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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 a medical device manufactured by Shoulder Innovations, Inc.. It received FDA 510(k) clearance on 2025-02-11 under approval 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. It is manufactured by Shoulder Innovations, Inc.. The 510(k) number is K241817.

When was InSet Total Shoulder System approved by the FDA?

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

What company makes InSet Total Shoulder System?

InSet Total Shoulder System is manufactured by Shoulder Innovations, Inc..

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

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

Related Clinical Trials

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Related PubMed Literature

PMID: 42173476 Feasibility of applying the Orthopaedic Data Evaluation Panel (ODEP) shoulder criteria for implants used in a United States-based integrated healthcare system. Journal of shoulder and elbow surgery (2026) PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026)

Other Devices by Shoulder Innovations, Inc.

K173824Humeral Short Stem System K192365Shoulder Innovations Total Shoulder System K210533Inset Reverse Total Shoulder System K213615Shoulder Innovations Total Shoulder System K252221Inset Reverse Total Shoulder System K254128InSet Reverse Total Shoulder System

View all 8 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.

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