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

Tornier — Predicate Candidate Screening

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

90 daysmedian FDA review time

318 days90th percentile

44clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K112144	AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDE	Tornier	2012-03-13	231	0
K111970	KNEETEC PFJ&HLS KNEETEC PATELLAR COMPONENT	Tornier	2012-02-23	227	0
K111902	AEQUALIS SHOULDER SYSTEM	Tornier	2011-11-03	121	0
K094013	HLS KNEETEC SYSTEM	Tornier	2011-05-05	492	0
K100142	AEQUALIS REVERSED SHOULDER PROSTHESIS	Tornier	2010-05-06	107	0
K091870	TORNIER, PITON FIXATION IMPLANT SYSTEM	Tornier	2009-09-21	90	0
K090076	SALTO TALARIS TOTAL ANKLE PROSTHESIS	Tornier	2009-03-17	64	0
K082754	AEQUALIS HUMERAL NAIL SYSTEM	Tornier	2009-01-27	130	1
K082120	AEQUALIS REVERSED FRACTURE SHOULDER PROTHESIS	Tornier	2008-10-24	88	0
K081059	AEQUALIS REVERSED SHOULDER PROSTHESIS	Tornier	2008-07-17	94	0
K071948	AEQUALIS REVERSED ADAPTER	Tornier	2007-10-18	97	0
K070787	LATITUDE ELBOW PROTHESIS	Tornier	2007-08-24	155	0
K062661	AEQUALIS RESURFACING HEAD	Tornier	2006-12-22	106	0
K063551	AEQUALIS HUMERAL PLATE	Tornier	2006-12-22	28	0
K060544	SALTO TALARIS TOTAL ANKLE PROSTHESIS	Tornier	2006-11-13	257	0
K063081	AEQUALIS SHOULDER SYSTEM	Tornier	2006-11-09	30	0
K061824	TORNIER CEMENT RESTRICTOR	Tornier	2006-09-14	78	0
K061439	AEQUALIS REVERSED PROSTHESIS	Tornier	2006-07-20	57	0
K060545	UNITY HUMERAL PLATE	Tornier	2006-04-21	51	0
K060438	RHS	Tornier	2006-04-18	56	0
K060209	AEQUALIS SHOULDER FRACTURE SYSTEM & AEQUALIS SHOULDER SYSTEM	Tornier	2006-03-02	34	0
K050848	TORNIER ELBOW PROSTHESIS	Tornier	2005-07-14	101	0
K050316	AEQUALIS REVERSED SHOULDER PROSTHESIS	Tornier	2005-03-16	35	0
K043077	MODIFICATION TO AEQUALIS SHOULDER FRACTURE SYSTEM; AEQUALIS	Tornier	2004-12-17	39	0
K041873	AEQUALIS REVERSED SHOULDER PROSTHESIS	Tornier	2004-08-25	44	0
K041339	AEQUALIS SHOULDER SYSTEM	Tornier	2004-06-17	28	0
K030941	AEQUALIS REVERSED SHOULDER PROSTHESIS	Tornier	2004-05-14	416	0
K032679	AEQUALIS SHOULDER FRACTURE SYSTEM	Tornier	2003-12-15	108	0
K032079	HLS NOETOS SYSTEM	Tornier	2003-10-02	87	0
K022211	HLS UNI EVOLUTION PROSTHESIS	Tornier	2003-05-22	318	0
K031218	MODIFICATION TO TORNIER TOTAL ELBOW PROSTHESIS	Tornier	2003-05-16	29	0
K013906	HLS NOETOS SYSTEM	Tornier	2002-07-17	233	0
K012212	MODIFICATION TO AEQUALIS SHOULDER SYSTEM	Tornier	2001-08-15	30	0
K011942	AEQUALIS PRESS-FIT SHOULDER PROSTHESIS	Tornier	2001-07-13	22	0
K011567	TORNIER TOTAL ELBOW PROSTHESIS	Tornier	2001-06-19	29	0
K003728	MODIFICATION TO AEQUALIS SHOULDER FRACTURE SYSTEM	Tornier	2000-12-20	16	0
K000003	TORNIER TOTAL ELBOW PROSTHESIS	Tornier	2000-10-02	273	0
K001932	TORNIER CEMENT RESTRICTOR	Tornier	2000-07-20	24	0
K994393	AEQUALIS UNIVERSAL SHOULDER GLENOID	Tornier	2000-06-22	177	0
K994392	AEQUALIS SHOULDER FRACTURE SYSTEM	Tornier	2000-03-10	73	0
K980244	AEQUALIS SHOULDER PROSTHESIS	Tornier	1999-08-23	577	0
K970829	PHUSIS ABSORBABLE INTERFERENCE SCREW	Tornier	1998-12-22	656	0
K973453	TORNIER CEMENT RESTRICTOR	Tornier	1997-12-09	89	0
K952928	AEQUALIS SHOULDER SYSTEM FOR TOTAL & HEMISHOULDER APPLICATIO	Tornier	1995-09-27	93	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