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

KYJ — Predicate Candidate Screening

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

194 daysmedian FDA review time

441 days90th percentile

14clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K233670	Ascension Silicone MCP; Ascension Silicone PIP	Ascension Orthopedics, Inc.	2023-12-14	29	0
K220142	BRM Digitalis Spacer	Brm Extremities Srl	2023-04-04	441	0
K211385	KeriFlex® MCP and PIP Finger Joint Prostheses	Keri Medical SA	2022-07-27	449	0
K140453	OSTEOTEC SILICONE FINGER IMPLANT	Osteotec, Ltd.	2015-04-17	417	1
K083107	MODIFICATION TO DEPUY NEUFLEX PIP FINGER	DePuy Orthopaedics, Inc.	2009-02-09	112	0
K082231	ASCENSION SILICONE PIP	Ascension Orthopedics, Inc.	2009-01-12	158	0
K022892	ASCENSION SILLICONE MCP	Ascension Orthopedics, Inc.	2002-11-25	87	0
K013629	FINGER JOINT PROSTHESIS	Avanta Orthopaedics, Inc.	2002-01-25	81	0
K001922	DEPUY NEUFLEX PIP FINGER	Depuy, Inc.	2000-08-29	67	0
K970544	DEPUY DUPONT ORTHOPAEDICS FINGER JOINT PROSTHESIS	Depuy, Inc.	1997-09-12	212	0
K931588	SUTTER PROXIMAL INTERPHALANGEAL JOINT	Sutter Corp.	1994-03-10	344	0
K870200	SUTTER FINGER JOINT PROSTHESIS	Sutter Biomedical, Inc.	1987-10-09	262	0
K781380	MARNE M.T.P.J. ORTHOPEDIC IMPLANT	Farah , Ltd.	1979-02-21	194	0
K781668	GAMMA RADIATION STERILIZATION PRECEDURE	Cutter Laboratories, Inc.	1978-11-03	36	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