# K212601: DRPx Locking Distal Radius Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Orthopaedic Implant Company
- Decided: Apr 5, 2022 after 231 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: 5 generations back to K983495 (1998). 44 ancestors in all.
No later device cites it as a predicate yet.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202971: DRPx Locking Distal Radius Plate System, Orthopaedic Implant Company (2021) Summary page 4.
- K150675: Dorsal Spanning Plate, Skeletal Dynamics, LLC (2015) Summary page 4.
- K082807: Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded Indications, Synthes (Usa) (2008) Summary page 4.

## Indications for use
The DRPx Locking Distal Radius Plate System is indicated for the fixation of intra- and extra-articular fractures and osteotomies of the distal radius.

Source page: https://510kreport.com/device/K212601
Methodology: https://510kreport.com/methodology