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

OWI — Predicate Candidate Screening

37 FDA 510(k) clearances under this product code; the 50 most recent screened below.

89 daysmedian FDA review time

189 days90th percentile

37clearances measured

K-number	Device	Applicant	Decided	Review days
K261374	LigaPASS™ System	Medicrea International S.A.S	2026-05-27	30
K253615	Invictus Bands System	Alphatec Spine, Inc.	2026-03-25	127
K222097	OLYMPIC Deformity Band System	Astura Medical	2023-05-04	290
K230565	HILINE™ Fixation System	Globus Medical, Inc.	2023-04-20	50
K213659	LigaPASS™ 2.0 Ligament Augmentation System	Medicrea International SA	2022-05-24	186
K211057	LigaPASS® Spinal System, CD Horizon™ Spinal System	Medtronic, Inc.	2021-05-27	48
K201240	Mariner Cap System	SeaSpine Orthopedics Corporation	2020-08-05	89
K200281	The Gecko Spinal System	Ortho Development Corporation	2020-03-31	56
K200097	Response BandLoc Spinal Fixation	OrthoPediatrics Corp.	2020-03-16	60
K191217	JAZZ PF	Implanet, S.A.	2019-08-02	88
K190289	Karma® Fixation System	Spinal Elements, Inc.	2019-04-03	51
K190418	NuVasive® VersaTie® System	Nu Vasive, Incorporated	2019-03-21	28
K180728	Spinal Elements Cerclage System	Spinal Elements, Inc.	2018-09-06	170
K181799	ResCUBE™ Ligament Fixation System	Cousin Biotech Sas	2018-08-29	55
K172206	NAJA™ Ligament Correction System	Cousin Biotech Sas	2018-04-10	263
K173506	LigaPASS	Medicrea International SA	2018-04-03	141
K173117	NuVasive® VersaTie™ System	Nuvasive, Inc.	2017-12-07	69
K172417	SILC® Fixation System	Globus Medical, Inc.	2017-10-26	77
K172021	LigaPASS	Medicrea International SA	2017-08-30	56
K171881	JAZZ Passer Band	Implanet, S.A.	2017-08-08	46
K170730	JAZZ System, including JAZZ Band	Implanet, S.A.	2017-06-09	92
K163181	TRANSLACE™ Spinal Tethering System	Medtronic Sofamor Danek USA, Inc.	2017-05-16	183
K161332	NILE Proximal Fixation Spinal System	K2m, Inc.	2017-04-05	328
K160698	LigaPASS	Medicrea International SA	2016-09-02	172
K161267	Response BandLoc Spinal Fixation	OrthoPediatrics Corp.	2016-08-11	98
K161265	NuVasive® VersaTie System	Nu Vasive, Incorporated	2016-07-15	71
K153348	JAZZ LOCK	Implanet, S.A.	2016-03-31	132
K160208	NILE Alternative Fixation Spinal System	K2m, Inc.	2016-03-18	50
K151740	JAZZ System	Implanet, S.A.	2015-08-27	62
K143759	JAZZ System	Implanet, S.A.	2015-05-07	127
K143350	Nile Alternative Fixation	K2m, Inc.	2015-02-25	93
K142053	UNIVERSAL CLAMP SPINAL FIXATION SYSTEM	Zimmer Spine, Inc.	2014-10-29	92
K133482	SILC FIXATION SYSTEM	Globus Medical, Inc.	2014-05-21	189
K133617	JAZZ SYSTEM	Implanet, S.A.	2014-02-20	87
K132395	LIGAPASS	Medicrea International	2013-12-06	127
K132287	JAZZ SYSTEM	Hogan Lovells US LLP	2013-09-25	64
K110348	UNIVERSAL CLAMP SPINAL FIXATION SYSTEM	Zimmer Spine	2011-08-11	185

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