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
Growing category -
114 submissions in the last 2 years
vs 85 in the prior period
Consistent review times:
102d avg (recent)
FDA 510(k) Cleared Plate, Fixation, Bone Devices (Product Code HRS)
1322 devices
Cleared
Aug 28, 2026
FRAXION 3.5 Plate System (Various - See Catalog)
Ortler Global Tibbi Gerecler Anonim Sirketi
Orthopedic
87d
Cleared
Aug 19, 2026
Versalock Sterile Plating System
GM Dos Reis Industria e Comercio Ltda.
Orthopedic
27d
Cleared
Aug 13, 2026
MIKRON TRAUMA BONE PLATE& SCREW SYSTEM
Mikron Makina San. ve Tic. Ltd. Sti.
Orthopedic
196d
Cleared
Jul 28, 2026
Xpert Ankle
Newclip Technics
Orthopedic
82d
Cleared
Jul 21, 2026
Versalock Proximal Tibial Plating System
GM Dos Reis Industria e Comercio Ltda.
Orthopedic
83d
Cleared
Jul 16, 2026
TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD)
TriMed, Inc.
Orthopedic
29d
Cleared
Jul 08, 2026
Alians Elbow S
Newclip Technics
Orthopedic
86d
Cleared
Jul 01, 2026
RibPlate System
Stryker Leibinger GmbH & Co KG
Orthopedic
92d
Cleared
Jun 26, 2026
SALGINA 2.5mm Distal Radius System
Bonebridge AG
Orthopedic
63d
Cleared
Jun 16, 2026
I.T.S. Clavicle Plates with Angular Stability
I.T.S. GmbH
Orthopedic
85d
Cleared
Jun 12, 2026
Exalta Proximal Tibia Plating System
Tyber Medical, LLC
Orthopedic
60d
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
About Product Code HRS - Regulatory Context
510(k) Submission Activity
1322 total 510(k) submissions under product code HRS since 1976, with 1322 receiving FDA clearance (average review time: 116 days).
Submission volume has increased in recent years - 114 submissions in the last 24 months compared to 85 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 102 days recently vs 117 days historically.
HRS devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →