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

Tornier, Inc. — Predicate Candidate Screening

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

113 daysmedian FDA review time

254 days90th percentile

52clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K260721	Tornier Perform Advanced Glenoid	Tornier, Inc.	2026-07-22	139	0
K252788	Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)	Tornier, Inc.	2026-01-08	128	0
K251686	Tornier Humeral Reconstruction System Max (Tornier HRS Max)	Tornier, Inc.	2025-10-30	150	1
K230352	Tornier Humeral Nail and Tornier Long Humeral Nail	Tornier, Inc.	2023-10-31	264	0
K220914	Tornier Perform Humeral System – Fracture	Tornier, Inc.	2022-10-14	198	0
K220418	Tornier Perform Humeral System – Stemless	Tornier, Inc.	2022-09-14	212	1
K211359	Tornier Perform™ Patient-Matched Primary Reversed Glenoid an	Tornier, Inc.	2021-11-12	193	2
K213124	Tomier Perform™ Reversed Glenoid Cannulated Glenospheres	Tornier, Inc.	2021-10-26	29	0
K201315	PERFORM Humeral System – Stem	Tornier, Inc.	2020-09-11	116	1
K193247	LATITUDE EV™ Total Elbow Arthroplasty	Tornier, Inc.	2020-08-05	254	0
K191711	ORTHOLOC™ SPS Shoulder Plating System	Tornier, Inc.	2019-07-17	21	0
K191318	AEQUALIS FLEX REVIVE Shoulder System	Tornier, Inc.	2019-06-14	30	2
K183696	Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Revers	Tornier, Inc.	2019-01-30	30	1
K182461	LATITUDE EV Total Elbow Arthroplasty	Tornier, Inc.	2018-12-27	108	0
K181587	ORTHOLOC SPS Shoulder Plating System	Tornier, Inc.	2018-10-05	112	0
K181420	Aequalis Flex Revive Shoulder System	Tornier, Inc.	2018-09-20	112	0
K171010	Latitude EV Total Elbow Arthroplasty	Tornier, Inc.	2017-08-31	149	0
K161742	Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoi	Tornier, Inc.	2016-11-15	144	2
K160975	Aequalis PerFORM+ Shoulder System	Tornier, Inc.	2016-06-10	64	0
K150871	ForeFoot STP System	Tornier, Inc.	2015-08-04	125	0
K150715	2.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture Anch	Tornier, Inc.	2015-07-28	131	0
K150583	Aequalis PerFORM+ Shoulder System	Tornier, Inc.	2015-04-23	45	0
K143552	Simpliciti Shoulder System	Tornier, Inc.	2015-03-04	79	0
K141029	TORNIER AEQUALIS ADJUSTABLE REVERSE SHOULDER SYSTEM	Tornier, Inc.	2014-06-18	57	0
K133777	TORNIER INSITE(TM) FT PEEK KNOTLESS SUTURE ANCHOR	Tornier, Inc.	2014-04-04	113	0
K133376	AEQUALIS HUMERAL NAIL; SIZES 7MM & 8MM X 210, 230, 250, 270M	Tornier, Inc.	2013-12-05	31	0
K132632	TORNIER INSITE FT SUTURE ANCHOR WITH NEEDLES	Tornier, Inc.	2013-09-19	28	0
K122635	TORNIER INSITE FT BIOCOMPOSITE SUTURE ANCHOR	Tornier, Inc.	2013-05-13	257	0
K130422	PHANTOM FIBER BIOFIBER SUTURE	Tornier, Inc.	2013-04-04	43	0
K122487	BIOFIBER SYTURE	Tornier, Inc.	2012-09-17	33	0
K120262	HLS UNI EVOLUTION & U-KNEETEC	Tornier, Inc.	2012-07-25	180	0
K120739	AEQUALIS ADJUSTABLE MODULAR REVERSE SHOULDER SYSTEM	Tornier, Inc.	2012-07-05	115	0
K121493	ASCEND SHOULDER SYSTEM	Tornier, Inc.	2012-06-20	30	0
K120794	ASCEND SHOULDER SYSTEM	Tornier, Inc.	2012-04-13	29	0
K113413	ASCEND SHOULDER SYSTEM	Tornier, Inc.	2012-03-09	112	0
K111337	TORNIER COLLAGEN COATED BIOFIBER SCAFFOLD	Tornier, Inc.	2012-01-25	258	0
K112615	AEQUALIS ASCEND MODULAR REVERSE SHOULDER SYSTEM	Tornier, Inc.	2011-10-11	33	0
K110599	AEQUALIS ASCEND MODULAR REVERSE SHOULDER SYSTEM	Tornier, Inc.	2011-06-14	104	0
K110773	TORNIER INSITE FT SUTURE ANCHOR	Tornier, Inc.	2011-06-02	73	0
K102788	TORNIER BIOFIBER SCAFFOLD	Tornier, Inc.	2011-05-10	228	0
K110865	AEQUALIS ASCEND MODULAR ANATOMIC SHOULDER SYSTEM	Tornier, Inc.	2011-04-27	29	0
K103262	QUICKDRAW CONVERTIBLE FIXATION IMPLANT SYSTEM	Tornier, Inc.	2011-04-05	152	0
K102924	AEQUALIS ASCEND MODULAR ANATOMIC SHOULDER SYSTEM	Tornier, Inc.	2011-01-31	123	0
K103007	AFFINITI TOTAL AND HEMI-SHOULDER SYSTEM	Tornier, Inc.	2010-11-09	28	0
K100562	LATITUDE ELBOW PROSTHESIS	Tornier, Inc.	2010-06-29	120	2
K093799	TORNIER SURGICAL MESH	Tornier, Inc.	2010-04-22	133	0
K090139	ANKLE ARTHRODESIS PLATE SYSTEM	Tornier, Inc.	2009-10-27	279	0
K090582	CALCANEAL FRACTURE PLATE SYSTEM	Tornier, Inc.	2009-07-02	120	0
K083268	TORNIER, INC., INSITE SUTURE ANCHORS	Tornier, Inc.	2009-02-12	99	0
K081707	AEQUALIS SHOULDER FRACTURE AND SHOULDER SYSTEMS	Tornier, Inc.	2008-07-17	30	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