DePuy GLOBAL® UNITE® Platform Shoulder System. Catalog #1100-40-510

Vendor/Manufacturer: DePuy Synthes

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

Vendor/Manufacturer Catalog #: 1100-40-510

Global Unique Device (GUD) Primary Device Identifier Number: 10603295004486

Global Unique Device (GUD) Device Description:

GLOBAL UNITE STANDARD HUMERAL HEAD SIZE 40mm x 18mm

Global Medical Device Nomenclature (GMDN) Preferred Term Name:

Stem-fixed humeral head prosthesis

Global Medical Device Nomenclature (GMDN) Definition:

A sterile implantable artificial substitute for a diseased or injured humeral head. It is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] and designed to be attached to a humeral stem prosthesis and to articulate with the natural glenoid fossa, a glenoid fossa prosthesis, or a humeral head bipolar component as part of a shoulder replacement.

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

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

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

2. DePuy Global AP Shoulder System

3. DePuy Delta Xtend Shoulder System

4. DePuy Global Advantage Humeral Stem with Porocoat

5. DePuy Global Advantage Humeral Stem

6. DePuy Global Advantage Shoulder

7. DePuy Global Advantage Eccentric Head

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