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
145–168 of 1311
Cleared Dec 13, 2023
Anatomical Plating System (various)
K232652
Tyber Medical, LLC
Orthopedic · 104d
Cleared Dec 08, 2023
Valkyrie Thoracic Fixation System
K232515
Jm Longyear Manufacturing, LLC D.B.A. Able Medical Devices
Orthopedic · 112d
Cleared Dec 04, 2023
Tyber Medical Distal Radius Plating System
K232693
Tyber Medical, LLC
Orthopedic · 90d
Cleared Sep 29, 2023
TriLEAP Plating System
K230591
Crossroads Extremity Systems
Orthopedic · 210d
Cleared Sep 25, 2023
Exactech Equinoxe PHx Fracture System
K223933
Exactech, Inc.
Orthopedic · 269d
Cleared Sep 01, 2023
KITE Distal Fibula Kit
K230623
Intrauma S.P.A
Orthopedic · 179d
Cleared Sep 01, 2023
TriMed Clavicle Fixation System
K230805
TriMed, Inc.
Orthopedic · 162d
Cleared Aug 28, 2023
Distal Elbow Plating System
K231623
Skeletal Dynamics, Inc.
Orthopedic · 87d
Cleared Aug 24, 2023
APS Metal Plate & Screw System
K223150
A Plus Biotechnology Co., Ltd.
Orthopedic · 323d
Cleared Aug 18, 2023
Pangea Utility Plating System, Pangea Platform
K231257
Stryker GmbH
Orthopedic · 109d
Cleared Aug 18, 2023
Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, Pangea Humerus Plating System
K231262
Stryker GmbH
Orthopedic · 109d
Cleared Aug 18, 2023
Sterile Products of the APTUS System
K232144
Medartis AG
Orthopedic · 30d
Cleared Aug 17, 2023
Tandry Locking Plate System
K230690
Microware Precision Co., Ltd.
Orthopedic · 157d
Cleared Jul 19, 2023
TAMINA 3.5mm Proximal Humerus System
K231292
Bonebridge AG
Orthopedic · 76d
Cleared Jul 17, 2023
ARIX Ankle System
K231441
Jeil Medical Corporation
Orthopedic · 60d
Cleared Jun 02, 2023
APTUS® 3.5 TriLock Straight Plates
K230971
Medartis AG
Orthopedic · 58d
Cleared May 30, 2023
Smith & Nephew ACCORD™ Cable System
K223762
Smith & Nephew
Orthopedic · 166d
Cleared May 25, 2023
KLS Martin LINOS Wrist System
K222624
KLS-Martin L.P.
Orthopedic · 267d
Cleared May 03, 2023
ARIX Humerus System
K230938
Jeil Medical Corporation
Orthopedic · 30d
Cleared Apr 27, 2023
PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System
K222381
Stryker GmbH
Orthopedic · 265d
Cleared Apr 25, 2023
ALPHALOK Plating System
K230204
Vilex, LLC
Orthopedic · 90d
Cleared Apr 07, 2023
PRO Plating System, Stryker Trauma Pelvic Set (Matta)
K223772
Stryker GmbH
Orthopedic · 112d
Cleared Mar 30, 2023
MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion System, DynaMET™ Lesser TMT Fusion System
K223342
Crossroads Extremity Systems, LLC
Orthopedic · 149d
Cleared Mar 30, 2023
Medartis APTUS® Ulna Plates
K223853
Medartis AG
Orthopedic · 97d