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

Biomet, Inc. — Predicate Candidate Screening

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

85 daysmedian FDA review time

265 days90th percentile

442clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K253434	OSSTM Orthopedic Salvage System	Biomet, Inc.	2026-07-01	273	0
K251270	Taperloc® Complete Hip Stem	Biomet, Inc.	2026-05-19	390	0
K241014	Biomet Kirschner Wires (K-Wires)	Biomet, Inc.	2024-05-22	40	0
K222760	StageOne™ Select Hip Cement Spacer Molds	Biomet, Inc.	2022-12-28	106	0
K221968	StageOne™ Shoulder Cement Spacer Molds	Biomet, Inc.	2022-09-15	72	0
K213287	StageOne Knee Cement Spacer Molds	Biomet, Inc.	2022-09-02	336	0
K212431	Biomet Answer/Impact/Integral Distal Centralizer/Centering S	Biomet, Inc.	2022-02-07	187	0
K212435	Comprehensive Humeral Fracture Positioning Sleeves	Biomet, Inc.	2021-12-10	128	0
K210192	A.L.P.S. Clavicle Plating System	Biomet, Inc.	2021-02-19	25	0
K193214	WasherLoc and No-Profile Screw and Washer Systems, Biomet Ca	Biomet, Inc.	2020-11-10	355	0
K193546	Distal Centralizers	Biomet, Inc.	2020-09-25	280	0
K193373	Comprehensive® Reverse Shoulder	Biomet, Inc.	2020-04-15	132	1
K193402	ALLthread PEEK Suture Anchor	Biomet, Inc.	2020-03-05	90	0
K193451	Titanium Interference Screws	Biomet, Inc.	2020-02-24	73	0
K193533	WIN Flexible Nail System	Biomet, Inc.	2020-02-20	62	0
K192942	ALLthread Titanium Suture Anchor	Biomet, Inc.	2020-01-16	90	0
K193092	TunneLoc Tibial Fixation Device	Biomet, Inc.	2020-01-02	57	0
K191459	JuggerStitch Meniscal Repair Device	Biomet, Inc.	2019-09-13	102	0
K190035	Biomet Headless Compression and Twist-Off Screws	Biomet, Inc.	2019-02-07	30	0
K183553	Compress and Mini Compress Anti-Rotation Spindles	Biomet, Inc.	2019-01-22	33	0
K183162	Affixus Hip Fracture Nail	Biomet, Inc.	2018-12-14	29	0
K173767	A. L. P. S. Clavicle Plating System	Biomet, Inc.	2018-04-06	116	1
K173826	THP Hip Fracture Plating System	Biomet, Inc.	2018-02-07	51	0
K173278	ToggleLoc System	Biomet, Inc.	2018-01-05	84	0
K172408	Biomet Bone Cement R	Biomet, Inc.	2017-10-05	57	0
K171540	Refobacin Bone Cement R	Biomet, Inc.	2017-08-30	96	0
K171054	Biomet Knee Joint Replacement Prostheses	Biomet, Inc.	2017-07-28	109	3
K162559	Move Forward 3D Motion Simulation Service	Biomet, Inc.	2017-03-31	198	0
K161273	StageOne Disposable Cement Spacer Molds for Temporary Knee P	Biomet, Inc.	2017-01-25	265	8
K161592	Persona Partial Knee System	Biomet, Inc.	2016-11-03	147	0
K162424	Ulna Plating System	Biomet, Inc.	2016-10-12	43	0
K161166	StageOne Select Cement Spacer Molds for Temporary Hip Replac	Biomet, Inc.	2016-09-08	135	15
K160071	StageOne Disposable Cement Spacer Molds for Temporary Hemi-S	Biomet, Inc.	2016-06-16	155	5
K161190	G7 Dual Mobility System, Active Articulation System	Biomet, Inc.	2016-05-26	29	0
K153657	Vanguard XP Knee System	Biomet, Inc.	2016-05-10	141	0
K160058	Biomet Variable Pitch Compression Screw System	Biomet, Inc.	2016-03-09	57	0
K152621	OSS/Arcos IM Total Femur Rod	Biomet, Inc.	2015-10-14	30	0
K151603	Arcos One-piece Femoral Revision System	Biomet, Inc.	2015-10-06	116	0
K150850	Refobacin Bone Cement R	Biomet, Inc.	2015-07-16	107	0
K150867	Affixus Tibial Nailing System	Biomet, Inc.	2015-06-10	70	0
K150522	G7 Dual Mobility System	Biomet, Inc.	2015-05-01	60	1
K150503	Echo Bi-Metric Microplasty Line Extension	Biomet, Inc.	2015-03-25	27	0
K143192	Vanguard 360 Revision Knee System	Biomet, Inc.	2015-02-12	98	0
K142882	G7 Freedom and Offset Liners, Freedom Head, Size 32	Biomet, Inc.	2015-02-10	131	0
K143543	Prelude PF Patellae	Biomet, Inc.	2015-01-30	46	1
K142933	Biomet Tibial trays	Biomet, Inc.	2014-12-23	75	2
K143009	Echo Bi-Metric Microplasty Hip System	Biomet, Inc.	2014-12-18	59	0
K140669	G7 OSSEOTI ACETUBLAR SHELLS	Biomet, Inc.	2014-12-11	268	0
K141407	VANGUARD XP FEMORAL COMPONENT(GEN II)/VANGUARD XP FEMORAL TR	Biomet, Inc.	2014-10-27	152	1
K141331	BIOMET ORTHOPAEDIC SALVAGE SYSTEM (OSS)	Biomet, Inc.	2014-10-27	159	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