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FDA 510(k)

InSet Reverse Total Shoulder System

K-Number: K254128 · 2026-04-13

ApplicantShoulder Innovations, Inc.
Decision Date2026-04-13
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

InSet Reverse 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 2026-04-13 under 510(k) number K254128. The device is classified under product code PHX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the InSet Reverse Total Shoulder System?

InSet Reverse Total Shoulder System is a medical device that received FDA 510(k) clearance on 2026-04-13. The listed applicant is Shoulder Innovations, Inc.. The 510(k) number is K254128.

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

InSet Reverse Total Shoulder System received FDA 510(k) clearance on 2026-04-13, under 510(k) number K254128.

Who is the listed applicant for InSet Reverse 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 Reverse Total Shoulder System?

The FDA product code for InSet Reverse Total Shoulder System is PHX.

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.

K252516N22 EZ GlenosphereK252221Inset Reverse Total Shoulder SystemK241817InSet Total Shoulder SystemK213615Shoulder Innovations Total Shoulder SystemK210533Inset Reverse Total Shoulder SystemK192365Shoulder Innovations Total Shoulder System

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Related Devices (Code: PHX)

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.

K260556Veritas Shoulder SystemRestor3DK261683Augment Off-Axis Instrument SystemZimmer, Inc.K260102Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder SystemStryker Corporation (Tornier, Inc.)K261016MSS - Humeral reverse liners extensionMedacta International, SAK253992Veritas Reverse Total Shoulder SystemRestor3DK252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics

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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