Cleared Traditional

AGILON XO Shoulder System

K222482 · Implantcast GmbH · Orthopedic

Sep 2022

Decision

42d

Days

Class 2

Risk

About This 510(k) Submission

K222482 is an FDA 510(k) clearance for the AGILON XO Shoulder 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 September 28, 2022, 42 days after receiving the submission on August 17, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3650.

Submission Details

510(k) Number	K222482 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 17, 2022
Decision Date	September 28, 2022
Days to Decision	42 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