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 TriMed, Inc., Arthrex, Inc. and Tyber Medical, LLC.

1307
Total
1307
Cleared
116d
Avg days
1976
Since
1307 devices
145–168 of 1307
Cleared Aug 18, 2023
Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, Pangea Humerus Plating System
K231262
Stryker GmbH
Orthopedic · 109d
Cleared Aug 18, 2023
Sterile Products of the APTUS System
K232144
Medartis AG
Orthopedic · 30d
Cleared Jul 17, 2023
ARIX Ankle System
K231441
Jeil Medical Corporation
Orthopedic · 60d
Cleared Jun 02, 2023
APTUS® 3.5 TriLock Straight Plates
K230971
Medartis AG
Orthopedic · 58d
Cleared May 30, 2023
Smith & Nephew ACCORD™ Cable System
K223762
Smith & Nephew
Orthopedic · 166d
Cleared May 25, 2023
KLS Martin LINOS Wrist System
K222624
KLS-Martin L.P.
Orthopedic · 267d
Cleared May 03, 2023
ARIX Humerus System
K230938
Jeil Medical Corporation
Orthopedic · 30d
Cleared Apr 27, 2023
PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System
K222381
Stryker GmbH
Orthopedic · 265d
Cleared Apr 25, 2023
ALPHALOK Plating System
K230204
Vilex, LLC
Orthopedic · 90d
Cleared Apr 07, 2023
PRO Plating System, Stryker Trauma Pelvic Set (Matta)
K223772
Stryker GmbH
Orthopedic · 112d
Cleared Mar 30, 2023
MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion System, DynaMET™ Lesser TMT Fusion System
K223342
Crossroads Extremity Systems, LLC
Orthopedic · 149d
Cleared Mar 30, 2023
Medartis APTUS® Ulna Plates
K223853
Medartis AG
Orthopedic · 97d
Cleared Mar 29, 2023
KLS Martin Level One Rib Fixation System
K222397
KLS-Martin L.P.
Orthopedic · 233d
Cleared Mar 28, 2023
KLS Martin Pure Pectus System
K221938
KLS-Martin L.P.
Orthopedic · 270d
Cleared Mar 17, 2023
LOQTEQ® VA Elbow Plates 2.7/3.5 System
K230141
Aap Implantate AG
Orthopedic · 58d
Cleared Mar 07, 2023
Tyber Medical Anatomical Plating System
K222465
Tyber Medical, LLC
Orthopedic · 204d
Cleared Jan 25, 2023
Medline UNITE® Ankle Fusion Plating System
K222665
Medline Industries, Inc.
Orthopedic · 141d
Cleared Jan 05, 2023
Treace Medical Concepts (TMC) Plating System
K221181
Treace Medical Concepts, Inc.
Orthopedic · 255d
Cleared Dec 21, 2022
TriMed Wrist Fixation System 3
K222637
TriMed, Inc.
Orthopedic · 112d
Cleared Nov 22, 2022
ARIX Rib System
K221412
Jeil Medical Corporation
Orthopedic · 190d
Cleared Oct 18, 2022
EVOS Wrist Spanning Plate
K213123
Smith & Nephew, Inc.
Orthopedic · 386d
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