ClearanceBrief
Company · US

TriMed, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 2005 to 2026. Name variants (Inc, Corp, punctuation) are merged.

38510(k) clearances (4 in 12 months)
19recalls (0 in 12 months)
13recalls that name a 510(k)

Product codes

CodeDeviceRecords
HRSPlate, Fixation, Bone31
HWCScrew, Fixation, Bone9
LXHOrthopedic Manual Surgical Instrument6
JDRStaple, Fixation, Bone5
HTNWasher, Bolt Nut3
MBIFastener, Fixation, Nondegradable, Soft Tissue1
MQVFiller, Bone Void, Calcium Compound1
NDKSystem, External Fixator (With Metallic Invasive Components)1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Aug 12, 2026K262344Large Compression Screws
TriMed, Inc.
HWC
Jul 16, 2026K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spannin
TriMed, Inc.
HRS
May 14, 2026K261241TriMed Compression Screws
TriMed, Inc.
HWC
Jan 15, 2026K254002TriMed Volar Bearing Plates (VBEAL-13-7S); TriMed Volar Bearing Plates (VBEAR-13-7S); TriMed Volar Bearing Plates (VBEAL
TriMed, Inc.
HRS
Aug 20, 2025K252061Distal Xtremities System
TriMed, Inc.
HRS
Jul 11, 2025K251134RipCord
TriMed, Inc.
HTN
Jul 10, 2025K251945TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)
TriMed, Inc.
HRS
Jun 26, 2025K250929TriMed Ulnar Osteotomy System (Ulnar Osteotomy Compression Plate); TriMed Ulnar Osteotomy System (Hex Cortical Screw 3.2
TriMed, Inc.
HRS
May 22, 2025K250935TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal System (Fifth Metatarsal Screw)
TriMed, Inc.
HRS
Apr 10, 2025K243943TriMed® Compression Screws
TriMed, Inc.
HWC
Apr 8, 2025K250948TriMed Fusion Cup System
TriMed, Inc.
HRS
Mar 19, 2025K243999TriMed Ankle Fixation System
TriMed, Inc.
HRS
Mar 19, 2025K243987TriMed Elbow and Forearm System
TriMed, Inc.
HRS
Jan 15, 2025K243569TriMed Wrist Fixation System (Volar Bearing Plates); TriMed Wrist Fixation System (Volar Fixed Angle Plates); TriMed Wri
TriMed, Inc.
HRS
Nov 26, 2024K243050TriMed Posterior Malleolus Fixation System
TriMed, Inc.
HRS
Sep 17, 2024K241942TriMed Bridge Plates
TriMed, Inc.
HRS
Apr 17, 2024K233863TriMed ASET Foot Plating System (1ST MTP 9-hole Long Plate), TriMed ASET Foot Plating System (1st Met Osteotomy Plate),
TriMed, Inc.
HRS
Jan 18, 2024K234040TriMed Threaded Intramedullary Nail System
TriMed, Inc.
HWC
Sep 1, 2023K230805TriMed Clavicle Fixation System
TriMed, Inc.
HRS
Apr 17, 2023K230749TriMed Threaded Intramedullary Nail System
TriMed, Inc.
HWC
Dec 21, 2022K222637TriMed Wrist Fixation System 3
TriMed, Inc.
HRS
Jun 1, 2022K220650TriMed Ripcord Device
TriMed, Inc.
HTN
Aug 6, 2021K211783TriMed Threaded Intramedullary Nail System
TriMed, Inc.
HWC
Jan 5, 2020K192696TriMed ASET Foot Plating System
TriMed, Inc.
HRS
Jul 1, 2019K190166TriMed Nitinol Staple System
TriMed, Inc.
JDR
Jan 29, 2016K151735TriMed Humeral Supracondylar Fixation System
TriMed, Inc.
HRS
May 10, 2012K112794EOS SMALL BONE FIXATION SYSTEM
TriMed, Inc.
HRS
Nov 4, 2011K112509TRIMED CLAVICLE FIXATION SYSTEM
TriMed, Inc.
HRS
Oct 6, 2011K111266EASYLOCK OSTEOSYSTEM
TriMed, Inc.
HRS
Aug 19, 2011K102785TRIMED RADIOCARPAL FUSION SYSTEM
TriMed, Inc.
HRS
Sep 15, 2010K101375TRIMED X-FIX
TriMed, Inc.
NDK
Mar 17, 2010K093676OMNITECH LARGE, TRIMED COMPRESSION SCREW
TriMed, Inc.
HWC
Jul 15, 2009K091156TRIMED STERILE PRODUCT
TriMed, Inc.
HRS
Oct 17, 2008K081348TENODESIS CROSS SCREW, INTERFERENCE SCREW, SUTURE BEAD
TriMed, Inc.
MBI
Dec 17, 2007K071876CROSS.BONE
TriMed, Inc.
MQV
Feb 7, 2006K060041TRIMED BONE PLATES
TriMed, Inc.
HRS
Jul 27, 2005K050681OMNITECH SYSTEM & EASY LOCK OSTEOSYSTEM WITH XTREMITIES PLATES
TriMed, Inc.
HRS
Jan 14, 2005K043263TRIMED OSTEOTOMY PLATE
TriMed, Inc.
HRS

Latest recalls

DateFirm and productCodeLinked 510(k)
May 10, 2024TriMed Inc.
TriMed, Threaded IM Nail 3.6mm, 60mm, TI, Ref: IMN3.6-60 T, Non Sterile, MD, Rx Only TriMed, Threaded IM Nail 3.6mm, 65mm, TI, Ref: IMN3.6-65 T, Non Sterile, MD, Rx Only
Open, Classified		 HWCK234040
May 10, 2024TriMed Inc.
TriMed, Threaded IM Nail 3.6mm, 60mm, TI, Ref: IMN3.6-60 T, Non Sterile, MD, Rx Only TriMed, Threaded IM Nail 3.6mm, 65mm, TI, Ref: IMN3.6-65 T, Non Sterile, MD, Rx Only
Open, Classified		 HWCK234040
Jan 31, 2024TriMed Inc.
Volar Bearing Plate. REF: VBEAL-3-7N, VBEAL-5-7N, VBEAL-3-7S, VBEAL-5-7S, VBEAL-7-7S, VBEAL-3-7W, VBEAL-5-7W, VBEAR-3-7N, VBEAR-5-7-N, VBEAR-3-7S, VBEAR-5-7S, VBEAR-7-7S, VBEAR-3-7W, VBEAR-5-7W. In
Open, Classified		 HRSK222637
Feb 7, 2023TriMed Inc.
RipCord Syndesmosis Button, REF: STA001K
Open, Classified		 HTNK220650
Oct 10, 2019TriMed Inc.
TriMed Dorsal Wrist Hook Plate, Dorsal, 4-Hole, REF WHD-4, contained in a tray, insert, or poly package containing varying amounts, Nonsterile, Single Use Only, Rx. The firm name on the label is TriM
Terminated		 HRSK951302
Sep 28, 2018TriMed Inc.
TriMed Wrist Hook Dorsal Impactor, REF IMPCT-WHD; and TriMed Wrist Hook Volar Impactor, REF IMPCT-WHV, both nonsterile, Rx, The firm name on the labels is TriMed Inc., Santa Clarita, CA.
Open, Classified		 LXHNone listed
Sep 28, 2018TriMed Inc.
TriMed Peg Guide Extender, REF PEG-XTNDR, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.
Open, Classified		 LXHNone listed
Sep 28, 2018TriMed Inc.
TriMed Hex Driver 1.2, 55mm AO Cannulated, REF HXDRIVR-1.2C AO, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.
Open, Classified		 LXHNone listed
Sep 28, 2018TriMed Inc.
TriMed Locking Drill Guide, 2.3mm, REF GUIDELCBS-2.3, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.
Open, Classified		 LXHNone listed
Sep 28, 2018TriMed Inc.
TriMed Countersink 1.7mm, HCS, REF HSINK-1.7, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.
Open, Classified		 LXHNone listed
Aug 24, 2018TriMed Inc.
TriMed Hex Cortical Screw 4.0, 40 mm, REF HEX4.0-40, non-Sterile, RX, a component of the TriMed Ankle Fixation System. The HEX4.0 40 bone screw is a component of the TriMed Ankle Fixation System. Th
Terminated		 HRSK060041
Aug 15, 2018TriMed Inc.
TriMed Olecranon Hook Plate, Lt, 6-Holes, REF: OHOOKL-6, Non-Sterile, RX only, (01) 00842188101281 - Product Usage: The OHOOKL is a semi-tubular design bone plate with two offset intramedullary tines
Terminated		 HRSK060041
Apr 16, 2018TriMed Inc.
Ulnar Osteotomy Compression Plate, Short Model: UOCP-S Product Usage: The UOCP-S is provided non-sterile with the required fixation screws and surgical instrumentation. The TriMed Ulnar Osteotomy Pla
Terminated		 HRSK043263
Apr 13, 2018TriMed Inc.
Nitinol Staple, Elastic Staple Small-Symmetrical, Sterile R, Model #: a) ES-08x08; b) ES-10x10; c) ES-10x13; d) ES-12x10; e) ES-15x12; f) ES-10x14; g) ES-10x15
Terminated		 JDRK112794
Apr 13, 2018TriMed Inc.
Nitinol Staple, Elastic Staple Small-Asymmetrical, Sterile R, Model #: a) ES-10x13x15; b) ES-10x16x19; c) ES-10x17x19; d) ES-12x13x15; e) ES-12x15x17; f) ES-12x16x19; g) ES-15x13x16
Terminated		 JDRK112794
Apr 13, 2018TriMed Inc.
Nitinol Staple, Elastic Staple Large-Symmetrical, Sterile R, Model #: a) ES-18x14; b) ES-20x20; c) ES-25x22
Terminated		 JDRK112794
Apr 13, 2018TriMed Inc.
Nitinol Staple, Elastic Staple Large-Asymmetrical, Sterile R, Model #: a) ES-18x15x17; b) ES-18x17x19
Terminated		 JDRK112794
Jan 11, 2018TriMed Inc.
Hex Driver Part Number HXDRIVER-2.0 AO; Hex Driver Part Number HXDRIVR-2.5 AO; Hex Driver Part Number HXDRIVR-2.5CL AO; Hex Driver Part Number DVHX-2.5/130C AO; Hex Driver Part Number HXDRIVR-3.0 AO;
Terminated		 LXHNone listed
Aug 29, 2016Trimed Inc
TriMed Semi-Tubular Plate, 10-Hole, Model No. SMTP-10 Contoured plate with offset screw holes. The plate is 103 mm in length, 1.3 mm thick and 9.6 mm wide. The part is made of surgical steel conforma
Terminated		 HRSK060041
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