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

JDB — Predicate Candidate Screening

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

90 daysmedian FDA review time

155 days90th percentile

27clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K222807	TEMA Elbow system - Line extension	Lima Corporate S.P.A.	2022-10-26	40	1
K193247	LATITUDE EV™ Total Elbow Arthroplasty	Tornier, Inc.	2020-08-05	254	0
K182461	LATITUDE EV Total Elbow Arthroplasty	Tornier, Inc.	2018-12-27	108	0
K171010	Latitude EV Total Elbow Arthroplasty	Tornier, Inc.	2017-08-31	149	0
K102180	RHEAD RADIAL HEAD EXTENDED STEMS	Small Bone Innovations, Inc.	2010-12-20	140	2
K100562	LATITUDE ELBOW PROSTHESIS	Tornier, Inc.	2010-06-29	120	2
K070787	LATITUDE ELBOW PROTHESIS	Tornier	2007-08-24	155	0
K070236	SBI LATERAL RADIO CAPITELLUM	Small Bone Innovations, Inc.	2007-02-21	27	2
K060438	RHS	Tornier	2006-04-18	56	0
K060038	SBI RADIO-CAPITELLAR IMPLANT	Small Bone Innovations, Inc.	2006-03-30	83	0
K050848	TORNIER ELBOW PROSTHESIS	Tornier	2005-07-14	101	0
K031218	MODIFICATION TO TORNIER TOTAL ELBOW PROSTHESIS	Tornier	2003-05-16	29	0
K011567	TORNIER TOTAL ELBOW PROSTHESIS	Tornier	2001-06-19	29	0
K983141	CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESIS	Johnson & Johnson Professionals, Inc.	1998-11-06	59	0
K972691	ABC TOTAL ELBOW PROTHESIS	Biomet, Inc.	1997-10-15	90	0
K960087	SORIBIE RESURFACING TOTAL ELBOW SYSTEM (PROPOSED NAME)	Wrightmedicaltechnologyinc	1996-09-20	253	0
K955099	SORBIE TOTAL ELBOW SYSTEM	Wrightmedicaltechnologyinc	1996-02-05	90	0
K880188	SOUTER STRATHCLYDE TOTAL ELBOW SYSTEM	Howmedica Corp.	1988-03-01	46	0
K873660	ROPER-TUKE ELBOW	Orthopedic Systems, Inc.	1988-01-06	118	0
K823473	POROCOAT MARK IV ELBOW	Depuy, Inc.	1983-01-20	59	0
K820957	SUFACE REPLACEMENT ELBOW	Howmedica Corp.	1982-07-02	87	0
K812322	ARIZONA RADIO CAPITELLAR TOTAL ELBOW	Zimmer, Inc.	1982-01-04	140	0
K811451	RADIAL HEAD PROSTHESIS	Cintor Orthopaedic Div.	1981-06-09	18	0
K810847	PRITCHARD SURFACE REPLACEMENT ELBOW	Depuy, Inc.	1981-05-01	35	0
K802348	TRIAXIAL	Johnson & Johnson Professionals, Inc.	1981-02-23	151	0
K802460	HELFET ELBOW PROSTHESIS	Depuy, Inc.	1980-11-19	42	0
K801574	DEPALMA ELBOW	Zimmer, Inc.	1980-10-31	114	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