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
193–216 of 1322
Cleared Nov 15, 2022
ALPHALOK Plating System
K221558
Vilex, LLC
Orthopedic · 168d
Cleared Nov 04, 2022
Humerus & Ulna System
K213108
Auxein Medical Private Limited
Orthopedic · 406d
Cleared Oct 27, 2022
HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System
K222282
Hospital Equipment Manufacturing Company
Orthopedic · 90d
Cleared Oct 18, 2022
EVOS Wrist Spanning Plate
K213123
Smith & Nephew, Inc.
Orthopedic · 386d
Cleared Oct 03, 2022
Varixis Elbow System
K213014
Auxein Medical Private Limited
Orthopedic · 378d
Cleared Oct 03, 2022
Arthrex 2.4 mm Volar Distal Radius Plate System
K222267
Arthrex, Inc.
Orthopedic · 67d
Cleared Sep 30, 2022
Arthrex 3.5 mm Locking Compression Plates
K222244
Arthrex, Inc.
Orthopedic · 66d
Cleared Sep 27, 2022
Medline UNITE® Medial Malleolus Peg Plate System
K221360
Medline Industries, LP
Orthopedic · 139d
Cleared Sep 20, 2022
DePuy Synthes 3.5mm Intrapelvic Acetabular System
K221809
DePuy Synthes
Orthopedic · 90d
Cleared Sep 02, 2022
Bonebridge Osteosynthesis Plating System
K213864
Bonebridge AG
Orthopedic · 266d
Cleared Aug 31, 2022
I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)
K210935
I.T.S. GmbH
Orthopedic · 520d
Cleared Aug 24, 2022
ARIX Small Fragment System
K221920
Jeil Medical Corporation
Orthopedic · 54d
Cleared Aug 19, 2022
Baby Gorilla®/Gorilla® Plating System
K222194
Paragon 28, Inc.
Orthopedic · 28d
Cleared Jul 08, 2022
Stryker VariAx 2 MIS Calcaneus
K221346
Stryker GmbH
Orthopedic · 60d
Cleared Jul 01, 2022
Footmotion Plating System
K221395
Newclip Technics
Orthopedic · 49d
Cleared Jun 29, 2022
Arthrex Mini Fragment System
K220937
Arthrex, Inc.
Orthopedic · 90d
Cleared Jun 17, 2022
Baby Gorilla/Gorilla Plating System
K221465
Paragon 28, Inc.
Orthopedic · 29d
Cleared Jun 10, 2022
Omni Foot and Ankle Plating System
K221362
Exremity Medical, LLC
Orthopedic · 30d
Cleared May 27, 2022
CoLink PCR Plating System
K213698
In2bones USA, LLC
Orthopedic · 185d
Cleared May 20, 2022
CalcShift™ Displacement Calcaneal Osteotomy System
K212979
Nextremity Solutions, Inc.
Orthopedic · 245d
Cleared May 18, 2022
Osteotomy Truss System (OTS)
K220463
4Web Medical, Inc.
Orthopedic · 90d
Cleared May 17, 2022
SternaLock Sternal Closure System
K212782
Biomet Microfixation
Orthopedic · 258d
Cleared May 02, 2022
ALPHALOK™ Plating System
K212348
Vilex, LLC
Orthopedic · 278d
Cleared May 02, 2022
Arthrx Fracture Plates
K213837
Arthrex, Inc.
Orthopedic · 144d