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

JDC · Predicate Candidate Screening

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

85 daysmedian FDA review time

256 days90th percentile

29clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K181362	TEMA Elbow System	Lima Corporate S.P.A.	2019-02-16	269	1
K181307	Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow	Zimmer, Inc.	2019-01-28	256	0
K153398	Comprehensive SRS/Nexel Elbow	Biomet Manufacturing Corp	2016-02-03	71	0
K150501	Zimmer Nexel Total Elbow Ulnar Cement Diverter	Zimmer, Inc.	2015-04-23	56	0
K123862	ZIMMER NEXEL TOTAL ELBOW	Zimmer, Inc.	2013-03-12	88	0
K090473	DISCOVERY ELBOW - X-SMALL	Biomet Manufacturing Corp	2009-03-25	29	0
K060696	ACCLAIM TOTAL ELBOW SYSTEM	DePuy Orthopaedics, Inc.	2006-04-14	29	0
K053189	COONRAD/MORREY TOTAL ELBOW, MODEL 8105 SERIES	Zimmer, Inc.	2005-12-09	24	2
K051975	POROUS COATED DISCOVERY ELBOW	Biomet, Inc.	2005-09-06	47	2
K042664	LPS UPPER EXTREMITY	Depuy, Inc.	2004-12-08	71	0
K040389	COONRAD/MORREY ELBOW CEMENT RESTRICTOR	Zimmer, Inc.	2004-05-17	90	1
K033280	DISCOVERY ELBOW-MOSAIC DISTAL HUMERAL REPLACEMENT SYSTEM	Biomet, Inc.	2003-12-19	70	0
K013042	DISCOVERY ELBOW	Biomet Orthopedics, Inc.	2001-10-10	30	3
K003253	BIOMET'S MINIMALLY CONSTRAINED ELBOW	Biomet, Inc.	2001-01-12	87	0
K000003	TORNIER TOTAL ELBOW PROSTHESIS	Tornier	2000-10-02	273	0
K001989	COONRAD/MORREY TOTAL ELBOW. MODEL 32-8105 SERIES	Zimmer, Inc.	2000-07-25	26	8
K000683	MODIFIED SINGLE AXLE TOTAL ELBOW	Biomet, Inc.	2000-06-27	119	0
K992656	DEPUY TOTAL ELBOW SYSTEM	DePuy Orthopaedics, Inc.	1999-11-05	88	2
K983036	SINGLE AXLE TOTAL ELBOW	Biomet, Inc.	1999-04-30	242	0
K982398	BIOMET 100% POROUS COATED BIAXIAL TOTAL ELBOW	Biomet, Inc.	1998-08-11	32	0
K980502	OSTEONICS TOTAL ELBOW SYSTEM	Osteonics Corp.	1998-05-05	85	0
K980428	BIOMET BIAXIAL TOTAL ELBOW	Biomet, Inc.	1998-05-05	90	0
K973357	COONRAD/MORREY TOTAL ELBOW, NEW HINGE PIN	Zimmer, Inc.	1998-03-02	175	1
K955916	TOWNLEY TOTAL ELBOW SYSTEM	Biologically Oriented Prostheses	1996-08-08	223	0
K901581	GSB ELBOW	Allo Pro Corp.	1990-10-22	201	0
K904021	PNEUMOTHORAX KIT, MODIFICATION	Arrow Intl., Inc.	1990-10-09	41	0
K883665	COONRAD III TOTAL ELBOW	Zimmer, Inc.	1989-02-03	161	0
K872084	POROCOAT MARK II TOTAL ELBOW	Depuy, Inc.	1987-06-25	27	0
K861680	OSTEONICS ELBOW PROSTHESIS	Osteonics Corp.	1986-06-27	57	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