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FDA 510(k)

AGILON XO Shoulder System

K-Number: K222482 · 2022-09-28

ApplicantImplantcast GmbH
Decision Date2022-09-28
Product CodeKWT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AGILON XO Shoulder System is a medical device manufactured by Implantcast GmbH. It received FDA 510(k) clearance on 2022-09-28 under approval number K222482. 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 System?

AGILON XO Shoulder System is a medical device that received FDA 510(k) clearance on 2022-09-28. It is manufactured by Implantcast GmbH. The 510(k) number is K222482.

When was AGILON XO Shoulder System approved by the FDA?

AGILON XO Shoulder System received FDA 510(k) clearance on 2022-09-28, under approval number K222482.

What company makes AGILON XO Shoulder System?

AGILON XO Shoulder System is manufactured by Implantcast GmbH.

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

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

Related Clinical Trials

NCT04816825 Home-monitored Telerehabilitation in COPD Patients COMPLETED NCT05951491 Improving Arm Function Using Wearable Exoskeletons SUSPENDED NCT04984291 Zimmer Biomet Shoulder Arthroplasty PMCF RECRUITING NCT01480440 Outcomes Study of the Trabecular Metal (TM) Reverse Shoulder System ACTIVE_NOT_RECRUITING NCT07550543 PEMF Therapy in Shoulder Tendinopathy RECRUITING NCT07421245 OsseoFit Stemless Shoulder System (Anatomic) NOT_YET_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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