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

TriMed, Inc. — Predicate Candidate Screening

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

86 daysmedian FDA review time

164 days90th percentile

37clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K262032	TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed No	TriMed, Inc.	2026-07-16	29	0
K261241	TriMed Compression Screws	TriMed, Inc.	2026-05-14	29	0
K254002	TriMed Volar Bearing Plates (VBEAL-13-7S); TriMed Volar Bear	TriMed, Inc.	2026-01-15	31	0
K252061	Distal Xtremities System	TriMed, Inc.	2025-08-20	50	0
K251134	RipCord	TriMed, Inc.	2025-07-11	91	0
K251945	TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)	TriMed, Inc.	2025-07-10	15	0
K250929	TriMed Ulnar Osteotomy System (Ulnar Osteotomy Compression P	TriMed, Inc.	2025-06-26	90	0
K250935	TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); Tri	TriMed, Inc.	2025-05-22	55	0
K243943	TriMed® Compression Screws	TriMed, Inc.	2025-04-10	111	0
K250948	TriMed Fusion Cup System	TriMed, Inc.	2025-04-08	18	0
K243999	TriMed Ankle Fixation System	TriMed, Inc.	2025-03-19	83	0
K243987	TriMed Elbow and Forearm System	TriMed, Inc.	2025-03-19	86	0
K243569	TriMed Wrist Fixation System (Volar Bearing Plates); TriMed	TriMed, Inc.	2025-01-15	58	0
K243050	TriMed Posterior Malleolus Fixation System	TriMed, Inc.	2024-11-26	60	0
K241942	TriMed Bridge Plates	TriMed, Inc.	2024-09-17	77	0
K233863	TriMed ASET Foot Plating System (1ST MTP 9-hole Long Plate),	TriMed, Inc.	2024-04-17	133	0
K234040	TriMed Threaded Intramedullary Nail System	TriMed, Inc.	2024-01-18	28	2
K230805	TriMed Clavicle Fixation System	TriMed, Inc.	2023-09-01	162	0
K230749	TriMed Threaded Intramedullary Nail System	TriMed, Inc.	2023-04-17	31	0
K222637	TriMed Wrist Fixation System 3	TriMed, Inc.	2022-12-21	112	1
K220650	TriMed Ripcord Device	TriMed, Inc.	2022-06-01	86	1
K211783	TriMed Threaded Intramedullary Nail System	TriMed, Inc.	2021-08-06	58	0
K192696	TriMed ASET Foot Plating System	TriMed, Inc.	2020-01-05	101	0
K190166	TriMed Nitinol Staple System	TriMed, Inc.	2019-07-01	151	0
K151735	TriMed Humeral Supracondylar Fixation System	TriMed, Inc.	2016-01-29	217	0
K112794	EOS SMALL BONE FIXATION SYSTEM	TriMed, Inc.	2012-05-10	227	0
K112509	TRIMED CLAVICLE FIXATION SYSTEM	TriMed, Inc.	2011-11-04	66	0
K111266	EASYLOCK OSTEOSYSTEM	TriMed, Inc.	2011-10-06	155	0
K102785	TRIMED RADIOCARPAL FUSION SYSTEM	TriMed, Inc.	2011-08-19	326	0
K101375	TRIMED X-FIX	TriMed, Inc.	2010-09-15	121	0
K093676	OMNITECH LARGE, TRIMED COMPRESSION SCREW	TriMed, Inc.	2010-03-17	110	0
K091156	TRIMED STERILE PRODUCT	TriMed, Inc.	2009-07-15	85	0
K081348	TENODESIS CROSS SCREW, INTERFERENCE SCREW, SUTURE BEAD	TriMed, Inc.	2008-10-17	156	0
K071876	CROSS.BONE	TriMed, Inc.	2007-12-17	164	0
K060041	TRIMED BONE PLATES	TriMed, Inc.	2006-02-07	32	0
K050681	OMNITECH SYSTEM & EASY LOCK OSTEOSYSTEM WITH XTREMITIES PLAT	TriMed, Inc.	2005-07-27	133	0
K043263	TRIMED OSTEOTOMY PLATE	TriMed, Inc.	2005-01-14	51	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