Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

JXI — Predicate Candidate Screening

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

117 daysmedian FDA review time

416 days90th percentile

40clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K260245	SILKBridge	KLISBio S.r.l.	2026-04-09	72	0
K253363	NeuroSpan Bridge	Auxilium Biotechnologies, Inc.	2026-01-17	109	0
K251505	VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protec	Alafair Biosciences	2025-07-22	67	0
K251175	VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protec	Alafair Biosciences	2025-07-17	92	0
K243889	Remplir (ON-152, 15 x 20 mm); Remplir (ON-203, 20 x 30 mm);	Orthocell, Ltd.	2025-04-02	105	0
K242113	Nerve Wrap (07-DW-001-TAB)	Biocircuit Technologies, Inc.	2025-04-02	257	0
K233322	Mochida Nerve Cuff	Mochida Pharmaceutical Co., Ltd.	2024-06-21	266	0
K233533	NerveTape	Biocircuit Technologies, Inc.	2024-02-12	102	0
K230794	Rebuilder Nerve Guidance Conduit	Celestray Biotech Company, LLC.,	2024-01-29	313	0
K232029	VersaWrap Nerve Protector	Alafair Biosciences, Inc.	2023-11-02	118	0
K231708	Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Pr	Axogen Corporation	2023-10-12	122	0
K223640	Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Pr	Axogen Corporation	2023-04-07	123	0
K210665	Nerve Tape	Biocircuit Technologies, Incorporated	2022-07-15	497	0
K202234	NervAlign Nerve Cuff	Renerve, Ltd.	2022-02-10	552	0
K201631	VersaWrap Nerve Protector	Alafair Biosciences, Inc.	2020-09-14	90	0
K190246	NeuroShield	Monarch Bioimplants GmbH	2019-05-31	114	0
K180222	Reaxon Plus	Medovent GmbH	2018-04-24	89	0
K163446	AxoGen Nerve Cap	Axogen Corporation	2017-08-08	243	0
K170656	Reinforced Flexible Collagen Nerve Cuff	Collagen Matrix, Inc.	2017-06-01	90	0
K163457	NeuraGen 3D Nerve Guide Matrix	Integra LifeSciences Corporation	2017-01-06	28	0
K162741	AxoGuard Nerve Connector	Cook Biotech Incorporated	2016-10-31	31	0
K152967	NERBRIDGE	Toyobo Co., Ltd.	2016-06-22	258	0
K152684	Nerve Capping Device	Polyganics Innovations BV	2016-01-13	117	0
K143711	Reaxon Plus	Medovent GmbH	2015-12-02	338	0
K130557	NEURAGEN 3D	Integra LifeSciences Corporation	2014-04-24	416	0
K131541	FLEXIBLE COOAGEN NERVE CUFF	Collagen Matrix, Inc.	2014-04-03	309	0
K132660	NERVE CUFF	Cook Biotech Incorporated	2014-01-10	137	0
K103081	COVAORTHO-NERVE RESORBABLE COLLAGEN MEMBRANE	Biom'Up Sas	2012-03-02	500	0
K112267	NEUROLAC(R) NERVE GUIDE	Polyganics B.V.,	2011-10-20	73	0
K100382	SALUTUNNEL NERVE PROTECTOR, MODEL ED-20329, ED-20330, ED-203	Salumedica, LLC	2010-08-05	170	0
K060952	COLLAGEN NERVE WRAP	Collagen Matrix, Inc.	2006-07-14	99	0
K050573	NEUROLAC NERVE GUIDE	Polyganics B.V.,	2005-05-04	58	0
K041620	NEURA WRAP NERVE PROTECTOR	Integra Lifesciences Corp.	2004-07-16	30	1
K032115	NEUROLAC NERVE GUIDE MODELS NG01-15/03, NG01-020/03, NG01 02	Polyganics B.V.,	2003-10-10	93	0
K031069	SURGISIS NERVE CUFF	Cook Biotech, Inc.	2003-05-15	41	0
K012814	COLLAGEN NERVE CUFF	Collagen Matrix, Inc.	2001-09-21	30	0
K011168	NEUROGEN NERVE GUIDE	Integra Lifesciences Corp.	2001-06-22	66	1
K002098	SALUMEDICA NERVE CUFF	Salumedica, LLC	2000-11-24	136	0
K983007	NEUROTUBE	Neuroregen, LLC	1999-03-22	206	1
K850785	FASTUBE NERVE REGENERATION DEVICE	Research Medical, Inc.	1985-07-10	134	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