510(k) Report

FDA applicant

TriMed, Inc.

Santa Clarita, CA38 decisions2005–202612 recalls

FDA records 38 decisions for TriMed, Inc. (Santa Clarita, CA) from 2005 to 2026: 38 510(k) clearances. Most are in product codes HRS (Plate, Fixation, Bone) and HWC (Screw, Fixation, Bone). Since 2016 its 510(k)s took a median of 69 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 86 predicates, 28 of them its own earlier devices. 12 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided TriMed, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

10in 2025

2007: 12008: 12009: 12010: 22011: 32012: 12016: 12019: 12020: 12021: 12022: 22023: 22024: 42025: 102026 (partial year): 4
2007high 10 (2025) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

2in 2024

2016: 12018: 72022: 12023: 12024: 2
2007high 7 (2018) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — TriMed, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like TriMed, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • HRSPlate, Fixation, Bone25decisions
  • HWCScrew, Fixation, Bone7decisions
  • HTNWasher, Bolt Nut2decisions
  • MBIFastener, Fixation, Nondegradable, Soft Tissue1decision
  • JDRStaple, Fixation, Bone1decision
  • NDKSystem, External Fixator (With Metallic Invasive Components)1decision

Also: MQV (1).

How long do its 510(k) reviews take?

Since 2016, its 26 510(k)s took a median of 69 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 90 days; 17 of its 26 were faster than that.

Whose devices does it build on?

Its devices cite 86 predicates; 28 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 43 times; 28 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K060041Trimed Bone PlatesTriMed, Inc. · 20069cite it
  • K050681Omnitech System & Easy Lock Osteosystem with Xtremities PlatesTriMed, Inc. · 20058cite it
  • K043263Trimed Osteotomy PlateTriMed, Inc. · 20055cite it
  • K222637TriMed Wrist Fixation System 3TriMed, Inc. · 20223cite it
  • K112794Eos Small Bone Fixation SystemTriMed, Inc. · 20122cite it
  • K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc. · 20212cite it

What has FDA decided for it lately?

  • K262344Large Compression ScrewsTriMed, Inc. · 2026
  • K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed…TriMed, Inc. · 2026
  • K261241TriMed Compression ScrewsTriMed, Inc. · 2026
  • K254002TriMed Volar Bearing Plates (VBEAL-13-7S); TriMed Volar Bearing Plates (VBEAR-13-7S); TriMed Volar Bearing…TriMed, Inc. · 2026
  • K252061Distal Xtremities SystemTriMed, Inc. · 2025
  • K251134RipCordTriMed, Inc. · 2025
  • K251945TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)TriMed, Inc. · 2025
  • K250929TriMed Ulnar Osteotomy System (Ulnar Osteotomy Compression Plate); TriMed Ulnar Osteotomy System (Hex…TriMed, Inc. · 2025

All 38 as TriMed, Inc. →

What has been recalled?

12 recalls linked to its devices; the latest:

  • K234040TriMed, Threaded IM Nail 3.6mm, 60mm, TI, Ref: IMN3.6-60 T, Non Sterile, MD, Rx Only…Mar 19, 2024Class II
  • K234040TriMed, Threaded IM Nail 3.6mm, 60mm, TI, Ref: IMN3.6-60 T, Non Sterile, MD, Rx Only…Mar 19, 2024Class II
  • K222637Volar Bearing Plate. REF: VBEAL-3-7N, VBEAL-5-7N, VBEAL-3-7S, VBEAL-5-7S, VBEAL-7-7S…Nov 28, 2023Class II
  • K220650RipCord Syndesmosis Button, REF: STA001KDec 22, 2022Class II
  • K060041TriMed Hex Cortical Screw 4.0, 40 mm, REF HEX4.0-40, non-Sterile, RX, a component of the…Aug 24, 2018Class II
  • K060041TriMed Olecranon Hook Plate, Lt, 6-Holes, REF: OHOOKL-6, Non-Sterile, RX only, (01)…Aug 15, 2018Class II

Other applicant names beginning “TriMed”

FDA records each applicant name separately; these may or may not be the same firm.

Trimed Systems, Inc. 1