510(k) Report

FDA applicant

BioPoly, LLC

Fort Wayne, IN3 decisions2021–20240 recalls

FDA records 3 decisions for BioPoly, LLC (Fort Wayne, IN) from 2021 to 2024: 3 510(k) clearances. Most are in product codes KWD (Prosthesis, Toe, Hemi-, Phalangeal) and KWI (Prosthesis, Elbow, Hemi-, Radial, Polymer). Its devices cite 8 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided BioPoly, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2021: 12022: 12024: 1
2021high 1 (2021) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — BioPoly, LLC by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KWDProsthesis, Toe, Hemi-, Phalangeal2decisions
  • KWIProsthesis, Elbow, Hemi-, Radial, Polymer1decision

Whose devices does it build on?

Its devices cite 8 predicates; 3 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K203634BioPoly Great Toe Hemiarthroplasty ImplantBioPoly, LLC · 20212cite it
  • K222964BioPoly Lesser Toe Hemiarthroplasty ImplantBioPoly, LLC · 20221cites it

What has FDA decided for it lately?

  • K233592BioPoly Radial Head ImplantBioPoly, LLC · 2024
  • K222964BioPoly Lesser Toe Hemiarthroplasty ImplantBioPoly, LLC · 2022
  • K203634BioPoly Great Toe Hemiarthroplasty ImplantBioPoly, LLC · 2021

All 3 as BioPoly, LLC →