Cleared Traditional

AGILON? XO Shoulder Replacement System

K231657 · Implantcast GmbH · Orthopedic

Feb 2024

Decision

254d

Days

Class 2

Risk

About This 510(k) Submission

K231657 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 February 16, 2024, 254 days after receiving the submission on June 7, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3650.

Submission Details

510(k) Number	K231657 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 07, 2023
Decision Date	February 16, 2024
Days to Decision	254 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