FDA applicant

Biomet Manufactuting Corp.

Warsaw, IN2 decisions2012–20140 recalls

FDA records 2 decisions for Biomet Manufactuting Corp. (Warsaw, IN) from 2012 to 2014: 2 510(k) clearances. Most are in product codes MBF (Prosthesis, Shoulder, Semi-Constrained…) and LPH (Prosthesis, Hip, Semi-Constrained…). Its devices cite 3 predicates, 0 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 Biomet Manufactuting Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Biomet Manufactuting Corp. by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Biomet Manufactuting Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Biomet”

FDA records each applicant name separately; these may or may not be the same firm.

Biomet, Inc. 446 Biomet Manufacturing Corp 129 Biomet Orthopedics, Inc. 41 Biomet 3i, Inc. 32 Biomet Microfixation 31 Biomet Spine 23 Biomet Sports Medicine 13 Biomet Spine (Aka Ebi, LLC) 13 Biomet Trauma 7 Biomet Trauma (Aka Ebi, Lp) 4 Biomet Micofixation 3 Biomet UK, Ltd. 3

Biomet Manufactuting Corp.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Biomet”