# K022231: Normed Distal Radius Reconstruction System

- Pathway: 510(k) (Traditional)
- Applicant: Osteomedics, Inc.
- Decided: Sep 13, 2002 after 65 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.
5 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K151407: RECON system (2015), 4 descendants of its own
- K152312: RECON system-V-TEK-IVP Plates and Screws (2015), 2 descendants of its own
- K202657: Javelin Tailor's Bunion Fixation System (2020), 1 descendant of its own
- K260291: Vortex5 Tailor's Bunion Correction System (2026), 0 descendants of its own
- K151708: RECON system - Compression Screws (2016), 0 descendants of its own

## Indications for use
Normed Distal Radius Reconstruction System intended for use in internal fixation of small bones - primary the distal radius in the forearm such as, compression fractures, intra-articular fractures, displaced fractures and surgical reductions.

Source page: https://510kreport.com/device/K022231
Methodology: https://510kreport.com/methodology