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FDA 510(k)

AGILON® XO Shoulder Replacement System

K-Number: K191433 · 2020-11-12

ApplicantImplantcast GmbH
Decision Date2020-11-12
Product CodeHSD
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 2020-11-12 under approval number K191433. The device is classified under product code HSD. 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 2020-11-12. It is manufactured by Implantcast GmbH. The 510(k) number is K191433.

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

AGILON® XO Shoulder Replacement System received FDA 510(k) clearance on 2020-11-12, under approval number K191433.

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 HSD.

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)

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Related Devices (Code: HSD)

K161782Arthrex Univers Revers Shoulder Prosthesis SystemArthrex, Inc. K161620Anatomical Shoulder Domelock Dome centricZimmer GmbH K151527Arthrex Univers Revers CA Heads and AdaptersArthrex, Inc. K173964OVOMotion Shoulder Arthroplasty SystemArthrosurface, Inc. K193122Biocore9 Humeral Resurfacing SystemBiocore9, LLC K221232Univers Revers Humeral Cup ImplantArthrex, 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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