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

Zimmer, Inc. — Predicate Candidate Screening

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

87 daysmedian FDA review time

229 days90th percentile

376clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K260831	Z1 Hip System	Zimmer, Inc.	2026-06-16	95	0
K261683	Augment Off-Axis Instrument System	Zimmer, Inc.	2026-06-16	26	0
K251840	Zimmer® Persona® Personalized Knee System	Zimmer, Inc.	2026-05-28	346	0
K260182	Avenir® Müller Stem; Avenir Complete™ Hip System	Zimmer, Inc.	2026-04-27	96	0
K253592	Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral	Zimmer, Inc.	2026-04-13	147	0
K253566	Affixus Retrograde Femoral Nailing System	Zimmer, Inc.	2026-03-12	115	0
K253189	Persona the Personalized Knee System (Persona Porous Plasma	Zimmer, Inc.	2026-03-09	164	0
K252623	G7® Revision Acetabular System	Zimmer, Inc.	2026-02-04	169	0
K251098	Identity Revision Humeral Stems	Zimmer, Inc.	2025-08-11	123	0
K251906	Z1 Hip System	Zimmer, Inc.	2025-07-18	28	0
K250848	Identity Shoulder System	Zimmer, Inc.	2025-07-02	104	0
K243724	Persona® Revision Knee System (Persona Revision SoluTion™ Fe	Zimmer, Inc.	2025-03-06	93	0
K243907	Affixus Tibial Nailing System - 4mm screws	Zimmer, Inc.	2025-02-12	55	0
K241873	OsseoFit Stemless Shoulder System	Zimmer, Inc.	2024-12-11	167	0
K242543	Persona the Personalized Knee System (Persona Ti-Nidium PPS	Zimmer, Inc.	2024-11-22	88	0
K243247	Persona the Personalized Knee System	Zimmer, Inc.	2024-10-29	18	0
K241651	Affixus Tibial and Antegrade Femoral Nailing System	Zimmer, Inc.	2024-09-26	111	17
K240876	Identity Shoulder System	Zimmer, Inc.	2024-06-12	75	0
K240299	Persona the Personalized Knee System (Persona OsseoTi 3-Peg	Zimmer, Inc.	2024-04-26	85	0
K230321	Persona™ Personalized Knee System	Zimmer, Inc.	2023-03-08	30	0
K221479	Persona Personalized Knee System	Zimmer, Inc.	2022-11-17	178	0
K222566	Zimmer Persona Personalized Knee System	Zimmer, Inc.	2022-10-17	54	0
K213856	Identity Shoulder System	Zimmer, Inc.	2022-09-15	279	0
K212512	G7® Vivacit-E® Freedom® Constrained Liner	Zimmer, Inc.	2022-04-28	261	0
K210842	VerSys Cemented Revision/Calcar	Zimmer, Inc.	2021-12-10	263	0
K210829	Persona Revision Knee System Femoral Metaphyseal Cones	Zimmer, Inc.	2021-05-18	60	0
K210551	Persona Revision Knee System	Zimmer, Inc.	2021-03-18	21	1
K192798	Zimmer Segmental System	Zimmer, Inc.	2020-12-10	437	0
K191449	ZCA All-Poly Acetabular Cups	Zimmer, Inc.	2020-07-16	412	0
K200823	Zimmer, Inc. Hip Joint Prostheses MR Labeling I	Zimmer, Inc.	2020-07-09	101	1
K200209	Persona Personalized Knee System	Zimmer, Inc.	2020-03-24	56	0
K191735	CPT Hip System	Zimmer, Inc.	2020-03-20	266	0
K200151	Persona Partial Knee Tibial Cut Guide 5 Deg Left Medial Righ	Zimmer, Inc.	2020-03-17	55	0
K192660	Zimmer M/L Taper Hip Prosthesis	Zimmer, Inc.	2020-02-28	156	0
K193180	Alliance Augmented Glenoid	Zimmer, Inc.	2020-02-24	98	0
K193223	Persona Personalized Knee System	Zimmer, Inc.	2020-01-24	63	0
K192189	Avenir Complete Hip System, Size 0 Coxa Vara	Zimmer, Inc.	2019-12-18	127	0
K190656	Dual Mobility - Longevity and Vivacit-E Polyethylene Hip Bea	Zimmer, Inc.	2019-12-06	267	2
K190660	G7 Acetabular System Longevity Highly Crosslinked Polyethyle	Zimmer, Inc.	2019-12-05	266	0
K183457	Zimmer Biomet 12/14 CoCr Femoral Head and Freedom Head	Zimmer, Inc.	2019-11-05	327	0
K191814	Alliance Glenoid	Zimmer, Inc.	2019-10-23	110	0
K191625	Persona Revision Knee System	Zimmer, Inc.	2019-09-05	79	1
K191238	Zimmer Guide Wire Devices	Zimmer, Inc.	2019-07-05	58	0
K190068	Vanguard XP Knee System	Zimmer, Inc.	2019-06-04	140	0
K182678	Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology MR	Zimmer, Inc.	2019-05-31	247	0
K183583	Vanguard Complete Knee System	Zimmer, Inc.	2019-05-10	140	0
K181171	Zimmer Biomet Ceramic Heads	Zimmer, Inc.	2019-04-02	335	5
K183136	Zimmer Segmental System Proximal Femoral Component	Zimmer, Inc.	2019-01-30	78	0
K181307	Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow	Zimmer, Inc.	2019-01-28	256	0
K181761	Zimmer Biomet Select Ceramic Heads	Zimmer, Inc.	2018-12-26	176	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