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

Spineart — Predicate Candidate Screening

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

76 daysmedian FDA review time

214 days90th percentile

44clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K230774	PERLA® TL System; TEKTONA® HV US Bone Cement	Spineart	2023-06-23	94	0
K213470	PERLA® TL Posterior Osteosynthesis System	Spineart	2022-01-21	85	0
K210472	SPINEART Navigation Instrument System	Spineart	2021-03-19	30	0
K203506	PERLA® TL posterior osteosynthesis system	Spineart	2021-01-15	46	2
K203222	PERLA TL Posterior Osteosynthesis System	Spineart	2020-12-17	45	0
K200571	PERLA® Posterior Occipito-Cervico-Thoracic Fixation System	Spineart	2020-05-01	58	0
K200312	Tryptik Ti	Spineart	2020-04-06	60	0
K193396	PERLA® TL posterior osteosynthesis system	Spineart	2020-02-05	61	1
K192993	SCARLET AL-T	Spineart	2020-01-22	89	0
K190877	Juliet® Ti LL Lumbar Interbody Device	Spineart	2019-05-29	55	1
K190322	SCARLET® AC-T Secured Anterior Cervical Cage	Spineart	2019-03-04	19	0
K190071	Perla® Posterior Cervico-Thoracic Fixation System	Spineart	2019-02-25	41	0
K181818	Scarlet AL-T	Spineart	2018-10-09	92	0
K181203	Juliet Ti	Spineart	2018-06-28	52	0
K171797	TRYPTIK2 C-Plate Anterior Cervical Plate System	Spineart	2018-02-26	255	0
K173702	Juliet Ti LL	Spineart	2018-01-03	30	0
K172065	SCARLET AC-T	Spineart	2017-09-29	84	0
K172101	ROMEO® 2 Posterior Osteosynthesis System	Spineart	2017-09-26	76	0
K161888	JULIET® LL Lateral Lumbar Cage	Spineart	2016-09-12	63	0
K153621	Juliet® Ti	Spineart	2016-07-15	210	1
K153042	TRYPTIK2C-plate Anterior Cervical Plate System	Spineart	2016-03-28	161	0
K153386	Perla Posterior Cervico-Thoracic Fixation system	Spineart	2016-01-25	63	0
K151104	OTELO LL	Spineart	2016-01-06	257	0
K151695	Romeo posterior osteosynthesis system	Spineart	2015-09-10	79	0
K143214	SCARLET® AC-T Secured Anterior Cervical Cage	Spineart	2015-02-23	105	0
K141135	JULIET LL	Spineart	2014-12-01	214	0
K142277	JULIET PO	Spineart	2014-10-14	60	0
K141314	SCARLET AC-T SECURED ANTERIOR CERVICAL CAGE AND ASSOCIATED I	Spineart	2014-09-29	132	0
K141835	ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM PREBENT CROSS-CONNECTO	Spineart	2014-09-10	65	0
K141508	ROMEO 2 PAD POSTERIOR AXIAL DEVICE	Spineart	2014-08-21	76	0
K140948	ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM	Spineart	2014-05-20	36	0
K140474	JULIET OL	Spineart	2014-04-18	52	0
K133557	JULIET LL LATERAL LUMBAR CAGE	Spineart	2014-02-03	76	0
K130267	ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM	Spineart	2013-05-31	116	0
K122366	TRYPTIK CC ANTERIOR INTERSOMATIC CERVICAL CAGE	Spineart	2012-10-04	59	0
K112108	ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM	Spineart	2011-08-19	28	0
K111127	ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM	Spineart	2011-08-11	112	0
K101678	ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM	Spineart	2010-07-28	43	0
K101720	JULIET OL	Spineart	2010-07-16	28	0
K093936	ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM	Spineart	2010-03-11	79	0
K093170	ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM	Spineart	2009-11-04	28	0
K091873	TRYPTIK CA ANTERIOR INTERSOMATIC CERVICAL CAGE, MODELS MOS-C	Spineart	2009-09-18	87	0
K081888	DYNAMIK INTERVERTEBRAL BODY FUSION DEVICE	Spineart	2009-02-06	219	0
K081165	ELLIPSE LUMBAR POSTERIOR OSTEOSYNTHESIS SYSTEM	Spineart	2008-12-17	237	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