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)

Tornier Humeral Reconstruction System Max (Tornier HRS Max)

K-Number: K251686 · 2025-10-30

ApplicantTornier, Inc.
Decision Date2025-10-30
Product CodeKWT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Tornier Humeral Reconstruction System Max (Tornier HRS Max) is a medical device manufactured by Tornier, Inc.. It received FDA 510(k) clearance on 2025-10-30 under approval number K251686. The device is classified under product code KWT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tornier Humeral Reconstruction System Max (Tornier HRS Max)?

Tornier Humeral Reconstruction System Max (Tornier HRS Max) is a medical device that received FDA 510(k) clearance on 2025-10-30. It is manufactured by Tornier, Inc.. The 510(k) number is K251686.

When was Tornier Humeral Reconstruction System Max (Tornier HRS Max) approved by the FDA?

Tornier Humeral Reconstruction System Max (Tornier HRS Max) received FDA 510(k) clearance on 2025-10-30, under approval number K251686.

What company makes Tornier Humeral Reconstruction System Max (Tornier HRS Max)?

Tornier Humeral Reconstruction System Max (Tornier HRS Max) is manufactured by Tornier, Inc..

What is the FDA product code for Tornier Humeral Reconstruction System Max (Tornier HRS Max)?

The FDA product code for Tornier Humeral Reconstruction System Max (Tornier HRS Max) is KWT.

Related Clinical Trials

NCT07489820 Evaluation of the Efficacy of Negative Pressure Wound Therapy on Perineal Healing Following Abdominoperineal Amputation NOT_YET_RECRUITING NCT05019664 Affixus Natural Nail System Humeral Nail PMCF ACTIVE_NOT_RECRUITING NCT04289480 Safety and Effectiveness of ENTERPRISE 2 Device in the Endovascular Treatment of Intracranial Aneurysms ACTIVE_NOT_RECRUITING NCT06385379 Guo's Aortic Arch Reconstruction: A Multicenter, Prospective Study of the Novel WeFlow-Tribranch System (GENIUS Study) RECRUITING NCT06878768 Translational Research GRICS-CineCardiac COMPLETED NCT06638138 Study of Artelon FLEXBAND® for Patients Undergoing Soft Tissue Reconstruction of the Anterior Talofibular Ligament (ATFL) to Treat Lateral Ankle Instability COMPLETED

Other Devices by Tornier, Inc.

K161742Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid K160975Aequalis PerFORM+ Shoulder System K171010Latitude EV Total Elbow Arthroplasty K182461LATITUDE EV Total Elbow Arthroplasty K181587ORTHOLOC SPS Shoulder Plating System K181420Aequalis Flex Revive Shoulder System

View all 18 devices →

Related Devices (Code: KWT)

K161476SMR Shoulder SystemLima Corporate S.P.A. K152825Catalyst CSR Shoulder SystemCatalyst Orthoscience, LLC K162903Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal BodiesExactech, Inc. K181287Catalyst CSR Shoulder SystemCatalyst Orthoscience, Inc. K173812Catalyst CSR 3 Peg GlenoidsCatalyst Orthoscience, Inc. K192365Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.

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.

↑