Vendor/Manufacturer: DePuy Synthes
Product/Product Line: GLOBAL® UNITE® Platform Shoulder System
Vendor/Manufacturer Catalog #: 1100-20-000
Global Unique Device (GUD) Primary Device Identifier Number: 10603295433217
Global Unique Device (GUD) Device Description:
GLOBAL UNITE POROCOAT ANATOMIC PROXIMAL BODY 135 DEGREE SIZE 6/8 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
For more information, please visit us at Infonomics.com
Comments