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
145–168 of 1322
Cleared Mar 21, 2024
DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment Plating System
K233665
DePuy Synthes
Orthopedic · 127d
Cleared Mar 21, 2024
APTUS Hand Scaphoid Plates
K234062
Medartis AG
Orthopedic · 90d
Cleared Feb 22, 2024
Treace Medical Systems (TMC) Plating System
K240173
Treace Medical Concepts, Inc.
Orthopedic · 30d
Cleared Jan 19, 2024
HKT Anatomical Locking Trauma System
K231213
Hankil Tech Medical Co., Ltd.
Orthopedic · 266d
Cleared Jan 18, 2024
Medline UNITE Ancillary Foot Recon Plating System
K234031
Medline Industires, LP
Orthopedic · 29d
Cleared Jan 12, 2024
Quick - Radius Disposable Set
K231684
GM Dos Reis Industria e Comercio Ltda.
Orthopedic · 217d
Cleared Dec 21, 2023
SkyOPS™ Orthopedic Plate System
K233154
Sky Surgical, LLC
Orthopedic · 85d
Cleared Dec 21, 2023
Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag System
K233423
Tyber Medical, LLC
Orthopedic · 72d
Cleared Dec 20, 2023
TM Plating System
K233017
Tyber Medical, LLC
Orthopedic · 89d
Cleared Dec 15, 2023
Internal Locking Plate and Screw Fixation System
K232394
Changzhou Geasure Medical Apparatus and Instruments Co., Ltd.
Orthopedic · 128d
Cleared Dec 14, 2023
ARIX Ankle Distal Tibia System
K231887
Jeil Medical Corporation
Orthopedic · 170d
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