510(k) Report

FDA applicant

Biomet Trauma

Parsippany, NJ7 decisions2007–20093 recalls

FDA records 7 decisions for Biomet Trauma (Parsippany, NJ) from 2007 to 2009: 7 510(k) clearances. Most are in product codes HRS (Plate, Fixation, Bone) and HSB (Rod, Fixation, Intramedullary And Accessories). Its devices cite 52 predicates, 0 of them its own earlier devices. 3 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 Biomet Trauma’s devices, and how often a recall has named them.

FDA decisions per year

3in 2009

2007: 22008: 22009: 3
2007high 3 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

1in 2019

2016: 12018: 12019: 1
2007high 1 (2016) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Biomet Trauma by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Biomet”

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