# K233592: BioPoly Radial Head Implant

- Pathway: 510(k) (Traditional)
- Applicant: BioPoly, LLC
- Decided: Mar 13, 2024 after 126 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: 12 generations back to K864492 (1987). 31 ancestors in all.
No later device cites it as a predicate yet.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183618: Revolution Radial Head, Ignite Orthopedics, Inc. (2019)
- K203634: BioPoly Great Toe Hemiarthroplasty Implant, BioPoly, LLC (2021) Summary page 4.
- K222964: BioPoly Lesser Toe Hemiarthroplasty Implant, BioPoly, LLC (2022) Summary page 4.

## Cited in the summary but kept off the family tree
- K132735: Axia Radial Head System, Imds (Innovative MEdical Device Systems) - Leis ME (2014). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The BioPoly Radial Head Implant is indicated for: * Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and or proximal radio-ulnar joint with: o joint destruction and/or subluxation visible on x-ray; and/or o resistance to conservative treatment * Primary replacement after fracture of the radial head » Symptomatic sequelae after radial head resection * Revision following failed radial head arthroplasty

Source page: https://510kreport.com/device/K233592
Methodology: https://510kreport.com/methodology