Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button

K-Number: K260353 · 2026-03-03

ApplicantArthrex, Inc.
Decision Date2026-03-03
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2026-03-03 under approval number K260353. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button?

Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button is a medical device that received FDA 510(k) clearance on 2026-03-03. It is manufactured by Arthrex, Inc.. The 510(k) number is K260353.

When was Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button approved by the FDA?

Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button received FDA 510(k) clearance on 2026-03-03, under approval number K260353.

What company makes Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button?

Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button is manufactured by Arthrex, Inc..

What is the FDA product code for Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button?

The FDA product code for Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button is HRS.

Related Clinical Trials

NCT03262415 PRECISION Study: Evaluating the Accuracy of the LabPatch Continuous Glucose Monitor COMPLETED NCT05019664 Affixus Natural Nail System Humeral Nail PMCF ACTIVE_NOT_RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT06409559 Rim Plate to Buttress Plate for Posterior Wall Acetabular Fractures With and Without Inter-fragmentary Screws RECRUITING NCT06660186 Sternal Plating High Risk RECRUITING NCT07421245 OsseoFit Stemless Shoulder System (Anatomic) NOT_YET_RECRUITING

Other Devices by Arthrex, Inc.

K161060Arthrex iBalance UKA System Vitamin E Tibial Bearing K161782Arthrex Univers Revers Shoulder Prosthesis System K161581Arthrex Synergy RF System K161108Arthrex VaultLock Glenoid K160319FiberTak DR K151527Arthrex Univers Revers CA Heads and Adapters

View all 168 devices →

Related Devices (Code: HRS)

K163086VLP MINI-MOD 2.0mm Column PlatesSmith & Nephew, Inc. K162829Medline UNITE® Ankle Fracture Plating SystemMedline Industries, Inc. K162974Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation K163007Biomet Microfixation SternaLock 360 Sternal Closure SystemBiomet Microfixation K161696aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5Aap Implantate AG K161747LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5; LOQTEQ® VA Distal Anterolateral Tibia Plate 3.5; LOQTEQ® VA Distal Fibula Plate 2.7/3.5Aap Implantate AG

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑