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 Synthes (Usa), Wrightmedicaltechnologyinc and Arthrex, Inc..

1322
Total
1322
Cleared
116d
Avg days
1976
Since
1322 devices
49–72 of 1322
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
Cleared Jul 25, 2025
A.L.P.S. Proximal Humerus Plating System
K251620
Zimmer Biomet
Orthopedic · 59d
Cleared Jul 18, 2025
Baby Gorilla®/Gorilla® Plating System
K250952
Paragon 28, Inc.
Orthopedic · 112d
Cleared Jul 14, 2025
The Acumed Wrist Fixation System - Plates
K251132
Acumed, LLC
Orthopedic · 94d
Cleared Jul 10, 2025
TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)
K251945
TriMed, Inc.
Orthopedic · 15d
Cleared Jun 27, 2025
Genostis Osteosynthesis System
K242988
Genostis AF
Orthopedic · 274d
Cleared Jun 26, 2025
Equinoxe® Scapula Fracture System
K243275
Exactech, Inc.
Orthopedic · 253d
Cleared Jun 26, 2025
TriMed Ulnar Osteotomy System (Ulnar Osteotomy Compression Plate)
K250929
TriMed, Inc.
Orthopedic · 90d
Cleared Jun 18, 2025
The Acumed Wrist Fixation System
K251296
Acumed, LLC
Orthopedic · 54d
Cleared Jun 11, 2025
LORRAINE 2.5/3.5mm Distal Humerus System
K250933
Bonebridge AG
Orthopedic · 75d