Chrysalis Intelligence · Sponsors · TriMed, Inc.

TriMed, Inc.

Santa Clarita, CA, US · 24 510(k) clearances · 4 recalls

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Total clearances
24
2020-01-05 → 2026-08-12
Last 12 months
4
Product codes
3
Most recent
2026-08-12
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
HRS Plate, Fixation, Bone Class II Orthopedic 16 2026-07-16
HWC Screw, Fixation, Bone Class II Orthopedic 6 2026-08-12
HTN Washer, Bolt Nut Class II Orthopedic 2 2025-07-11
Safety

Recalls (4)

Class I (serious)
0
Risk of injury / death
Total recalls
4
Currently ongoing
4
Most recent
2024-03-19
DateSeverityStatusRecall # ProductCodeReason
2024-03-19 Class II Ongoing 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, 65… — Nail system contains an out of specification driver-socket which could result in inability to pick up nails or apply sufficient torque.
2024-03-19 Class II Ongoing 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, 65… — Nail system contains an out of specification driver-socket which could result in inability to pick up nails or apply sufficient torque.
2023-11-28 Class II Ongoing 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-… — Plates, part of a wrist fixation system, are affixed during surgery with bearings that may pop out from distal peg holes.
2022-12-22 Class II Ongoing 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 stre…
Filings

All 510(k) clearances (24)

Date K-number Device Code Class Specialty
2026-08-12 K262344 Large Compression Screws HWC Class II Orthopedic
2026-07-16 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 Class II Orthopedic
2026-05-14 K261241 TriMed Compression Screws HWC Class II Orthopedic
2026-01-15 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 Class II Orthopedic
2025-08-20 K252061 Distal Xtremities System HRS Class II Orthopedic
2025-07-11 K251134 RipCord HTN Class II Orthopedic
2025-07-10 K251945 TriMed Total Wrist Fusion System (Total Wrist Fusion Plate) HRS Class II Orthopedic
2025-06-26 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 Class II Orthopedic
2025-05-22 K250935 TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal System (Fifth Metatarsal Screw) HRS Class II Orthopedic
2025-04-10 K243943 TriMed® Compression Screws HWC Class II Orthopedic
2025-04-08 K250948 TriMed Fusion Cup System HRS Class II Orthopedic
2025-03-19 K243999 TriMed Ankle Fixation System HRS Class II Orthopedic
2025-03-19 K243987 TriMed Elbow and Forearm System HRS Class II Orthopedic
2025-01-15 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 Class II Orthopedic
2024-11-26 K243050 TriMed Posterior Malleolus Fixation System HRS Class II Orthopedic
2024-09-17 K241942 TriMed Bridge Plates HRS Class II Orthopedic
2024-04-17 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 Class II Orthopedic
2024-01-18 K234040 TriMed Threaded Intramedullary Nail System HWC Class II Orthopedic
2023-09-01 K230805 TriMed Clavicle Fixation System HRS Class II Orthopedic
2023-04-17 K230749 TriMed Threaded Intramedullary Nail System HWC Class II Orthopedic
2022-12-21 K222637 TriMed Wrist Fixation System 3 HRS Class II Orthopedic
2022-06-01 K220650 TriMed Ripcord Device HTN Class II Orthopedic
2021-08-06 K211783 TriMed Threaded Intramedullary Nail System HWC Class II Orthopedic
2020-01-05 K192696 TriMed ASET Foot Plating System HRS Class II Orthopedic
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence