Mosaic Non-Modular Proximal Body and Eas Offset Modular Humeral Head

Q: What is the product code of K042321?

The FDA product code is KWT – Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented, a Class II (moderate risk) device regulated under 21 CFR 888.3650.

FDA 510(k) K042321 · Biomet Manufacturing Corp

Substantially Equivalent

510(k) numberK042321

Submission

Device name: Mosaic Non-Modular Proximal Body and Eas Offset Modular Humeral Head
Applicant: Biomet Manufacturing Corp
Warsaw, IN, US
Received: August 26, 2004
Decision date: January 28, 2005
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: KWT – Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Device class: Class II (moderate risk)
Regulation: 21 CFR 888.3650
Specialty: Orthopedic
Implant: Yes

Other 510(k)s with product code KWT

510(k)	Device	Applicant	Decision
K262173	N22 Offset Humeral HeadKWT · Traditional	Shoulder Innovations, Inc.	09/08/2026SE
K250713	Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsKWT · Traditional	Exactech, Inc.	12/01/2025SE
K251686	Tornier Humeral Reconstruction System Max (Tornier HRS Max)KWT · Traditional	Tornier, Inc.	10/30/2025SE
K241944	AGILON® XO Shoulder Replacement SystemKWT · Traditional	Implantcast GmbH	03/10/2025SE
K241817	InSet Total Shoulder SystemKWT · Traditional	Shoulder Innovations, Inc.	02/11/2025SE
K231657	AGILON® XO Shoulder Replacement SystemKWT · Traditional	Implantcast GmbH	02/16/2024SE
K223631	Comprehensive Segmental Revision System(SRS)KWT · Traditional	Biomet Orthopedics	07/12/2023SE
K222482	AGILON XO Shoulder SystemKWT · Traditional	Implantcast GmbH	09/28/2022SE
K210899	LINK Embrace Shoulder System- Anatomical ConfigurationKWT · Traditional	Waldemar Link GmbH & Co. KG	06/21/2021SE
K191698	TiN Coated Humeral HeadKWT · Traditional	Fx Shoulder USA, Inc.	07/16/2020SE

More from Fx Shoulder USA, Inc.

510(k)	Device	Decision
K230540	Patient Specific Planning Solution 3D Bone ModelsLLZ · Traditional	07/25/2023SE
K214001	Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder SystemPHX · Traditional	03/15/2023SE
K211729	Comprehensive® Convertible Glenoid - Vivacit-E LinerPHX · Traditional	11/04/2021SE
K202232	Comprehensive Vault Reconstruction SystemPHX · Traditional	02/19/2021SE
K193038	Comprehensive Shoulder SystemMBF · Traditional	10/28/2020SE
K182516	Comprehensive Nano Stemless ShoulderPKC · Traditional	04/22/2019SE
K181611	Comprehensive Reverse Shoulder SystemPHX · Traditional	09/24/2018SE
K173411	Comprehensive Segmental Revision System (SRS)PHX · Traditional	02/08/2018SE
K172502	Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate…PHX · Traditional	01/03/2018SE
K163651	ExpressBraid Graft ManipulationGAT · Traditional	02/17/2017SE

Questions and answers

When was Mosaic Non-Modular Proximal Body and Eas Offset Modular Humeral Head cleared by the FDA?

Mosaic Non-Modular Proximal Body and Eas Offset Modular Humeral Head (K042321) received a 510(k) decision of Substantially Equivalent on January 28, 2005, 155 days after the submission was received.

What is the product code of K042321?

The FDA product code is KWT – Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented, a Class II (moderate risk) device regulated under 21 CFR 888.3650.