TriMed, Inc.
Medical device manufacturer in Santa Clarita, CA.
38510(k) clearances
0PMA approvals
19recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K262344 | Large Compression ScrewsHWC · Special | 08/12/2026SE |
| K262032 | TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion…HRS · Special | 07/16/2026SE |
| K261241 | TriMed Compression ScrewsHWC · Special | 05/14/2026SE |
| K254002 | TriMed Volar Bearing Plates (VBEAL-13-7S); TriMed Volar Bearing Plates (VBEAR-13-7S)…HRS · Special | 01/15/2026SE |
| K252061 | Distal Xtremities SystemHRS · Traditional | 08/20/2025SE |
| K251134 | RipCordHTN · Traditional | 07/11/2025SE |
| K251945 | TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)HRS · Special | 07/10/2025SE |
| K250929 | TriMed Ulnar Osteotomy System (Ulnar Osteotomy Compression Plate); TriMed Ulnar…HRS · Traditional | 06/26/2025SE |
| K250935 | TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal System…HRS · Traditional | 05/22/2025SE |
| K243943 | TriMed® Compression ScrewsHWC · Traditional | 04/10/2025SE |
| K250948 | TriMed Fusion Cup SystemHRS · Special | 04/08/2025SE |
| K243999 | TriMed Ankle Fixation SystemHRS · Traditional | 03/19/2025SE |
| K243987 | TriMed Elbow and Forearm SystemHRS · Traditional | 03/19/2025SE |
| K243569 | TriMed Wrist Fixation System (Volar Bearing Plates); TriMed Wrist Fixation System (Volar…HRS · Traditional | 01/15/2025SE |
| K243050 | TriMed Posterior Malleolus Fixation SystemHRS · Traditional | 11/26/2024SE |
| K241942 | TriMed Bridge PlatesHRS · Traditional | 09/17/2024SE |
| K233863 | TriMed ASET Foot Plating System (1ST MTP 9-hole Long Plate), TriMed ASET Foot Plating…HRS · Traditional | 04/17/2024SE |
| K234040 | TriMed Threaded Intramedullary Nail SystemHWC · Special | 01/18/2024SE |
| K230805 | TriMed Clavicle Fixation SystemHRS · Traditional | 09/01/2023SE |
| K230749 | TriMed Threaded Intramedullary Nail SystemHWC · Special | 04/17/2023SE |
| K222637 | TriMed Wrist Fixation System 3HRS · Traditional | 12/21/2022SE |
| K220650 | TriMed Ripcord DeviceHTN · Traditional | 06/01/2022SE |
| K211783 | TriMed Threaded Intramedullary Nail SystemHWC · Traditional | 08/06/2021SE |
| K192696 | TriMed ASET Foot Plating SystemHRS · Traditional | 01/05/2020SE |
| K190166 | TriMed Nitinol Staple SystemJDR · Traditional | 07/01/2019SE |
| K151735 | TriMed Humeral Supracondylar Fixation SystemHRS · Traditional | 01/29/2016SE |
| K112794 | Eos Small Bone Fixation SystemHRS · Traditional | 05/10/2012SE |
| K112509 | Trimed Clavicle Fixation SystemHRS · Traditional | 11/04/2011SE |
| K111266 | Easylock OsteosystemHRS · Traditional | 10/06/2011SE |
| K102785 | Trimed Radiocarpal Fusion SystemHRS · Traditional | 08/19/2011SE |
| K101375 | Trimed X-FixNDK · Traditional | 09/15/2010SE |
| K093676 | Omnitech Large, Trimed Compression ScrewHWC · Traditional | 03/17/2010SE |
| K091156 | Trimed Sterile ProductHRS · Special | 07/15/2009SE |
| K081348 | Tenodesis Cross Screw, Interference Screw, Suture BeadMBI · Traditional | 10/17/2008SE |
| K071876 | Cross.BoneMQV · Traditional | 12/17/2007SE |
| K060041 | Trimed Bone PlatesHRS · Traditional | 02/07/2006SE |
| K050681 | Omnitech System & Easy Lock Osteosystem with Xtremities PlatesHRS · Traditional | 07/27/2005SE |
| K043263 | Trimed Osteotomy PlateHRS · Traditional | 01/14/2005SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1792-2024 Class II | TriMed, Threaded IM Nail 3.6mm, 60mm, TI, Ref: IMN3.6-60 T, Non Sterile, MD, Rx Only…Nail system contains an out of specification driver-socket which could result in inability to pick up nails… | 03/19/2024Open, Classified |
| Z-1791-2024 Class II | TriMed, Threaded IM Nail 3.6mm, 60mm, TI, Ref: IMN3.6-60 T, Non Sterile, MD, Rx Only…Nail system contains an out of specification driver-socket which could result in inability to pick up nails… | 03/19/2024Open, Classified |
| Z-0932-2024 Class II | Volar Bearing Plate. REF: VBEAL-3-7N, VBEAL-5-7N, VBEAL-3-7S, VBEAL-5-7S, VBEAL-7-7S…Plates, part of a wrist fixation system, are affixed during surgery with bearings that may pop out from… | 11/28/2023Open, Classified |
| Z-1101-2023 Class II | RipCord Syndesmosis Button, REF: STA001KOverly aggressive tension on the pull suture, while passing the medial button through a bone/soft tissue… | 12/22/2022Open, Classified |
| Z-0359-2020 Class II | TriMed Wrist Hook Dorsal Impactor, REF IMPCT-WHD; and TriMed Wrist Hook Volar Impactor…The WHD/WHV impactors can rust over time due to an improper manufacturing process. | 09/28/2018Open, Classified |
| Z-0358-2020 Class II | TriMed Peg Guide Extender, REF PEG-XTNDR, nonsterile, Rx. The firm name on the label is…The spring on the PEG-Extender can rust due to the type of steel used to manufacture it. | 09/28/2018Open, Classified |
| Z-0357-2020 Class II | TriMed Hex Driver 1.2, 55mm AO Cannulated, REF HXDRIVR-1.2C AO, nonsterile, Rx. The firm…The epoxy on Apex manufactured epoxy-coated instruments can pop off. | 09/28/2018Open, Classified |
| Z-0356-2020 Class II | TriMed Locking Drill Guide, 2.3mm, REF GUIDELCBS-2.3, nonsterile, Rx. The firm name on…The epoxy on Apex manufactured epoxy-coated instruments can pop off. | 09/28/2018Open, Classified |
| Z-0355-2020 Class II | TriMed Countersink 1.7mm, HCS, REF HSINK-1.7, nonsterile, Rx. The firm name on the label…The epoxy on Apex manufactured epoxy-coated instruments can pop off. | 09/28/2018Open, Classified |
| Z-1214-2019 Class II | TriMed Hex Cortical Screw 4.0, 40 mm, REF HEX4.0-40, non-Sterile, RX, a component of the…The bone screw is shorter than the intended design specification. | 08/24/2018Terminated |
| Z-0118-2020 Class II | TriMed Dorsal Wrist Hook Plate, Dorsal, 4-Hole, REF WHD-4, contained in a tray, insert…Modifications to the specification were not appropriately qualified through the company's design control… | 08/24/2018Terminated |
| Z-0366-2020 Class II | TriMed Olecranon Hook Plate, Lt, 6-Holes, REF: OHOOKL-6, Non-Sterile, RX only, (01)…The firm has become aware that the angled-hole of certain semi-tubular design bone plates may have been… | 08/15/2018Terminated |
| Z-2877-2018 Class II | Ulnar Osteotomy Compression Plate, Short Model: UOCP-S Product Usage: The UOCP-S is…Two instrument holes located on the side of the plate, which act to align the saw guide are located on the… | 04/16/2018Terminated |
| Z-2265-2018 Class II | Nitinol Staple, Elastic Staple Small-Symmetrical, Sterile R, Model #: a) ES-08x08; b)…During a retrospective review of sterilization records, TriMed has determined that evidence of quarterly… | 04/13/2018Terminated |
| Z-2264-2018 Class II | Nitinol Staple, Elastic Staple Small-Asymmetrical, Sterile R, Model #: a) ES-10x13x15…During a retrospective review of sterilization records, TriMed has determined that evidence of quarterly… | 04/13/2018Terminated |
| Z-2263-2018 Class II | Nitinol Staple, Elastic Staple Large-Symmetrical, Sterile R, Model #: a) ES-18x14; b)…During a retrospective review of sterilization records, TriMed has determined that evidence of quarterly… | 04/13/2018Terminated |
| Z-2262-2018 Class II | Nitinol Staple, Elastic Staple Large-Asymmetrical, Sterile R, Model #: a) ES-18x15x17…During a retrospective review of sterilization records, TriMed has determined that evidence of quarterly… | 04/13/2018Terminated |
| Z-1373-2018 Class II | Hex Driver Part Number HXDRIVER-2.0 AO; Hex Driver Part Number HXDRIVR-2.5 AO; Hex…Following the completion of sterilization cycle(s) of the impacted Hex Driver, the epoxy color band on the… | 01/11/2018Terminated |
| Z-2849-2016 Class II | TriMed Semi-Tubular Plate, 10-Hole, Model No. SMTP-10 Contoured plate with offset screw…TriMed is recalling the Semi-Tubular Plates with 10 holes (SMTP-10) because a non-locking screw passed… | 08/29/2016Terminated |