Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Biomet Trauma · Predicate Candidate Screening

7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

57 daysmedian FDA review time

129 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K091976	BIOMET PHOENIX ANKLE NAIL AND ANKLE ARTHRODESIS NAIL	Biomet Trauma	2009-08-17	47	2
K092078	OPTILOCK PERIARTICULAR PLATING	Biomet Trauma	2009-08-05	27	0
K082874	BIODRIVE CANNULATED SCREW SYSTEM	Biomet Trauma	2009-02-05	129	0
K081244	LOWER EXTREMITY EXTERNAL FIXATION - EXPANDED INDICATIONS	Biomet Trauma	2008-07-30	90	0
K081243	BIOMET PHOENIX ANKLE NAIL SYSTEM	Biomet Trauma	2008-06-27	57	0
K071325	BIOMET VARIABLE LOCKING PLATE SYSTEM	Biomet Trauma	2007-07-26	77	0
K070823	GROWTH CONTROL PLATING SYSTEM	Biomet Trauma	2007-05-07	42	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda