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
289–312 of 1322
Cleared Oct 08, 2020
Piccolo Composite Proximal Tibia Plate System
K201917
CarboFix Orthopedics , Ltd.
Orthopedic · 90d
Cleared Sep 15, 2020
ARIX Elbow System
K201656
Jeil Medical Corporation
Orthopedic · 89d
Cleared Sep 11, 2020
DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System
K201959
DePuy Synthes
Orthopedic · 59d
Cleared Sep 09, 2020
DePuy Synthes Variable Angle Locking Patella Plating System
K201578
Synthes USA Products, LLC
Orthopedic · 90d
Cleared Sep 02, 2020
Arthrex Mesh Plates
K201677
Arthrex, Inc.
Orthopedic · 75d
Cleared Jul 27, 2020
Stratum™ Reduced Size Foot Plating System
K200785
Nextremity Solutions, Inc.
Orthopedic · 123d
Cleared Jul 27, 2020
Arthrex Compression Screws
K201132
Arthrex, Inc.
Orthopedic · 90d
Cleared Jul 24, 2020
DePuy Synthes 2.7mm VA LCP Clavicle Plate System
K201321
DePuy Synthes
Orthopedic · 67d
Cleared Jul 22, 2020
DAC Dynamic Active Compression Plate
K200513
Pioneer Surgical Technology, Inc., Dba Rti Surgical
Orthopedic · 142d
Cleared Jul 22, 2020
EVOS Straight Proximal Humerus 7-15 hole Plates (137-225mm)
K201527
Smith & Nephew, Inc.
Orthopedic · 44d
Cleared Jul 15, 2020
CoLink Plating System
K201149
In2bones USA, LLC
Orthopedic · 77d
Cleared Jul 08, 2020
Arthrex DynaNite Compression Plate
K193345
Arthrex, Inc.
Orthopedic · 218d
Cleared Jul 06, 2020
Arthrex MaxForce MTP Compression Plates and Screws
K201235
Arthrex, Inc.
Orthopedic · 60d
Cleared Jun 25, 2020
Lever Action Plate System
K200834
Mcginley Orthpaedic Innovations, LLC
Orthopedic · 87d
Cleared Jun 05, 2020
AxSOS 3 AF System and AxSOS 3 Ti System
K200398
Stryker GmbH
Orthopedic · 108d
Cleared Jun 01, 2020
Skeletal Dynamics Forearm Plating System
K200538
Skeletal Dynamics, Inc.
Orthopedic · 90d
Cleared May 22, 2020
JPS JuniOrtho Plating System
K200246
Orthofix Srl
Orthopedic · 112d
Cleared May 14, 2020
Distal Humerus Plating System
K200367
Skeletal Dynamics, Inc.
Orthopedic · 90d
Cleared May 14, 2020
Skeletal Dynamics Midshaft Humerus Plating System
K200701
Skeletal Dynamics, Inc.
Orthopedic · 57d
Cleared May 08, 2020
Treace Medical Concepts (TMC) Plating System
K200961
Treace Medical Concepts, Inc.
Orthopedic · 28d
Cleared Apr 23, 2020
CoLink Cfx Plating System
K200762
In2bones USA, LLC
Orthopedic · 30d
Cleared Apr 09, 2020
ATLAS Plating System
K191867
MiRus, LLC
Orthopedic · 272d
Cleared Mar 26, 2020
APTUS® Ankle Trauma System 2.8/3.5
K193633
Medartis AG
Orthopedic · 90d
Cleared Mar 26, 2020
APTUS® Foot 2.8-3.5 System
K193639
Medartis AG
Orthopedic · 90d