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 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 the device name listed in this FDA 510(k) record. The listed applicant is Implantcast GmbH. It received FDA 510(k) clearance on 2022-09-28 under 510(k) 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. The listed applicant is Implantcast GmbH. The 510(k) number is K222482.

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

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

Who is the listed applicant for AGILON XO Shoulder 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 System?

The FDA product code for AGILON XO Shoulder 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 stemsK241944AGILON® XO Shoulder Replacement SystemK240391MUTARS® femoral stem cemented 160 mm and 200 mmK234044ACS® LD FB Knee System

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.K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbHK241817InSet Total Shoulder SystemShoulder Innovations, Inc.K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbHK223631Comprehensive Segmental Revision System(SRS)Biomet 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.

↑