FDA applicant

Miach Orthopaedics, Inc.

Westborough, MA3 decisions2020–20262 recalls

FDA records 3 decisions for Miach Orthopaedics, Inc. (Westborough, MA) from 2020 to 2026: 2 510(k) clearances and 1 De Novo grant. All are in product code QNI (Resorbable Implant For Anterior Cruciate…). Its devices cite 2 predicates, 2 of them its own earlier devices. 2 recalls are 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 Miach Orthopaedics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2020high 1 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

1in 2025

2020high 1 (2023) · low 0 (2020)2026

Class I Class II/III not classified

FIG. 1 — Miach Orthopaedics, Inc. by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Miach Orthopaedics, Inc.

Which product codes does it file in?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?