# K250498: BPS Wrist Fracture System

- Pathway: 510(k) (Special)
- Applicant: Orthonovis, Inc.
- Decided: Mar 17, 2025 after 25 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: 18 generations back to K792022 (1979). 147 ancestors in all.
No later device cites it as a predicate yet.
0 of 148 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242343: BPS Wrist Fracture System, Orthonovis, Inc. (2024) Summary page 5.
- K191641: AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius Plates, AFFINITY – Variable Angle Distal Radius Screws, Industrias Medicas Sampedro S.A.S (2019) Summary page 5.

## Indications for use
The BPS Wrist Fracture System is indicated for the fixation of simple and complex intra-articular and extra-articular fractures, and for osteotomies of the distal radius in adults. The device is indicated for fixation of Fractures AO types A2, A3, B1, B3, C1, C2, C3.

Source page: https://510kreport.com/device/K250498
Methodology: https://510kreport.com/methodology