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

Genesys Spine — Predicate Candidate Screening

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

106 daysmedian FDA review time

306 days90th percentile

31clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K252322	SIros-X System	Genesys Spine	2025-10-22	89	0
K242483	Genesys Spine AIS-C II Cervical Interbody Fusion System	Genesys Spine	2025-02-07	170	0
K233595	Genesys Spine Sacroiliac Joint Fusion System with Navigation	Genesys Spine	2024-03-29	142	0
K233594	Genesys Spine 3DP AIS-C II Cervical Interbody System	Genesys Spine	2023-12-13	35	0
K220096	Genesys Spine 3DP Lumbar Interbody System	Genesys Spine	2022-03-09	56	0
K191489	Genesys Spine 3DP Cervical Interbody System	Genesys Spine	2020-01-08	218	0
K182987	Genesys Spine 3DP Lumbar Interbody System	Genesys Spine	2019-12-12	409	0
K192678	Genesys Spine Binary® Lumbar Plate System	Genesys Spine	2019-10-24	28	0
K191748	Genesys Spine Sacroiliac Joint Fusion System	Genesys Spine	2019-09-26	87	0
K192076	Binary® Anterior Cervical Plate System	Genesys Spine	2019-08-29	27	0
K181295	Genesys Spine AIS-C Cervical Stand-Alone System	Genesys Spine	2018-08-29	105	0
K173885	Genesys Spine Binary Lumbar Plate System	Genesys Spine	2018-04-03	103	0
K180056	Genesys Spine AIS-C Cervical Anchored Interbody System	Genesys Spine	2018-03-28	79	0
K172469	TiLock Modular Spinal System	Genesys Spine	2017-11-30	107	0
K171838	TiLock2 Spinal System	Genesys Spine	2017-07-19	29	0
K171656	Genesys Spine Apache Interbody Fusion System	Genesys Spine	2017-07-13	38	0
K161438	Genesys Spine Apache® Anterior Lumbar Interbody Fusion Syste	Genesys Spine	2016-11-08	168	0
K161914	Genesys Spine TiLock Cortical Spinal System	Genesys Spine	2016-08-09	28	0
K152099	Genesys Spine Apache® Anchored Cervical Interbody Fusion Sys	Genesys Spine	2016-07-28	366	0
K161404	Genesys Spine Apache® Lateral Lumbar Interbody Fusion System	Genesys Spine	2016-07-21	62	0
K153123	Genesys Spine Apache Interbody Fusion System	Genesys Spine	2016-04-26	180	0
K152039	Genesys Spine TiLock2 Spinal System	Genesys Spine	2015-10-28	98	0
K150812	Genesys Spine Apache Cervical Interbody Fusion System	Genesys Spine	2015-09-03	161	0
K133245	GENESYS SPINE ANTERIOR CERVICAL PLATE II SYSTEM	Genesys Spine	2014-10-08	351	0
K133911	GENESYS SPINE ANTERIOR BUTTRESS PLATE SYSTEM	Genesys Spine	2014-09-03	254	0
K130913	GENESYS SPINE APACHE LATERAL LUMBAR INTERBODY FUSION SYSTEM	Genesys Spine	2013-12-13	255	0
K130317	GENESYS SPINE APACHE IBFD STAR CERVICAL SYSTEM	Genesys Spine	2013-12-11	306	0
K111132	GENESYS SPINE ANTERIOR CERVICAL PLATE SYSTEM	Genesys Spine	2011-12-09	231	1
K103671	GENESYS SPINE TILOCK SYSTEM	Genesys Spine	2011-07-21	217	0
K103034	GENESYS SPINE INTERBODY FUSION SYSTEM	Genesys Spine	2010-12-10	58	1
K100757	TILOCK PEDICLE SCREW SYSTEM	Genesys Spine	2010-07-01	106	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