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

Medicrea International SA · Predicate Candidate Screening

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

149 daysmedian FDA review time

266 days90th percentile

25clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K213659	LigaPASS™ 2.0 Ligament Augmentation System	Medicrea International SA	2022-05-24	186	0
K213281	PASS LP™ Spinal System, CD Horizon™ Spinal System	Medicrea International SA	2022-01-05	96	0
K210470	C-CURVE Interbody Fusion Device	Medicrea International SA	2021-09-03	198	0
K200316	UNiD IB3D ALIF	Medicrea International SA	2020-10-30	266	0
K191134	IB3D ALIF	Medicrea International SA	2019-10-30	184	0
K182158	UNiD Patient-matched PLIF cage	Medicrea International SA	2019-07-15	340	0
K190092	UNiD Patient specific 3D printed TLIF cage	Medicrea International SA	2019-05-08	110	0
K190376	PASS LP Spinal System	Medicrea International SA	2019-05-02	72	0
K182240	PASS LP Spinal System	Medicrea International SA	2018-10-17	58	0
K173782	UNiD Patient Specific 3D printed cage	Medicrea International SA	2018-04-25	133	0
K173506	LigaPASS	Medicrea International SA	2018-04-03	141	0
K163595	IMPIX 3D Print Cages	Medicrea International SA	2017-11-13	327	1
K172021	LigaPASS	Medicrea International SA	2017-08-30	56	0
K162786	PASS LP Spinal System	Medicrea International SA	2017-01-25	114	0
K162194	MEDICREA INTERNATIONAL Anterior Cervical Locking Plate Syste	Medicrea International SA	2016-12-08	125	0
K160640	PASS XS Spinal System	Medicrea International SA	2016-09-23	200	0
K160698	LigaPASS	Medicrea International SA	2016-09-02	172	0
K161627	PASS LP Spinal System	Medicrea International SA	2016-07-29	46	0
K161149	PASS OCT Spinal System	Medicrea International SA	2016-07-11	77	0
K160756	PASS OCT Spinal System	Medicrea International SA	2016-04-26	39	0
K153413	PASS LP Spinal System	Medicrea International SA	2016-04-22	149	0
K150918	PASS OCT Spinal System	Medicrea International SA	2015-10-16	193	0
K142798	PASS LP Spinal System	Medicrea International SA	2015-03-25	177	0
K141187	IMPIX ALIF S/A	Medicrea International SA	2015-01-15	252	1
K141398	PASS LP SPINAL SYSTEM	Medicrea International SA	2015-01-09	226	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