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
25–48 of 1322
Cleared Mar 23, 2026
Clavicle Fixation System
K254288
Skeletal Dynamics, Inc.
Orthopedic · 82d
Cleared Mar 19, 2026
CastleLoc Pectus Bar System
K260448
L & K Biomed Co., Ltd.
Orthopedic · 36d
Cleared Mar 17, 2026
APS Spear Locking Plate
K254053
A Plus Biotechnology Co., Ltd.
Orthopedic · 90d
Cleared Mar 17, 2026
Super Upper Limbs Versalock Plating System
K260390
GM Dos Reis Industria e Comercio Ltda.
Orthopedic · 39d
Cleared Mar 16, 2026
APTUS Shoulder Proximal Humerus System, PentaLock 3.5
K253916
Medartis AG
Orthopedic · 98d
Cleared Mar 11, 2026
Xpert Hand
K253906
Newclip Technics
Orthopedic · 96d
Cleared Mar 09, 2026
DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating System
K260069
Synthes GmbH
Orthopedic · 59d
Cleared Mar 03, 2026
Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button
K260353
Arthrex, Inc.
Orthopedic · 28d
Cleared Mar 02, 2026
VOLT™ Ankle Trauma 2.7/3.5 Plating System
K254054
Synthes GmbH
Orthopedic · 75d
Cleared Feb 27, 2026
HKT Anatomical Locking Trauma System
K254249
Hankil Tech Medical Co., Ltd.
Orthopedic · 60d
Cleared Feb 26, 2026
RIB LINK™ Fixation System
K252166
Globus Medical, Inc.
Orthopedic · 231d
Cleared Feb 20, 2026
KLS Martin Pure Pectus System
K253660
KLS-Martin L.P.
Orthopedic · 92d
Cleared Feb 20, 2026
KLS Martin Ixos System
K254162
KLS-Martin L.P.
Orthopedic · 60d
Cleared Feb 12, 2026
Wrist Fracture System
K251732
Met One Technologies, LLC
Orthopedic · 251d
Cleared Jan 21, 2026
Arthrex Variable Angle (VA) Proximal Tibia Plating System
K253713
Arthrex, Inc.
Orthopedic · 58d
Cleared Jan 15, 2026
TriMed Volar Bearing Plates (VBEAL-13-7S)
K254002
TriMed, Inc.
Orthopedic · 31d
Cleared Jan 12, 2026
Arthrex Anatomic Lapidus Plates and I-Beam Lapidus Plates
K252807
Arthrex, Inc.
Orthopedic · 131d
Cleared Jan 06, 2026
TRILEAP Plating System
K253178
Crossroads Extremity Systems
Orthopedic · 102d
Cleared Dec 19, 2025
Pectus Versa System
K251050
Gm Dos Reis Industria E Comercio
Orthopedic · 260d
Cleared Dec 17, 2025
BRUSIO Trauma Toolbox System
K252191
Bonebridge AG
Orthopedic · 156d
Cleared Dec 11, 2025
KLS Martin Pure Pectus System
K250988
KLS-Martin L.P.
Orthopedic · 255d
Cleared Dec 11, 2025
APS Osteotomy Fixation System (0945-1302-xx /4.5mm Cortex Screw)
K252897
A Plus Biotechnology Co., Ltd.
Orthopedic · 91d
Cleared Dec 11, 2025
HyperFlex® Bunion Correction System
K252997
Hyperflex Medical
Orthopedic · 84d
Cleared Nov 19, 2025
SternaFuse Ti Fixation System
K252661
Fusion Innovations, LLC
Orthopedic · 89d