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..

1311
Total
1311
Cleared
116d
Avg days
1976
Since
1311 devices
49–72 of 1311
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
Cleared Jun 04, 2025
Montblanc Plate System
K243368
Medifield Medical Co., Ltd.
Orthopedic · 217d
Cleared May 30, 2025
ARIX Pectus Bar System
K242751
Jeil Medical Corporation
Orthopedic · 260d
Cleared May 29, 2025
SIGNEX
K243469
Osteonic Co., Ltd.
Orthopedic · 202d
Cleared May 22, 2025
TriMed Fifth Metatarsal System (Fifth Metatarsal Plate)
K250935
TriMed, Inc.
Orthopedic · 55d
Cleared Apr 29, 2025
Pediatric Plating Platform Hip
K243963
OrthoPediatrics Corp.
Orthopedic · 127d
Cleared Apr 25, 2025
CastleLoc Pectus Bar System
K250892
L & K Biomed Co., Ltd.
Orthopedic · 31d
Cleared Apr 24, 2025
CanMINI Hand and Foot System
K242973
Canwell Medical Co., Ltd.
Orthopedic · 210d
Cleared Apr 23, 2025
Xpert Knee
K250155
Newclip Technics
Orthopedic · 92d
Cleared Apr 08, 2025
TriMed Fusion Cup System
K250948
TriMed, Inc.
Orthopedic · 18d
Cleared Mar 26, 2025
Arthrex Humeral Plating System and Cerclage Button
K243995
Arthrex, Inc.
Orthopedic · 90d
Cleared Mar 19, 2025
Tyber Medical Anatomical Plating System
K242486
Tyber Medical, LLC
Orthopedic · 210d