# BioPoly, LLC

- Location (FDA's records): Fort Wayne, IN
- FDA decisions: 3 (2021–2024): 3 510(k) clearances
- Product codes: KWD (2), KWI (1)
- Predicates its devices cite: 8 (3 its own); citations of its devices by later devices: 3 (3 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Vilex, LLC: 2 (https://510kreport.com/company/vilex)
- Vilex IN Tennessee, Inc.: 2 (https://510kreport.com/company/vilex-in-tennessee)
- Ignite Orthopedics, LLC: 1 (https://510kreport.com/company/ignite-orthopedics)

## Its most-cited devices
- K203634: BioPoly Great Toe Hemiarthroplasty Implant (2021), cited by 2
- K222964: BioPoly Lesser Toe Hemiarthroplasty Implant (2022), cited by 1

## Recent decisions
- K233592: BioPoly Radial Head Implant (Mar 13, 2024)
- K222964: BioPoly Lesser Toe Hemiarthroplasty Implant (Nov 22, 2022)
- K203634: BioPoly Great Toe Hemiarthroplasty Implant (Feb 2, 2021)

Source page: https://510kreport.com/company/biopoly