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
73–96 of 1322
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
Cleared Mar 19, 2025
TriMed Elbow and Forearm System
K243987
TriMed, Inc.
Orthopedic · 86d
Cleared Mar 19, 2025
TriMed Ankle Fixation System
K243999
TriMed, Inc.
Orthopedic · 83d
Cleared Mar 18, 2025
The OsteoCentric Bone Plate and Screw System
K250494
OsteoCentric Technologies
Orthopedic · 26d
Cleared Mar 17, 2025
BPS Wrist Fracture System
K250498
Orthonovis, Inc.
Orthopedic · 25d
Cleared Mar 07, 2025
APTUS Hand System
K243610
Medartis AG
Orthopedic · 105d
Cleared Feb 27, 2025
CastleLoc Pectus Bar System
K243357
L & K Biomed Co., Ltd.
Orthopedic · 121d
Cleared Feb 19, 2025
EVOS Pelvic and Acetabular System
K241666
Smith & Nephew
Orthopedic · 254d
Cleared Feb 19, 2025
A.L.P.S. Small Fragment Plating System
K243761
Biomet Orthopedics
Orthopedic · 75d
Cleared Feb 10, 2025
Locking Plates and Screws Systems
K240958
Hebei Ruihe Medical Devices Co., Ltd.
Orthopedic · 308d
Cleared Feb 06, 2025
Signature Osteosynthesis Plate System
K241599
Signature Orthopaedic Pty , Ltd.
Orthopedic · 247d
Cleared Feb 06, 2025
BPS - Bone Fragment Fixation Plates, Screws and Washers
K250055
Orthonovis, Inc.
Orthopedic · 27d
Cleared Jan 29, 2025
Versalock Upper Limb Plating System
K243740
GM Dos Reis Industria e Comercio Ltda.
Orthopedic · 56d
Cleared Jan 15, 2025
TriMed Wrist Fixation System (Volar Bearing Plates)
K243569
TriMed, Inc.
Orthopedic · 58d