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..

1319
Total
1319
Cleared
116d
Avg days
1976
Since
1319 devices
385–408 of 1319
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
Cleared Jan 16, 2018
Activ Ankle
K173641
Newclip Technics
Orthopedic · 53d
Cleared Jan 08, 2018
EVOS Small Fragment Upper Extremity Plates
K173293
Smith & Nephew, Inc.
Orthopedic · 84d
Cleared Jan 04, 2018
Alians Elbow Locking Plating System
K171372
Newclip Technics
Orthopedic · 239d
Cleared Dec 21, 2017
Life Spine Foot and Ankle Plating System
K172973
Life Spine, Inc.
Orthopedic · 86d
Cleared Dec 15, 2017
AxSOS 3 Ti
K172350
Stryker GmbH
Orthopedic · 134d
Cleared Dec 01, 2017
ARIX Humerus System
K172008
Jeil Medical Corporation
Orthopedic · 151d
Cleared Nov 13, 2017
ANTHEM Fracture System
K173166
Globus Medical, Inc.
Orthopedic · 45d
Cleared Sep 21, 2017
ARIX Wrist System
K170705
Jeil Medical Corporation
Orthopedic · 197d
Cleared Sep 21, 2017
DARCO Locking Bone Plate System
K171852
Wrightmedicaltechnologyinc
Orthopedic · 92d
Cleared Sep 08, 2017
APTUS(R) Wrist 2.5 System
K172170
Medartis AG
Orthopedic · 52d