Cleared Traditional

AGILON? XO Shoulder Replacement System

K241944 · Implantcast GmbH · Orthopedic

Mar 2025

Decision

251d

Days

Class 2

Risk

About This 510(k) Submission

K241944 is an FDA 510(k) clearance for the AGILON? XO Shoulder Replacement System, a Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented (Class II — Special Controls, product code KWT), submitted by Implantcast GmbH (Buxtehude, DE). The FDA issued a Cleared decision on March 10, 2025, 251 days after receiving the submission on July 2, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3650.

Submission Details

510(k) Number	K241944 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 02, 2024
Decision Date	March 10, 2025
Days to Decision	251 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	KWT — Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3650