Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

AGILON® XO Shoulder Replacement System

K-Number: K241944 · 2025-03-10

ApplicantImplantcast GmbH
Decision Date2025-03-10
Product CodeKWT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AGILON® XO Shoulder Replacement System is the device name listed in this FDA 510(k) record. The listed applicant is Implantcast GmbH. It received FDA 510(k) clearance on 2025-03-10 under 510(k) number K241944. 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 AGILON® XO Shoulder Replacement System?

AGILON® XO Shoulder Replacement System is a medical device that received FDA 510(k) clearance on 2025-03-10. The listed applicant is Implantcast GmbH. The 510(k) number is K241944.

When did AGILON® XO Shoulder Replacement System receive FDA 510(k) clearance?

AGILON® XO Shoulder Replacement System received FDA 510(k) clearance on 2025-03-10, under 510(k) number K241944.

Who is the listed applicant for AGILON® XO Shoulder Replacement System?

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

What is the FDA product code for AGILON® XO Shoulder Replacement System?

The FDA product code for AGILON® XO Shoulder Replacement System is KWT.

Other records listing Implantcast GmbH 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.

K252451EPORE® XO cup systemK260037implantcast Packaging System UpdateK252401implaFit® short stemsK240391MUTARS® femoral stem cemented 160 mm and 200 mmK234044ACS® LD FB Knee SystemK240834EcoFit® short stem cementless cpTi

View all 20 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.K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.K241817InSet 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.

↑