Cleared Traditional

Distal Xtremities System

K252061 · TriMed, Inc. · Orthopedic
Aug 2025
Decision
50d
Days
Class 2
Risk

About This 510(k) Submission

K252061 is an FDA 510(k) clearance for the Distal Xtremities System, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by TriMed, Inc. (Valencia, US). The FDA issued a Cleared decision on August 20, 2025, 50 days after receiving the submission on July 1, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K252061 FDA.gov
FDA Decision Cleared SESE
Date Received July 01, 2025
Decision Date August 20, 2025
Days to Decision 50 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HRS — Plate, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030

Similar Devices — HRS Plate, Fixation, Bone

All 1291
Xpert Hand
K253906 · Newclip Technics · Mar 2026
DePuy Synthes VOLT? Proximal Tibia 3.5 Plating System
K260069 · Synthes GmbH · Mar 2026
Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button
K260353 · Arthrex, Inc. · Mar 2026
VOLT? Ankle Trauma 2.7/3.5 Plating System; VOLT? Calcaneus 2.7 Plating System
K254054 · Synthes GmbH · Mar 2026
HKT Anatomical Locking Trauma System
K254249 · Hankil Tech Medical Co., Ltd. · Feb 2026
RIB LINK? Fixation System
K252166 · Globus Medical, Inc. · Feb 2026

More from TriMed, Inc.

View all
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)
K254002 · HRS · Jan 2026
RipCord
K251134 · HTN · Jul 2025
TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)
K251945 · HRS · Jul 2025
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)
K250929 · HRS · Jun 2025
TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal System (Fifth Metatarsal Screw)
K250935 · HRS · May 2025