# K212872: Avenger Radial Head System

- Pathway: 510(k) (Traditional)
- Applicant: In2bones USA, LLC
- Decided: Dec 17, 2021 after 99 days
- Product code: KWI (Prosthesis, Elbow, Hemi-, Radial, Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3170
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K944507 (1995). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192754: Avenger Radial Head System, In2bones USA, LLC (2020) Summary page 5.
- K991915: Modular Radial Head, Wrightmedicaltechnologyinc (1999) Summary page 5.
- K060731: Evolve Modular Radial Head, Wrightmedicaltechnologyinc (2006) Summary page 5.

## Indications for use
The Avenger Radial Head System is intended for replacement of the proximal end of the radius: * Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at radial-humeral and/or proximal radio-ulnar joint with: a. Joint destruction and/or subluxation visible on x-ray; and/or b. Resistance to conservative treatment. * Primary replacement after fracture of the radial head. » Symptomatic sequelae after radial head resection. * Revision following failed radial head arthroplasty. The components are intended for uncemented use.

Source page: https://510kreport.com/device/K212872
Methodology: https://510kreport.com/methodology