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

Titan Spine, LLC — Predicate Candidate Screening

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

111 daysmedian FDA review time

147 days90th percentile

14clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K173535	Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS	Titan Spine, LLC	2018-02-13	90	0
K170399	Endoskeleton TO Interbody Fusion Device (IBD)	Titan Spine, LLC	2017-07-06	147	0
K163269	Endoskeleton(R) TAS Interbody Fusion Device / Endoskeleton(R	Titan Spine, LLC	2017-04-13	143	0
K153122	Endoskeleton(r) TCS System	Titan Spine, LLC	2015-12-14	46	0
K151596	Endoskeleton TCS Interbody Fusion Device	Titan Spine, LLC	2015-10-09	119	0
K142940	Endoskeleton TCS System	Titan Spine, LLC	2015-01-28	111	2
K141953	ENDOSKELETON; TA IBD AND VBR, TO AND TT, TAS, TC, TL	Titan Spine, LLC	2014-10-27	101	0
K142589	Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoske	Titan Spine, LLC	2014-10-17	32	0
K140055	ENDOSKELETON(R) TL INTERBODY FUSION DEVICE	Titan Spine, LLC	2014-07-02	173	0
K111626	ENDOSKELETON(R) TAS	Titan Spine, LLC	2011-09-09	91	0
K102067	ENDOSKELETON TO	Titan Spine, LLC	2010-11-05	105	0
K100889	ENDOSKELETON TC	Titan Spine, LLC	2010-07-29	120	0
K083714	ENDOSKELETON TT INTERBODY FUSION DEVICE (IBD)	Titan Spine, LLC	2009-04-15	121	0
K080615	ENDOSKELETON TA INTERBODY FUSION DEVICE (IBD)	Titan Spine, LLC	2008-06-17	105	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