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
265–288 of 1311
Cleared Jan 27, 2021
EVOS Large Fragment Plating System
K203405
Smith & Nephew, Inc.
Orthopedic · 69d
Cleared Jan 08, 2021
ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating System
K201259
Wrightmedicaltechnologyinc
Orthopedic · 242d
Cleared Dec 29, 2020
Baby Gorilla/Gorilla Plating System
K203511
Paragon 28, Inc.
Orthopedic · 29d
Cleared Dec 16, 2020
DePuy Synthes 2.7mm VA LCP Clavicle Plate System, DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System
K203414
DePuy Synthes
Orthopedic · 27d
Cleared Dec 14, 2020
Javelin Tailor's Bunion Fixation System
K202657
Nvision Biomedical Technologies, Inc.
Orthopedic · 91d
Cleared Nov 24, 2020
PolyLock Plating System
K202959
Fusion Orthopedics, LLC
Orthopedic · 55d
Cleared Nov 20, 2020
Ortho Solutions Plating System
K202764
Ortho Solutions UK , Ltd.
Orthopedic · 60d
Cleared Nov 17, 2020
Activ Fuse
K202307
Newclip Technics
Orthopedic · 95d
Cleared Nov 16, 2020
EVOS Large Fragment Plating System
K201918
Smith & Nephew, Inc.
Orthopedic · 129d
Cleared Oct 29, 2020
ANTHEM Fracture System
K202496
Globus Medical, Inc.
Orthopedic · 59d
Cleared Oct 29, 2020
ARIX Ankle Distal Tibia System
K202912
Jeil Medical Corporation
Orthopedic · 30d
Cleared Oct 26, 2020
AOS Fibonacci Lower Extremity Plating System – AOS Proximal Tibia Plating System
K202489
Advanced Orthopaedic Solutions, Inc.
Orthopedic · 56d
Cleared Oct 13, 2020
Skeletal Dynamics Ulnar Shortening Plating System
K201962
Skeletal Dynamics, Inc.
Orthopedic · 90d
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