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FDA 510(k)

INHANCE™ Reverse Shoulder System

K-Number: K253624 · 2026-03-11

ApplicantDepuy Ireland UC
Decision Date2026-03-11
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

INHANCE™ Reverse Shoulder System is the device name listed in this FDA 510(k) record. The listed applicant is Depuy Ireland UC. It received FDA 510(k) clearance on 2026-03-11 under 510(k) number K253624. 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 INHANCE™ Reverse Shoulder System?

INHANCE™ Reverse Shoulder System is a medical device that received FDA 510(k) clearance on 2026-03-11. The listed applicant is Depuy Ireland UC. The 510(k) number is K253624.

When did INHANCE™ Reverse Shoulder System receive FDA 510(k) clearance?

INHANCE™ Reverse Shoulder System received FDA 510(k) clearance on 2026-03-11, under 510(k) number K253624.

Who is the listed applicant for INHANCE™ Reverse Shoulder System?

The FDA 510(k) record lists Depuy Ireland UC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INHANCE™ Reverse Shoulder System?

The FDA product code for INHANCE™ Reverse Shoulder System is PHX.

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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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