HRS · Class II · 21 CFR 888.3030

FDA Product Code HRS: Plate, Fixation, Bone

FDA product code HRS covers bone fixation plates.

These implants stabilize fractures and osteotomies by bridging and compressing bone segments during healing. They are used across skeletal sites including the hand, wrist, foot, and ankle.

HRS devices are Class II medical devices, regulated under 21 CFR 888.3030 and reviewed by the FDA Orthopedic panel.

Leading manufacturers include TriMed, Inc., Arthrex, Inc. and Tyber Medical, LLC.

1307
Total
1307
Cleared
116d
Avg days
1976
Since
1307 devices
25–48 of 1307
Cleared Jan 15, 2026
TriMed Volar Bearing Plates (VBEAL-13-7S)
K254002
TriMed, Inc.
Orthopedic · 31d
Cleared Jan 12, 2026
Arthrex Anatomic Lapidus Plates and I-Beam Lapidus Plates
K252807
Arthrex, Inc.
Orthopedic · 131d
Cleared Jan 06, 2026
TRILEAP Plating System
K253178
Crossroads Extremity Systems
Orthopedic · 102d
Cleared Dec 19, 2025
Pectus Versa System
K251050
Gm Dos Reis Industria E Comercio
Orthopedic · 260d
Cleared Dec 17, 2025
BRUSIO Trauma Toolbox System
K252191
Bonebridge AG
Orthopedic · 156d
Cleared Dec 11, 2025
KLS Martin Pure Pectus System
K250988
KLS-Martin L.P.
Orthopedic · 255d
Cleared Dec 11, 2025
APS Osteotomy Fixation System (0945-1302-xx /4.5mm Cortex Screw)
K252897
A Plus Biotechnology Co., Ltd.
Orthopedic · 91d
Cleared Dec 11, 2025
HyperFlex® Bunion Correction System
K252997
Hyperflex Medical
Orthopedic · 84d
Cleared Nov 19, 2025
SternaFuse Ti Fixation System
K252661
Fusion Innovations, LLC
Orthopedic · 89d
Cleared Nov 18, 2025
ToeJack MIS Bunion System
K253423
Nvision Biomedical Technologies, Inc.
Orthopedic · 54d
Cleared Nov 14, 2025
KLS Martin IPS Forearm System
K250865
KLS-Martin L.P.
Orthopedic · 238d
Cleared Nov 13, 2025
Geminus Volar Distal Radius Plating System
K252949
Skeletal Dynamics, Inc.
Orthopedic · 58d
Cleared Nov 12, 2025
WRISTAR MultiAx Distal Radius Kit
K252959
Intrauma S.P.A
Orthopedic · 57d
Cleared Oct 28, 2025
Fine Osteotomy™
K253300
Bodycad Laboratories, Inc.
Orthopedic · 29d
Cleared Oct 09, 2025
Pediatric Plating Platform I Small-Mini
K252600
OrthoPediatrics Corp.
Orthopedic · 52d
Cleared Sep 08, 2025
MAXXOS P.A.C.E. Foot & Ankle Plating System
K251892
Maxxos Medical GmbH
Orthopedic · 80d
Cleared Aug 21, 2025
Fine Osteotomy™
K250923
Bodycad Laboratories, Inc.
Orthopedic · 147d
Cleared Aug 21, 2025
Treace Medical Concepts (TMC) Implant Fixation System
K251135
Treace Medical Concepts
Orthopedic · 129d
Cleared Aug 21, 2025
The Acumed Wrist Fixation System - 2.4mm Screws
K252356
Acumed, LLC
Orthopedic · 23d
Cleared Aug 20, 2025
Distal Xtremities System
K252061
TriMed, Inc.
Orthopedic · 50d
Cleared Aug 18, 2025
ANTHEM® Fracture System
K251161
Globus Medical, Inc.
Orthopedic · 125d
Cleared Aug 16, 2025
OsteoCentric® UnifiMI® TCS Plating System
K251913
OsteoCentric Technologies
Orthopedic · 54d
Cleared Aug 15, 2025
KLS Martin Ixos System
K250620
KLS-Martin L.P.
Orthopedic · 168d
Cleared Jul 30, 2025
Tyber Medical Distal Radius Plating System
K251361
Tyber Medical, LLC
Orthopedic · 90d