# K090304: Waveon WRX Bone Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Sonoma Orthopedic Products, Inc.
- Decided: Aug 28, 2009 after 203 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: 7 generations back to K962616 (1996). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071809: Ensplintrx Bone Fixation System, Sonoma Orthopedic Products, Inc. (2008) Summary page 1.

## Indications for use
The WaveonTM WRx (WristRocketTM Distal Radius System) is intended to be used for the fixation of unstable distal radius fractures in which closed reduction is not suitable: * Joint destruction and/or subluxation visible on x-ray; * Osteotomy and repair of distal radius malunion with or without bone graft; * Non-displaced fractures. * Transverse fractures of the distal radius with or without comminution (e.g. AO classifications A2 and A3); * Transverse fractures of the distal radius with an extension into the joint with or without comminution (e.g. AO classification C2 and C1 respectively); * Failed fracture fixation with or without bone graft for the types of fractures above; * The above types of fractures (i.e. AO classifications non-displaced transverse, A2, A3, C1 and C2) in which reduction has been lost following fixation with percutaneous pins with or without an external fixator.

Source page: https://510kreport.com/device/K090304
Methodology: https://510kreport.com/methodology