AGILON® XO Shoulder Replacement System

Q: What is the product code of K191433?

The FDA product code is HSD – Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented, a Class II (moderate risk) device regulated under 21 CFR 888.3690.

FDA 510(k) K191433 · Implantcast GmbH

Substantially Equivalent

510(k) numberK191433

Submission

Device name: AGILON® XO Shoulder Replacement System
Applicant: Implantcast GmbH
Buxtehude, DE
Received: May 29, 2019
Decision date: November 12, 2020
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: HSD – Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Device class: Class II (moderate risk)
Regulation: 21 CFR 888.3690
Specialty: Orthopedic
Implant: Yes

Other 510(k)s with product code HSD

510(k)	Device	Applicant	Decision
K233260	Univers Revers CA Head and AdapterHSD · Traditional	Arthrex, Inc.	02/12/2024SE
K221232	Univers Revers Humeral Cup ImplantHSD · Special	Arthrex, Inc.	05/19/2022SE
K193122	Biocore9 Humeral Resurfacing SystemHSD · Traditional	Biocore9, LLC	05/15/2020SE
K173964	OVOMotion Shoulder Arthroplasty SystemHSD · Traditional	Arthrosurface, Inc.	04/18/2018SE
K161782	Arthrex Univers Revers Shoulder Prosthesis SystemHSD · Traditional	Arthrex, Inc.	11/21/2016SE
K161620	Anatomical Shoulder Domelock Dome centricHSD · Traditional	Zimmer GmbH	11/01/2016SE
K151527	Arthrex Univers Revers CA Heads and AdaptersHSD · Traditional	Arthrex, Inc.	04/19/2016SE
K142942	HemiCAP Humeral Head XL (HHXL) Articular Resurfacing SystemHSD · Special	Arthrosurface, Inc.	12/19/2014SE
K131298	Exactech Equinoxe Resurfacing Humeral Head SystemHSD · Traditional	Exactech, Inc.	11/26/2013SE
K130759	Humelock II Cementless Shoulder SystemHSD · Traditional	Fx Solutions	11/09/2013SE

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K240834	EcoFit® short stem cementless cpTiLZO · Traditional	06/03/2024SE
K231657	AGILON® XO Shoulder Replacement SystemKWT · Traditional	02/16/2024SE
K232371	Actinia® hip stemsLZO · Traditional	10/19/2023SE
K223103	BethaLoc® stem cementless HALZO · Traditional	06/20/2023SE

Questions and answers

When was AGILON® XO Shoulder Replacement System cleared by the FDA?

AGILON® XO Shoulder Replacement System (K191433) received a 510(k) decision of Substantially Equivalent on November 12, 2020, 533 days after the submission was received.

What is the product code of K191433?

The FDA product code is HSD – Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented, a Class II (moderate risk) device regulated under 21 CFR 888.3690.