DePuy GLOBAL® UNITE® Platform Shoulder System. Catalog #1100-14-100

Vendor/Manufacturer: DePuy Synthes

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

Vendor/Manufacturer Catalog #: 1100-14-100

Global Unique Device (GUD) Primary Device Identifier Number: 10603295004158

Global Unique Device (GUD) Device Description:

GLOBAL UNITE POROCOAT STANDARD STEM SIZE 14 129mm

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, MBF, PHX

FDA Classification Product Code Device Name(s):

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

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

MBF: Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented

PHX: Shoulder Prosthesis, Reverse Configuration

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

2. DePuy Global AP Shoulder System

3. DePuy Delta Xtend Shoulder System

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