://510kreport.com/methodology