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

Inion , Ltd. — Predicate Candidate Screening

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

54 daysmedian FDA review time

250 days90th percentile

23clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K071810	INION SPINAL GRAFT CONTAINMENT SYSTEM	Inion , Ltd.	2008-07-11	375	0
K063410	INION CPS/OTPS FREEDOMPLATE	Inion , Ltd.	2007-01-23	71	0
K062617	MODIFICATION TO INION OTPS BIODEGRADABLE FIXATION SYSTEM	Inion , Ltd.	2006-10-04	29	0
K060393	INION HEXALON BIODEGRADABLE ACL/PCL SCREW	Inion , Ltd.	2006-03-13	26	0
K051821	INION S-1 BIODEGRADABLE ANTERIOR CERVICAL FUSION SYSTEM	Inion , Ltd.	2005-11-25	143	0
K052624	INION OTPS BIODEGRADABLE DISTAL RADIUS PLATE	Inion , Ltd.	2005-11-16	54	0
K052444	INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM	Inion , Ltd.	2005-09-20	14	0
K051341	INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM, 40 AND 64	Inion , Ltd.	2005-05-27	4	0
K050275	MODIFICATION TO: INION OTPS BIODEGRADABLE PIN	Inion , Ltd.	2005-03-07	28	0
K043142	INION OTPS BIODEGRADABLE MINI PLATING SYSTEM	Inion , Ltd.	2005-02-18	95	0
K031714	INION TRINION BIODEGRADABLE MENISCUS SCREW	Inion , Ltd.	2004-08-16	441	0
K033074	INION GTR BIODEGRADABLE MEMBRANE SYSTEM	Inion , Ltd.	2004-03-31	184	0
K031961	INION OTPS BIODEGRADABLE MESH PLATING SYSTEM	Inion , Ltd.	2004-03-01	250	0
K033194	INION CPS BABY 1.5 BIOABSORBABLE SYSTEM	Inion , Ltd.	2003-10-30	28	0
K031712	INION OTPS BIODEGRADABLE PIN	Inion , Ltd.	2003-08-28	87	0
K030900	INION OTPS BIODEGRADABLE FIXATON SYSTEM	Inion , Ltd.	2003-06-19	87	0
K023887	INION OTPS BIODEGRADABLE MINI PLATING SYSTEM	Inion , Ltd.	2003-05-30	190	0
K022981	INION CPS 2.5/2.8 SCREW	Inion , Ltd.	2002-09-12	3	0
K021280	INION HEXALON BIODEGRADABLE ACL/PCL SCREW	Inion , Ltd.	2002-07-17	86	0
K020266	INION CPS BSSO SCREW	Inion , Ltd.	2002-02-22	28	3
K013039	INION CPS 2.0 ORTHOGNATHIC PLATE	Inion , Ltd.	2001-10-05	25	0
K010351	INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM	Inion , Ltd.	2001-03-15	37	2
K010352	CPS 1.5/2.0/2.5 BIOABSORBABLE FIXATION SYSTEM	Inion , Ltd.	2001-03-14	36	3

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