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FDA 510(k)

AGILON® XO Shoulder Replacement System

K-Number: K231657 · 2024-02-16

ApplicantImplantcast GmbH
Decision Date2024-02-16
Product CodeKWT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AGILON® XO Shoulder Replacement System is a medical device manufactured by Implantcast GmbH. It received FDA 510(k) clearance on 2024-02-16 under approval number K231657. 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 2024-02-16. It is manufactured by Implantcast GmbH. The 510(k) number is K231657.

When was AGILON® XO Shoulder Replacement System approved by the FDA?

AGILON® XO Shoulder Replacement System received FDA 510(k) clearance on 2024-02-16, under approval number K231657.

What company makes AGILON® XO Shoulder Replacement System?

AGILON® XO Shoulder Replacement System is manufactured by Implantcast GmbH.

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

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

Related Clinical Trials

NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING NCT07601269 Replacement of the Native Mitral Valve Using the ReValve System RECRUITING NCT06414265 Reduction of Mitral Regurgitation With the SATURN Trans-Septal Transcatheter Mitral Valve Replacement (TMVR) System in Patients With Severe Symptomatic Mitral Regurgitation RECRUITING NCT06608823 ARTIST: Aortic Regurgitation Trial Investigating Surgery Versus Trilogy™ RECRUITING NCT03242642 Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation. RECRUITING NCT07276711 CAPTURE-2: Controlled Arterial Protection to Ultimately Remove Embolic Material RECRUITING

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)

Other Devices by Implantcast GmbH

K163577Ecofit® Hip System K180263EcoFit Vit E Acetabular System K191569Implantcast ic-Bipolar Head System K181778MUTARS Proximal Femur Replacement System K191433AGILON® XO Shoulder Replacement System K200045MUTARS Cemented Femoral Stems

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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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