FDA applicant
Biomet Microfixation
FDA records 31 decisions for Biomet Microfixation (Jacksonville, FL) from 2005 to 2026: 30 510(k) clearances and 1 original PMA approval. Most are in product codes HRS (Plate, Fixation, Bone) and JEY (Plate, Bone). Since 2016 its 510(k)s took a median of 98 days from receipt to decision, against 109 for FDA’s reviews in the same codes and years. Its devices cite 58 predicates, 18 of them its own earlier devices. 22 recalls are linked to its devices.
FDA’s records also spell it “Biomet Microfixation, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Biomet Microfixation’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
1in 2017
Class I Class II/III not classified
Planning a device like Biomet Microfixation’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) ReportOther applicant names beginning “Biomet”
FDA records each applicant name separately; these may or may not be the same firm.