DePuy GLOBAL® UNITE® Platform Shoulder System. Catalog #1100-30-000

CataBlog
Jul 14, 2022
1 min read

Updated: Jul 16, 2022

Vendor/Manufacturer: DePuy Synthes

Product/Product Line: GLOBAL® UNITE® Platform Shoulder System

Vendor/Manufacturer Catalog #: 1100-30-000

Global Unique Device (GUD) Primary Device Identifier Number: 10603295004356

Global Unique Device (GUD) Device Description:

GLOBAL UNITE ANATOMIC PROXIMAL BODY 135 DEGREE SIZE 10 POROCOAT

Global Medical Device Nomenclature (GMDN) Preferred Term Name:

Coated shoulder humeral stem prosthesis

Global Medical Device Nomenclature (GMDN) Definition:

A sterile implantable device designed to provide fixation within the proximal humerus and a site of attachment for a humeral head or humeral body prosthesis as part of a shoulder joint replacement. The device is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement.

FDA Regulation Medical Specialty:

Orthopedic Devices - Prosthetic Devices

FDA Regulation Number: 888.3660

FDA Regulation Description Classification Name:

Shoulder joint metal/polymer semi-constrained cemented prosthesis

FDA Classification Product Code(s): HSD, KWS

FDA Classification Product Code Device Name(s):

HSD: Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

KWS: Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

FDA Premarket Submission: K170748 , K101996 , K133834 The GLOBAL® UNITE® Platform Shoulder System is SUBSTANTIALLY EQUIVALENT to the following product(s): 1. Zimmer Trabecular Metal® Reverse Shoulder System