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

Stryker Spine — Predicate Candidate Screening

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

72 daysmedian FDA review time

195 days90th percentile

75clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K262061	Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tri	Stryker Spine	2026-07-17	29	0
K261008	Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip;	Stryker Spine	2026-04-24	29	0
K242361	OZARK Cervical Plate System; PYRENEES® Cervical Plate System	Stryker Spine	2024-11-07	90	0
K242280	Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip,	Stryker Spine	2024-08-29	27	0
K222684	XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3	Stryker Spine	2023-06-08	275	0
K221490	Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Trita	Stryker Spine	2023-02-14	267	0
K203205	Navigated Spine Instruments	Stryker Spine	2021-03-23	144	0
K200666	Stryker Xia 3 Power Adaptor	Stryker Spine	2020-04-23	41	0
K183249	Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X	Stryker Spine	2019-07-25	246	0
K183071	VLIFT-s Vertebral Body Replacement System	Stryker Spine	2019-01-10	66	0
K181014	Tritanium PL Cage	Stryker Spine	2018-07-18	92	0
K171496	Tritanium C Anterior Cervical Cage	Stryker Spine	2017-09-06	107	0
K161407	Ascential IBD PEEKc Spacer	Stryker Spine	2016-07-15	56	0
K152532	AERO -C Cervical Cage System	Stryker Spine	2015-12-18	106	0
K133188	MANTIS & MANTIS REDUX SPINAL SYSTEM, RADIUS SPINAL SYSTEM, T	Stryker Spine	2013-12-17	61	0
K132968	UNIVISE SPINOUS PROCESS FIXATION PLATE (35MM, 40MM)	Stryker Spine	2013-11-18	56	0
K122845	ES2 SPINAL SYSTEM MODEL 48280XXXX	Stryker Spine	2012-12-07	81	0
K122637	LITE DECOMPRESSION SYSTEM- LIGHT CABLE MODEL 48089999	Stryker Spine	2012-11-01	64	0
K120869	ANCHOR-L LUMBAR CAGE	Stryker Spine	2012-10-25	217	0
K113666	XIA 3 SPINAL SYSTEM	Stryker Spine	2012-08-28	259	0
K120486	AVS AS PEEK SPACER	Stryker Spine	2012-08-20	185	0
K113802	ESCALATE LAMINOPLASTY SYSTEM	Stryker Spine	2012-04-16	115	0
K111719	OASYS SPINAL SYSTEM	Stryker Spine	2012-01-19	213	0
K110419	AVS ARIA NEUROMONITORING PROBE AND AVS ARIA PROBE DILATORS	Stryker Spine	2011-07-28	164	0
K102606	AVS ANCHOR-C CERVICAL CAGE SYSTEM	Stryker Spine	2011-04-22	224	1
K101183	MODIFICATION TO: OASYS SYSTEM	Stryker Spine	2010-11-09	195	0
K102235	MANTIS SPINAL SYSTEM & MANTIS REDUX SPINAL SYSTEM	Stryker Spine	2010-08-24	15	0
K101051	AVS A-LAT PEEK SPACERS, MODELS 48750XXX, 48751XXX, 48752XXX,	Stryker Spine	2010-08-12	119	0
K100865	AVA NAVIGATOR PEEK SPACERS, MODEL 48392XXX, 48393XXX	Stryker Spine	2010-08-11	135	0
K101144	MODIFICATION TO:RADIUS SPINAL SYSTEM	Stryker Spine	2010-07-08	76	0
K100737	MODIFICATION TO: TRIO+SPINAL FIXATION SYSTEM	Stryker Spine	2010-04-12	28	0
K093670	MODIFICATION TO: OASYS SYSTEM	Stryker Spine	2010-03-18	111	1
K092605	XIA 4.5 SPINAL SYSTEM	Stryker Spine	2009-12-03	101	0
K092631	MANTIS REDUX SPINAL SYSTEM	Stryker Spine	2009-09-25	30	0
K091946	VLIFT-S VERTEBRAL BODY REPLACEMENT SYSTEM, MODELS 488812XX,	Stryker Spine	2009-09-25	87	0
K091291	XIA 3 SPINAL SYSTEM, UNIPLANNER/REDUCTION SCREWS & VITALLIUM	Stryker Spine	2009-06-24	54	0
K083393	XIA 3 SPINAL SYSTEM	Stryker Spine	2009-04-01	135	1
K082608	RADIUS SPINAL SYSTEM, VITALLIUM ROD #486613601	Stryker Spine	2008-10-07	29	0
K080773	THOR ANTERIOR PLATING SYSTEM	Stryker Spine	2008-06-09	82	0
K080928	XIA SPINAL SYSTEM, STAINLESS STEEL UNI-PLANAR SCREWS	Stryker Spine	2008-04-30	28	0
K073470	AVS PL PEEK SPACERS, MODELS 48351XXX AND 48353XXX	Stryker Spine	2008-03-06	87	0
K080143	MODIFICATION TO STRYKER SPINE OASYS SYSTEM	Stryker Spine	2008-02-14	23	0
K073437	THOR ANTERIOR PLATING SYSTEM	Stryker Spine	2008-02-13	69	31
K072568	MODIFICATION TO OASYS SYSTEM	Stryker Spine	2007-10-05	23	0
K071373	STRYKER SPINE XIA III SPINAL SYSTEM	Stryker Spine	2007-08-27	103	1
K070631	DEVICE MODIFICATION TO RADIUS SPINAL SYSTEM	Stryker Spine	2007-07-13	128	0
K063430	ZERO PROFILE ANTERIOR CERVICAL PLATE (ACP) SYSTEM	Stryker Spine	2007-03-22	129	0
K063428	XIA STAINLESS STEEL SPINAL SYSTEM	Stryker Spine	2006-12-11	28	0
K062270	RADIUS SPINAL SYSTEM	Stryker Spine	2006-11-22	107	1
K062853	MODIFICATION TO STRYKER SPINE OASYS SYSTEM	Stryker Spine	2006-10-24	29	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