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
241–264 of 1311
Cleared Jul 27, 2021
Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot System,Integra CAPTURE Screw System & Integra Ti6 Internal Fixation System,Subtalar MBA System,MetaSurg Subtalar Implant,NewDeal BOLD Screw,NewDeal HALLU Lock Plate System,NewDeal HALLU Plates,QWIX Positioning Screw,SPIN Snap-Off Screw,NewDeal TIBIAXYS System
K210016
Integra LifeSciences Corporation
Orthopedic · 204d
Cleared Jul 16, 2021
Avanti Orthopaedics Ulnar Shortening System
K211592
Avanti Orthopaedics, Inc.
Orthopedic · 53d
Cleared Jul 15, 2021
Acumed Clavicle Hook Plating System
K210750
Acumed, LLC
Orthopedic · 125d
Cleared Jul 09, 2021
TRUEMED HAND, FOOT AND ANKLE PLATES SYSTEM
K200575
Truemed Group, LLC
Orthopedic · 491d
Cleared Jun 29, 2021
Smith & Nephew Plates and Screws
K210837
Smith & Nephew, Inc.
Orthopedic · 99d
Cleared Jun 23, 2021
Valkyrie Thoracic Fixation System
K211695
Jm Longyear Manufacturing, LLC D.B.A. Able Medical Devices
Orthopedic · 21d
Cleared Jun 02, 2021
DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System)
K211051
DePuy Synthes
Orthopedic · 55d
Cleared May 06, 2021
DRPx Locking Distal Radius Plate System
K202971
Orthopaedic Implant Company
Orthopedic · 218d
Cleared Apr 30, 2021
JACE Medical Thoracic Plating System
K210290
Jace Medical, LLC
Orthopedic · 87d
Cleared Apr 20, 2021
SOLE Medial Column Fusion Plate
K210157
Orthofix Srl
Orthopedic · 89d
Cleared Apr 13, 2021
Volition Plating System
K210658
Ortho Solutions UK , Ltd.
Orthopedic · 40d
Cleared Apr 08, 2021
DePuy Synthes Variable Angle Locking Patella Plating System
K210408
Synthes USA Products, LLC
Orthopedic · 56d
Cleared Mar 26, 2021
DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System
K210205
Synthes USA Products, LLC
Orthopedic · 59d
Cleared Mar 26, 2021
GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System
K210534
Gramercy Extremity Orthopedics, LLC
Orthopedic · 30d
Cleared Mar 25, 2021
Arthrex Patella SuturePlates
K203834
Arthrex, Inc.
Orthopedic · 85d
Cleared Mar 12, 2021
CoLink Mfx Implant System
K210060
In2bones USA, LLC
Orthopedic · 60d
Cleared Mar 08, 2021
Versalock Periprosthetic Femur Plates System-GMReis
K201728
GM Dos Reis Industria e Comercio Ltda.
Orthopedic · 258d
Cleared Mar 03, 2021
LOQTEQ Distal Lateral Femur Plate 4.5 System
K210043
Aap Implantate AG
Orthopedic · 55d
Cleared Mar 02, 2021
Able Medical Devices Valkyrie Thoracic Fixation System
K202889
Jm Longyear Manufacturing, LLC D.B.A. Able Medical Devices
Orthopedic · 155d
Cleared Feb 24, 2021
ExtremiLOCK Lateral Ankle Fusion Plates
K203479
Osteomed
Orthopedic · 89d
Cleared Feb 22, 2021
Foot and Ankle System
K200062
Leith Medical, LLC
Orthopedic · 406d
Cleared Feb 19, 2021
A.L.P.S. Clavicle Plating System
K210192
Biomet, Inc.
Orthopedic · 25d
Cleared Feb 03, 2021
Arthrex Pilon Fusion System
K203294
Arthrex, Inc.
Orthopedic · 86d
Cleared Jan 28, 2021
Biomet Microfixation RibFix Advantage System
K203474
Biomet Micofixation
Orthopedic · 64d