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FDA 510(k)

InSet Total Shoulder System

K-Number: K241817 · 2025-02-11

ApplicantShoulder Innovations, Inc.
Decision Date2025-02-11
Product CodeKWT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

InSet Total Shoulder System is the device name listed in this FDA 510(k) record. The listed applicant is Shoulder Innovations, Inc.. It received FDA 510(k) clearance on 2025-02-11 under 510(k) number K241817. 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 InSet Total Shoulder System?

InSet Total Shoulder System is a medical device that received FDA 510(k) clearance on 2025-02-11. The listed applicant is Shoulder Innovations, Inc.. The 510(k) number is K241817.

When did InSet Total Shoulder System receive FDA 510(k) clearance?

InSet Total Shoulder System received FDA 510(k) clearance on 2025-02-11, under 510(k) number K241817.

Who is the listed applicant for InSet Total Shoulder System?

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

What is the FDA product code for InSet Total Shoulder System?

The FDA product code for InSet Total Shoulder System is KWT.

Other records listing Shoulder Innovations, 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.

K254128InSet Reverse Total Shoulder SystemK252516N22 EZ GlenosphereK252221Inset Reverse Total Shoulder SystemK213615Shoulder Innovations Total Shoulder SystemK210533Inset Reverse Total Shoulder SystemK192365Shoulder Innovations Total Shoulder System

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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.K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbHK231657AGILON® 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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