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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 the device name listed in this FDA 510(k) record. The listed applicant is Tornier, Inc.. It received FDA 510(k) clearance on 2025-10-30 under 510(k) 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. The listed applicant is Tornier, Inc.. The 510(k) number is K251686.

When did Tornier Humeral Reconstruction System Max (Tornier HRS Max) receive FDA 510(k) clearance?

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

Who is the listed applicant for Tornier Humeral Reconstruction System Max (Tornier HRS Max)?

The FDA 510(k) record lists Tornier, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05500066Tornier HRS (Humeral Reconstruction System) Study (REVIVE)ENROLLING_BY_INVITATIONNCT05773352Perform® Humeral System - Fracture Study (PFX)ACTIVE_NOT_RECRUITING

Other records listing Tornier, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260721Tornier Perform Advanced GlenoidK252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)K230352Tornier Humeral Nail and Tornier Long Humeral NailK220914Tornier Perform Humeral System – FractureK220418Tornier Perform Humeral System – StemlessK211359Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient Specific Instrumentation

View all 19 devices →

Related Devices (Code: KWT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250713Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsExactech, Inc.K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbHK241817InSet Total Shoulder SystemShoulder Innovations, Inc.K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbHK223631Comprehensive Segmental Revision System(SRS)Biomet OrthopedicsK222482AGILON XO Shoulder SystemImplantcast GmbH

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.

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