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

Biomet Orthopedics, Inc. · Predicate Candidate Screening

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

55 daysmedian FDA review time

178 days90th percentile

34clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K080528	E-POLY TIBIAL BEARINGS	Biomet Orthopedics, Inc.	2008-06-17	112	0
K072879	INNERVUE DIAGNOSTIC SCOPE SYSTEM	Biomet Orthopedics, Inc.	2008-01-14	97	2
K070955	ACID ETCHED LAG SCREWS	Biomet Orthopedics, Inc.	2007-10-12	190	0
K033355	LACTOSCREW SCREW ANCHOR	Biomet Orthopedics, Inc.	2004-06-30	254	0
K032286	CALCIGEN PSI BONE GRAFT SUBSTITUTE	Biomet Orthopedics, Inc.	2003-11-20	119	0
K030048	HA PMI FEMORAL HIP STEM	Biomet Orthopedics, Inc.	2003-02-05	30	0
K024086	PROPELLER HEAD SMALL CANNULATED SCREW SYSTEM	Biomet Orthopedics, Inc.	2003-01-09	29	0
K023063	COMPREHENSIVE HUMERAL FRACTURE SYSTEM	Biomet Orthopedics, Inc.	2002-12-13	88	1
K023188	PRESS-FIT HEAD RESURFACING DEVICE	Biomet Orthopedics, Inc.	2002-12-11	78	0
K023357	ARCPM 1050 RESIN-HIPS	Biomet Orthopedics, Inc.	2002-11-06	30	1
K021661	RINGLOC CONSTRAINED LINERS	Biomet Orthopedics, Inc.	2002-10-25	158	0
K023085	RX 90 FEMORAL STEM AND RX 90 LATERALIZED FEMORAL STEM	Biomet Orthopedics, Inc.	2002-10-17	30	0
K022515	BIOMET CALCANEAL PLATE	Biomet Orthopedics, Inc.	2002-09-17	49	0
K022463	HA MODULAR REACH PROXIMAL POROUS AND HA MODULAR REACH COLLAR	Biomet Orthopedics, Inc.	2002-08-16	21	0
K022586	ANTERIOR STABILIZED TIBIAL BEARINGS	Biomet Orthopedics, Inc.	2002-08-15	10	0
K021254	LACTOSORB MINI INTERFERENCE SCREW	Biomet Orthopedics, Inc.	2002-07-17	89	0
K021799	CEMENTED FEMORAL HEAD RESURFING DEVICE	Biomet Orthopedics, Inc.	2002-06-26	26	0
K013790	CALCIGEN-S BONE VOID FILER	Biomet Orthopedics, Inc.	2002-06-11	209	0
K021403	HA MALLORY/HEAD POROUS FEMORAL STEM & HA MALLORY/HEAD POROUS	Biomet Orthopedics, Inc.	2002-05-31	29	0
K020381	EXPANDABLE KNEE	Biomet Orthopedics, Inc.	2002-05-06	90	0
K020963	TAPERLOC POROUS FEMORAL STEM & HA TAPERLOC POROUS LATERALIZE	Biomet Orthopedics, Inc.	2002-04-16	22	0
K020905	NBX - NON-BRIDGING EXTERNAL FIXATOR	Biomet Orthopedics, Inc.	2002-04-15	26	0
K020221	IQL BASIC FRAGMENT PLATE SET, IQL BASIC FRAGMENT SCREW SET,	Biomet Orthopedics, Inc.	2002-04-02	70	0
K013923	TITANIUM RETROGRADE FEMORAL NAIL - 13 MM DIAMETER	Biomet Orthopedics, Inc.	2002-02-25	90	0
K020264	REPICCI II UNICONDYLAR KNEE SYSTEM	Biomet Orthopedics, Inc.	2002-02-08	14	0
K020076	PATRIOT PROTRUSIO CAGE	Biomet Orthopedics, Inc.	2002-01-30	21	0
K020045	3-PIECE PROXIMAL HUMERAL REPLACEMENT SYSTEM	Biomet Orthopedics, Inc.	2002-01-30	23	0
K013534	SELF-COUNTERSINKING BONE SCREW	Biomet Orthopedics, Inc.	2001-12-17	55	0
K013657	MODIFICATION TO: BIOMET HUMERAL CABLE PLATES	Biomet Orthopedics, Inc.	2001-12-03	27	0
K013042	DISCOVERY ELBOW	Biomet Orthopedics, Inc.	2001-10-10	30	3
K010827	COPELAND MB/HA RESURFACING HUMERAL HEADS	Biomet Orthopedics, Inc.	2001-09-14	178	0
K002278	BROOKER FEMORAL NAILS	Biomet Orthopedics, Inc.	2000-10-23	89	0
K002057	BROOKER TIBIA NAILS	Biomet Orthopedics, Inc.	2000-10-04	90	0
K001660	MALLORY HEAD MODULAR CALCAR	Biomet Orthopedics, Inc.	2000-06-14	14	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