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

Growing category - 115 submissions in the last 2 years vs 89 in the prior period

Consistent review times: 100d avg (recent)

FDA 510(k) Cleared Plate, Fixation, Bone Devices (Product Code HRS)

1333 devices

1–24 of 1333

1 2 3 4

Cleared Oct 29, 2026

Arthrex Plates, Screws and Pins, and Washers

Trochlear Salvage Plating System

K261135

Skeletal Dynamics, Inc.

Orthopedic · 202d

Cleared Oct 23, 2026

ANTHEM™ Fracture System

TDM Large Bone Plate and Screw System

ProRib Fixation System

EnHAnce PEEK Bunion System

K262098

Nvision Biomedical Technologies

Orthopedic · 88d

Cleared Sep 15, 2026

TMC Implant Fixation System

K262963

Treace Medical Concepts, Inc.

FRAXION 3.5 Plate System (Various - See Catalog)

K261830

Ortler Global Tibbi Gerecler Anonim Sirketi

Orthopedic · 87d

Cleared Aug 19, 2026

Versalock Sterile Plating System

K262537

GM Dos Reis Industria e Comercio Ltda.

Orthopedic · 27d

Cleared Aug 13, 2026

MIKRON TRAUMA BONE PLATE& SCREW SYSTEM

K260277

Mikron Makina San. ve Tic. Ltd. Sti.

Versalock Proximal Tibial Plating System

K261406

GM Dos Reis Industria e Comercio Ltda.

Orthopedic · 83d

Cleared Jul 16, 2026

TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD)

Stryker Leibinger GmbH & Co KG

Orthopedic · 92d

Cleared Jun 26, 2026

SALGINA 2.5mm Distal Radius System

I.T.S. Clavicle Plates with Angular Stability

Exalta Proximal Tibia Plating System

APTUS Clavicle System 2.8

1 2 3 4

About Product Code HRS - Regulatory Context

510(k) Submission Activity

1333 total 510(k) submissions under product code HRS since 1976, with 1333 receiving FDA clearance (average review time: 115 days).

Submission volume has increased in recent years - 115 submissions in the last 24 months compared to 89 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 100 days recently vs 117 days historically.

HRS devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →

FDA Product Code HRS: Plate, Fixation, Bone

FDA 510(k) Cleared Plate, Fixation, Bone Devices (Product Code HRS)

About Product Code HRS - Regulatory Context

510(k) Submission Activity

FDA 510(k) Review Time - HRS Product Code

Related FDA 510(k) Regulatory Insights