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
385–408 of 1322
Cleared Oct 10, 2018
Geminus Volar Distal Radius Plate System
K182492
Skeletal Dynamics, LLC
Orthopedic · 29d
Cleared Oct 05, 2018
ORTHOLOC SPS Shoulder Plating System
K181587
Tornier, Inc.
Orthopedic · 112d
Cleared Oct 04, 2018
WishBone Medical Plate and Screw System
K180736
Wishbone Medical, Inc.
Orthopedic · 196d
Cleared Oct 03, 2018
ARIX Clavicle System
K180972
Jeil Medical Corporation
Orthopedic · 173d
Cleared Sep 27, 2018
CoLink View Plating System
K182402
In2bones USA, LLC
Orthopedic · 23d
Cleared Sep 18, 2018
Tandry Locking Plate System
K171904
Microware Precision Co., Ltd.
Orthopedic · 449d
Cleared Aug 24, 2018
APTUS CMC-I Fusion Plate System
K181009
Medartis AG
Orthopedic · 129d
Cleared Aug 24, 2018
AOS Small Fragment Plating System Lite
K181035
Advanced Orthopaedic Solutions, Inc. (Aos)
Orthopedic · 128d
Cleared Aug 09, 2018
EVOS Wrist Fracture Plating System
K181533
Smith & Nephew, Inc.
Orthopedic · 59d
Cleared Aug 05, 2018
APTUS® Proximal Humerus System
K181425
Medartis AG
Orthopedic · 66d
Cleared Aug 02, 2018
PL8 Wrist Reconstruction Plate
K180150
Citieffe S.R.L.
Orthopedic · 195d
Cleared Jun 15, 2018
CoLink™ Afx Plating System
K181113
In2bones USA, LLC
Orthopedic · 49d
Cleared May 23, 2018
AlignX Ankle Fusion System
K181067
Extremity Medical, LLC
Orthopedic · 30d
Cleared May 22, 2018
Omni Foot Plating System
K180808
Extremity Medical, LLC
Orthopedic · 55d
Cleared May 16, 2018
Additive Orthopaedics Patient Specific 3D Printed Bone Segments
K180239
Additive Orthopaedics, LLC
Orthopedic · 107d
Cleared May 08, 2018
Trident Extremity Fixation System
K171690
Trident Orthopedics
Orthopedic · 335d
Cleared Apr 06, 2018
A. L. P. S. Clavicle Plating System
K173767
Biomet, Inc.
Orthopedic · 116d
Cleared Mar 29, 2018
IXOS Radius Plate System
K171624
Stuckenbrock Medizintechnik GmbH
Orthopedic · 300d
Cleared Mar 19, 2018
Anchorage Bone Plating System
K172148
Stryker GmbH
Orthopedic · 245d
Cleared Mar 19, 2018
PYTHON Plate Trial Instruments
K173930
Treace Medical Concepts, Inc.
Orthopedic · 83d
Cleared Mar 15, 2018
TDM Plate and Screw System
K171808
Tdm Co., Ltd.
Orthopedic · 269d
Cleared Mar 08, 2018
ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS Humerus and Olecranon Plates & MBOSS/FIXION Screws, ARMAR / ARTIS Tibia and Buttress Plates & MBOSS/FIXION Screws, ARMAR / ARTIS 2.4mm Plates & MBOSS/FIXION Screws, ARMAR/ ARTISClavical Hook Plate & MBOSS/FIXION Screws, ARMAR/ ARTIS Metaphyseal Plate & MBOSS/FIXION Screws, ARMAR / ARTISCalcaneal Plate & MBOSS/FIXION Screws
K171320
Meril Healthcare Pvt. , Ltd.
Orthopedic · 308d
Cleared Feb 27, 2018
Activmotion Range
K173746
Newclip Technics
Orthopedic · 81d
Cleared Feb 22, 2018
Osteotomy Truss System (OTS)
K172294
4Web, Inc.
Orthopedic · 206d