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
Growing category -
118 submissions in the last 2 years
vs 79 in the prior period
Consistent review times:
106d avg (recent)
FDA 510(k) Cleared Plate, Fixation, Bone Devices (Product Code HRS)
1311 devices
Cleared
Jun 05, 2026
APTUS Clavicle System 2.8
Medartis AG
Orthopedic
88d
Cleared
Jun 02, 2026
Pectus Blu System
Biomet Microfixation
Orthopedic
68d
Cleared
May 29, 2026
Xpert PFP
Newclip Technics
Orthopedic
60d
Cleared
May 09, 2026
Avanti Distal Elbow ORIF System
Avanti Orthopaedics, LLC
Orthopedic
32d
Cleared
Apr 30, 2026
OrthoPediatrics® Locking Cannulated Blade Plate System
OrthoPediatrics Corp.
Orthopedic
90d
Cleared
Apr 24, 2026
I.T.S. PRS Phoenix II
I.T.S. GmbH
Orthopedic
106d
Cleared
Apr 24, 2026
POYA 3.5mm Medial Proximal Tibia System
Bonebridge AG
Orthopedic
88d
Cleared
Apr 24, 2026
PC Fix System
Chest Wall Innovations, Inc.
Orthopedic
74d
Cleared
Apr 10, 2026
SMART Osteotomy System
Actis Medical Pty., Ltd.
Orthopedic
88d
Cleared
Apr 01, 2026
enHAnce PEEK Bunion System
Nvision Biomedical Technologies, Inc.
Orthopedic
128d
Cleared
Mar 25, 2026
Airlock® Ankle Plating System
Novastep SAS
Orthopedic
55d
Cleared
Mar 25, 2026
Vortex5 Tailor's Bunion Correction System
Nvision Biomedical Technologies, Inc.
Orthopedic
55d
Cleared
Mar 24, 2026
LOQTEQ® VA Proximal Humerus Plate 3.5
Aap Implantate AG
Orthopedic
85d
Cleared
Mar 23, 2026
Clavicle Fixation System
Skeletal Dynamics, Inc.
Orthopedic
82d
Cleared
Mar 19, 2026
CastleLoc Pectus Bar System
L & K Biomed Co., Ltd.
Orthopedic
36d
Cleared
Mar 17, 2026
APS Spear Locking Plate
A Plus Biotechnology Co., Ltd.
Orthopedic
90d
Cleared
Mar 17, 2026
Super Upper Limbs Versalock Plating System
GM Dos Reis Industria e Comercio Ltda.
Orthopedic
39d
Cleared
Mar 16, 2026
APTUS Shoulder Proximal Humerus System, PentaLock 3.5
Medartis AG
Orthopedic
98d
Cleared
Mar 11, 2026
Xpert Hand
Newclip Technics
Orthopedic
96d
Cleared
Mar 09, 2026
DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating System
Synthes GmbH
Orthopedic
59d
Cleared
Mar 03, 2026
Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button
Arthrex, Inc.
Orthopedic
28d
Cleared
Mar 02, 2026
VOLT™ Ankle Trauma 2.7/3.5 Plating System
Synthes GmbH
Orthopedic
75d
Cleared
Feb 27, 2026
HKT Anatomical Locking Trauma System
Hankil Tech Medical Co., Ltd.
Orthopedic
60d
Cleared
Feb 26, 2026
RIB LINK™ Fixation System
Globus Medical, Inc.
Orthopedic
231d
About Product Code HRS - Regulatory Context
510(k) Submission Activity
1311 total 510(k) submissions under product code HRS since 1976, with 1311 receiving FDA clearance (average review time: 116 days).
Submission volume has increased in recent years - 118 submissions in the last 24 months compared to 79 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - HRS Product Code
FDA review times for HRS submissions have been consistent, averaging 106 days recently vs 117 days historically.
HRS devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →