# K203634: BioPoly Great Toe Hemiarthroplasty Implant

- Pathway: 510(k) (Traditional)
- Applicant: BioPoly, LLC
- Decided: Feb 2, 2021 after 53 days
- Product code: KWD (Prosthesis, Toe, Hemi-, Phalangeal)
- Device class: 2
- Regulation: 21 CFR 888.3730
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K864492 (1987). 26 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070052: Met-Head Model# MHDD-XX:CC Diameter, CC Cannulation, Vilex, Inc. (2007) Summary page 4.
- K190543: Cannulated Hemi Implant, Vilex IN Tennessee, Inc. (2019) Summary page 4.

## Most influential descendants
- K222964: BioPoly Lesser Toe Hemiarthroplasty Implant (2022), 1 descendant of its own
- K233592: BioPoly Radial Head Implant (2024), 0 descendants of its own

## Indications for use
The BioPoly Great Toe Hemiarthroplasty implant is intended to be implanted to replace the distal metatarsal surface of the great toe of patients with degenerative and post-traumatic arthritis in the first metatarsal joint in the presence of good bone stock along with the following clinical conditions: hallux valgus or hallux limitus, hallux rigidus, and an unstable or painful metatarsal/phalangeal (MTP) joint. The device is a single use implant intended to be used with bone cement.

Source page: https://510kreport.com/device/K203634
Methodology: https://510kreport.com/methodology