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..

1333
Total
1333
Cleared
115d
Avg days
1976
Since
1333 devices
25–48 of 1333
Cleared May 29, 2026
Xpert PFP
K261038
Newclip Technics
Orthopedic · 60d
Cleared May 09, 2026
Avanti Distal Elbow ORIF System
K261145
Avanti Orthopaedics, LLC
Orthopedic · 32d
Cleared Apr 30, 2026
OrthoPediatrics® Locking Cannulated Blade Plate System
K260323
OrthoPediatrics Corp.
Orthopedic · 90d
Cleared Apr 24, 2026
I.T.S. PRS Phoenix II
K260054
I.T.S. GmbH
Orthopedic · 106d
Cleared Apr 24, 2026
POYA 3.5mm Medial Proximal Tibia System
K260228
Bonebridge AG
Orthopedic · 88d
Cleared Apr 24, 2026
PC Fix System
K260411
Chest Wall Innovations, Inc.
Orthopedic · 74d
Cleared Apr 10, 2026
SMART Osteotomy System
K260090
Actis Medical Pty., Ltd.
Orthopedic · 88d
Cleared Apr 01, 2026
enHAnce PEEK Bunion System
K253718
Nvision Biomedical Technologies, Inc.
Orthopedic · 128d
Cleared Mar 25, 2026
Airlock® Ankle Plating System
K260274
Novastep SAS
Orthopedic · 55d
Cleared Mar 25, 2026
Vortex5 Tailor's Bunion Correction System
K260291
Nvision Biomedical Technologies, Inc.
Orthopedic · 55d
Cleared Mar 24, 2026
LOQTEQ® VA Proximal Humerus Plate 3.5
K254253
Aap Implantate AG
Orthopedic · 85d
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