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

Zimmer Spine, Inc. — Predicate Candidate Screening

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

88 daysmedian FDA review time

180 days90th percentile

38clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K153631	Zimmer Virage OCT Spinal Fixation System	Zimmer Spine, Inc.	2016-02-16	60	0
K150896	Vitality Spinal Fixation System	Zimmer Spine, Inc.	2015-08-31	151	3
K151031	Virage OCT Spinal Fixation System	Zimmer Spine, Inc.	2015-06-24	68	0
K142752	Minit Posterior Cervical-Thoracic Fixation System, Nex-Link	Zimmer Spine, Inc.	2015-06-18	267	0
K143626	inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dy	Zimmer Spine, Inc.	2015-03-20	88	0
K143297	Ardis Interbody System, BAK Interbody Fusion System, BAK/C A	Zimmer Spine, Inc.	2015-02-12	87	0
K142053	UNIVERSAL CLAMP SPINAL FIXATION SYSTEM	Zimmer Spine, Inc.	2014-10-29	92	0
K141500	OPTIO-C ANTERIOR CERVICAL SYSTEM	Zimmer Spine, Inc.	2014-09-23	109	0
K133556	VIRAGE OCT SPINAL FIXATION SYSTEM	Zimmer Spine, Inc.	2014-06-02	195	0
K140611	TRINICA ANTERIOR LUMBAR PLATE SYSTEM	Zimmer Spine, Inc.	2014-05-21	72	0
K133184	ARDIS INTERBODY SYSTEM	Zimmer Spine, Inc.	2014-01-30	105	0
K133164	DYNESYS TOP-LOADING SPINAL SYSTEM	Zimmer Spine, Inc.	2014-01-16	91	0
K132894	OPTIO-C ANTERIOR CERVICAL SYSTEM	Zimmer Spine, Inc.	2014-01-16	122	0
K132790	INFIX ANTERIOR LUMBAR SYSTEM	Zimmer Spine, Inc.	2013-12-20	105	0
K133291	ST360 DEGREES SPINAL FIXATION SYSTEM	Zimmer Spine, Inc.	2013-12-17	53	0
K133086	TITLE 2 POLYAXIAL SPINAL SYSTEM	Zimmer Spine, Inc.	2013-11-27	58	0
K132884	PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM	Zimmer Spine, Inc.	2013-11-25	73	0
K131980	SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVER	Zimmer Spine, Inc.	2013-09-04	68	0
K131242	ARDIS INTERBODY SYSTEM	Zimmer Spine, Inc.	2013-09-03	125	0
K132012	TRINICA(R) ANTERIOR CERVICAL PLATE SYSTEM, TRINICA(R) SELECT	Zimmer Spine, Inc.	2013-08-29	59	0
K122733	V2F ANTERIOR FIXATION SYSTEM	Zimmer Spine, Inc.	2012-12-07	92	0
K121671	PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM	Zimmer Spine, Inc.	2012-07-18	42	0
K111119	TRABECULAR METAL (TM) FUSION DEVICE	Zimmer Spine, Inc.	2011-11-23	216	0
K111796	INVIZIA ANTERIOR CERVICAL PLATE SYSTEM	Zimmer Spine, Inc.	2011-10-27	122	0
K100845	PATHFINDER II, MINIMALLY INVASIE PEDICLE SCREW SYSTEM MODEL	Zimmer Spine, Inc.	2010-09-21	180	5
K101704	ZIMMER DTO PIN PRESS INSTRUMENT	Zimmer Spine, Inc.	2010-08-18	62	0
K092234	DYNESYS TOP-LOADING SPINAL SYSTEM	Zimmer Spine, Inc.	2009-10-01	70	0
K091190	UNIVERSAL CLAMP STAINLESS STEEL SYSTEM, MODELS SNA027-0-3006	Zimmer Spine, Inc.	2009-07-30	98	0
K080367	ZIMMER MIS LIGHT	Zimmer Spine, Inc.	2008-02-22	10	0
K073347	DYNESYS TOP-LOADING SPINAL SYSTEM	Zimmer Spine, Inc.	2008-02-08	71	2
K071879	ZIMMER DTO IMPLANT	Zimmer Spine, Inc.	2007-10-05	88	1
K071880	Optima ZS Transition Screw	Zimmer Spine, Inc.	2007-10-05	88	0
K072183	ST360 SPINAL FIXATION SYSTEM, MODEL 07.0029-7500.5600	Zimmer Spine, Inc.	2007-09-05	30	0
K061353	TRINICA ANTERIOR LUMBAR PLATE SYSTEM	Zimmer Spine, Inc.	2006-08-30	107	1
K060638	DYNESYS SPINAL SYSTEM WITH HA COATED SCREWS	Zimmer Spine, Inc.	2006-04-06	27	1
K043565	MODIFICATION TO DYNESYS SPINAL SYSTEM	Zimmer Spine, Inc.	2005-03-11	74	1
K042702	SILHOUETTE SPINAL FIXATION SYSTEM	Zimmer Spine, Inc.	2004-11-23	54	0
K041925	ST360 SPINAL FIXATION SYSTEM	Zimmer Spine, Inc.	2004-09-24	67	1

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