Trimed Inc
Santa Clarita, CA, US
TRIMED, INC. appears in FDA device records in Santa Clarita, CA. FDA records list 38 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 19 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 38 510(k) clearances for Trimed Inc between 2005 and 2026. The busiest year on record is 2025, with 10. The most recent is 2026, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 2 |
| 2006 | 1 |
| 2007 | 1 |
| 2008 | 1 |
| 2009 | 1 |
| 2010 | 2 |
| 2011 | 3 |
| 2012 | 1 |
| 2016 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 2 |
| 2023 | 2 |
| 2024 | 4 |
| 2025 | 10 |
| 2026 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K262344 | Large Compression Screws | HWC | Substantially Equivalent | |
| K262032 | TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB ) | HRS | Substantially Equivalent | |
| K261241 | TriMed Compression Screws | HWC | Substantially Equivalent | |
| K254002 | TriMed Volar Bearing Plates (VBEAL-13-7S); TriMed Volar Bearing Plates (VBEAR-13-7S); TriMed Volar Bearing Plates (VBEAL-14-7S); TriMed Volar Bearing Plates (VBEAR-14-7S); TriMed Volar Bearing Plates (VBEAL-16-7S); TriMed Volar Bearing Plates (VBEAR-16-7S) | HRS | Substantially Equivalent | |
| K252061 | Distal Xtremities System | HRS | Substantially Equivalent | |
| K251134 | RipCord | HTN | Substantially Equivalent | |
| K251945 | TriMed Total Wrist Fusion System (Total Wrist Fusion Plate) | HRS | Substantially Equivalent | |
| K250929 | TriMed Ulnar Osteotomy System (Ulnar Osteotomy Compression Plate); TriMed Ulnar Osteotomy System (Hex Cortical Screw 3.2mm); TriMed Ulnar Osteotomy System (Locking Cortical Screw 3.2mm); TriMed Ulnar Osteotomy System (Lag Screw 3.2mm) | HRS | Substantially Equivalent | |
| K250935 | TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal System (Fifth Metatarsal Screw) | HRS | Substantially Equivalent | |
| K243943 | TriMed® Compression Screws | HWC | Substantially Equivalent | |
| K250948 | TriMed Fusion Cup System | HRS | Substantially Equivalent | |
| K243999 | TriMed Ankle Fixation System | HRS | Substantially Equivalent | |
| K243987 | TriMed Elbow and Forearm System | HRS | Substantially Equivalent | |
| K243569 | TriMed Wrist Fixation System (Volar Bearing Plates); TriMed Wrist Fixation System (Volar Fixed Angle Plates); TriMed Wrist Fixation System (Hook Plates); TriMed Wrist Fixation System (Pin Plates); TriMed Wrist Fixation System (Peg Plates); TriMed Wrist Fixation System (Shear Plates); TriMed Wrist Fixation System (Wireform plates and Washer); TriMed Wrist Fixation System (Wireforms); TriMed Wrist Fixation System (Torx Cortical Screws); TriMed Wrist Fixation System (Torx Threaded Pegs); | HRS | Substantially Equivalent | |
| K243050 | TriMed Posterior Malleolus Fixation System | HRS | Substantially Equivalent | |
| K241942 | TriMed Bridge Plates | HRS | Substantially Equivalent | |
| K233863 | TriMed ASET Foot Plating System (1ST MTP 9-hole Long Plate), TriMed ASET Foot Plating System (1st Met Osteotomy Plate), TriMed ASET Foot Plating System (H-Plate), TriMed ASET Foot Plating System (Talonavicular Plate), TriMed ASET Foot Plating System (Calcaneal Slide Osteotomy Plate), TriMed ASET Foot Plating System (Evans Osteotomy Plate), TriMed ASET Foot Plating System (Medial Column Fusion Plate), TriMed ASET Foot Plating System (Straight Plate), TriMed ASET Foot Plating System (T- | HRS | Substantially Equivalent | |
| K234040 | TriMed Threaded Intramedullary Nail System | HWC | Substantially Equivalent | |
| K230805 | TriMed Clavicle Fixation System | HRS | Substantially Equivalent | |
| K230749 | TriMed Threaded Intramedullary Nail System | HWC | Substantially Equivalent | |
| K222637 | TriMed Wrist Fixation System 3 | HRS | Substantially Equivalent | |
| K220650 | TriMed Ripcord Device | HTN | Substantially Equivalent | |
| K211783 | TriMed Threaded Intramedullary Nail System | HWC | Substantially Equivalent | |
| K192696 | TriMed ASET Foot Plating System | HRS | Substantially Equivalent | |
| K190166 | TriMed Nitinol Staple System | JDR | Substantially Equivalent | |
| K151735 | TriMed Humeral Supracondylar Fixation System | HRS | Substantially Equivalent | |
| K112794 | EOS SMALL BONE FIXATION SYSTEM | HRS | Substantially Equivalent | |
| K112509 | TRIMED CLAVICLE FIXATION SYSTEM | HRS | Substantially Equivalent | |
| K111266 | EASYLOCK OSTEOSYSTEM | HRS | Substantially Equivalent | |
| K102785 | TRIMED RADIOCARPAL FUSION SYSTEM | HRS | Substantially Equivalent | |
| K101375 | TRIMED X-FIX | NDK | Substantially Equivalent | |
| K093676 | OMNITECH LARGE, TRIMED COMPRESSION SCREW | HWC | Substantially Equivalent | |
| K091156 | TRIMED STERILE PRODUCT | HRS | Substantially Equivalent | |
| K081348 | TENODESIS CROSS SCREW, INTERFERENCE SCREW, SUTURE BEAD | MBI | Substantially Equivalent | |
| K071876 | CROSS.BONE | MQV | Substantially Equivalent | |
| K060041 | TRIMED BONE PLATES | HRS | Substantially Equivalent | |
| K050681 | OMNITECH SYSTEM & EASY LOCK OSTEOSYSTEM WITH XTREMITIES PLATES | HRS | Substantially Equivalent | |
| K043263 | TRIMED OSTEOTOMY PLATE | HRS | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2031009 | 3001236812 | TRIMED, INC. | 27533 Avenue Hopkins, Santa Clarita, CA 91355 US | 2026 | and 18 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- HTWBit, Drill
- GFABlade, Saw, General & Plastic Surgery, Surgical
- HTQBroach
- HWWCountersink
- HXZCutter, Wire
- GFCDriver, Surgical, Pin
- MBIFastener, Fixation, Nondegradable, Soft Tissue
- MQVFiller, Bone Void, Calcium Compound
- HTJGauge, Depth
- FZXGuide, Surgical, Instrument
- HWAImpactor
- HXPInstrument, Bending Or Contouring
- HWNInstrument, Compression
- JDSNail, Fixation, Bone
- LXHOrthopedic Manual Surgical Instrument
- HWQPasser
- HTYPin, Fixation, Smooth
- NDLPin, Fixation, Smooth, Metallic
- HRSPlate, Fixation, Bone
- KYJProsthesis, Finger, Constrained, Polymer
- HTOReamer
- HSBRod, Fixation, Intramedullary And Accessories
- HWCScrew, Fixation, Bone
- HXXScrewdriver
- JDRStaple, Fixation, Bone
- NDKSystem, External Fixator (With Metallic Invasive Components)
- HWXTap, Bone
- HWTTemplate
- FSMTray, Surgical, Instrument
- HTNWasher, Bolt Nut
- NDGWasher, Bolt, Nut, Non-Spinal, Metallic
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1792-2024 | 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 | Nail system contains an out of specification driver-socket which could result in inability to pick up nails or apply sufficient torque. | Class II | Open, Classified | |
| Z-1791-2024 | 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 | Nail system contains an out of specification driver-socket which could result in inability to pick up nails or apply sufficient torque. | Class II | Open, Classified | |
| Z-0932-2024 | 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. Intended to be used as an aid to the treatment of certain types of fractures, non-unions or osteotomies. | Plates, part of a wrist fixation system, are affixed during surgery with bearings that may pop out from distal peg holes. | Class II | Open, Classified | |
| Z-1101-2023 | RipCord Syndesmosis Button, REF: STA001K | Overly aggressive tension on the pull suture, while passing the medial button through a bone/soft tissue tunnel across the fibula and tibia, can exceed its strength causing it to break. | Class II | Open, Classified | |
| Z-0359-2020 | 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. | The WHD/WHV impactors can rust over time due to an improper manufacturing process. | Class II | Open, Classified | |
| Z-0358-2020 | TriMed Peg Guide Extender, REF PEG-XTNDR, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA. | The spring on the PEG-Extender can rust due to the type of steel used to manufacture it. | Class II | Open, Classified | |
| Z-0357-2020 | 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. | The epoxy on Apex manufactured epoxy-coated instruments can pop off. | Class II | Open, Classified | |
| Z-0356-2020 | TriMed Locking Drill Guide, 2.3mm, REF GUIDELCBS-2.3, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA. | The epoxy on Apex manufactured epoxy-coated instruments can pop off. | Class II | Open, Classified | |
| Z-0355-2020 | TriMed Countersink 1.7mm, HCS, REF HSINK-1.7, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA. | The epoxy on Apex manufactured epoxy-coated instruments can pop off. | Class II | Open, Classified | |
| Z-0118-2020 | 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 TriMed, Santa Clarita, CA. | Modifications to the specification were not appropriately qualified through the company's design control process which may result in structural integrity issues of the device. | Class II | Terminated | |
| Z-1214-2019 | 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. The HEX4.0-40 Screw is a single piece machined cortical bone screw. The HEX4.0-40 screw is employed in combination with a TriMed Ankle Bone Plate such as a Sidewinder Plate, Ankle Hook Plate, Cluster, Semi-Tubular Plate, or the Locking Plate. Use of these implants is not a substitute for normal tissue healing. The TriMed Ankle Bone Plates and Screws are designed to provide additional constraint of movement of a fractured bone and are intended only as an aid to fix the fracture in place during the healing process. | The bone screw is shorter than the intended design specification. | Class II | Terminated | |
| Z-0366-2020 | 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, which are intended to penetrate the small terminal fragment to provide additional stabilization. | The firm has become aware that the angled-hole of certain semi-tubular design bone plates may have been modified from its specification, and the modification may not have been fully qualified. | Class II | Terminated | |
| Z-2877-2018 | 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 Plate is intended for use in osteotomy procedures of the ulna. | Two instrument holes located on the side of the plate, which act to align the saw guide are located on the wrong side of the plate | Class II | Terminated | |
| Z-2265-2018 | 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 | During a retrospective review of sterilization records, TriMed has determined that evidence of quarterly dose audits/verification required to comply with the regulations could not be found. Sterilization records indicate that all lots of staples were irradiated to at least the defined dose. There is a risk that this issue could result in patient infection if not properly sterilized. | Class II | Terminated | |
| Z-2264-2018 | 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 | During a retrospective review of sterilization records, TriMed has determined that evidence of quarterly dose audits/verification required to comply with the regulations could not be found. Sterilization records indicate that all lots of staples were irradiated to at least the defined dose. There is a risk that this issue could result in patient infection if not properly sterilized. | Class II | Terminated | |
| Z-2263-2018 | Nitinol Staple, Elastic Staple Large-Symmetrical, Sterile R, Model #: a) ES-18x14; b) ES-20x20; c) ES-25x22 | During a retrospective review of sterilization records, TriMed has determined that evidence of quarterly dose audits/verification required to comply with the regulations could not be found. Sterilization records indicate that all lots of staples were irradiated to at least the defined dose. There is a risk that this issue could result in patient infection if not properly sterilized. | Class II | Terminated | |
| Z-2262-2018 | Nitinol Staple, Elastic Staple Large-Asymmetrical, Sterile R, Model #: a) ES-18x15x17; b) ES-18x17x19 | During a retrospective review of sterilization records, TriMed has determined that evidence of quarterly dose audits/verification required to comply with the regulations could not be found. Sterilization records indicate that all lots of staples were irradiated to at least the defined dose. There is a risk that this issue could result in patient infection if not properly sterilized. | Class II | Terminated | |
| Z-1373-2018 | 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; Hex Driver Part Number HXDRIVER-3.5AO | Following the completion of sterilization cycle(s) of the impacted Hex Driver, the epoxy color band on the impacted Hex Driver can migrate down the shaft and/or potentially onto the sterilization tray or caddy. | Class II | Terminated | |
| Z-2849-2016 | 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 conformance with ASTM F138 or F139. The plate is used to fixation of long bone fractures. The TriMed Bone Plates are intended for use in the fixation of fractures to the Tibia, Fibula, Ulna, Radius and the Humerus. | TriMed is recalling the Semi-Tubular Plates with 10 holes (SMTP-10) because a non-locking screw passed through a hole in a SMTP-10 plate being implanted. | Class II | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Trimed Inc edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain