Cleared Traditional

AGILON? XO Shoulder Replacement System

K191433 · Implantcast GmbH · Orthopedic
Nov 2020
Decision
533d
Days
Class 2
Risk

About This 510(k) Submission

K191433 is an FDA 510(k) clearance for the AGILON? XO Shoulder Replacement System, a Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented (Class II — Special Controls, product code HSD), submitted by Implantcast GmbH (Buxtehude, DE). The FDA issued a Cleared decision on November 12, 2020, 533 days after receiving the submission on May 29, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3690.

Submission Details

510(k) Number K191433 FDA.gov
FDA Decision Cleared SESE
Date Received May 29, 2019
Decision Date November 12, 2020
Days to Decision 533 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HSD — Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3690

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