DePuy DELTA XTEND™ Reverse Shoulder System. Catalog # 130748026

Vendor/Manufacturer: DePuy Synthes

Product/Product Line: DELTA XTEND™ Reverse Shoulder System

Vendor/Manufacturer Catalog #: 130748026

Global Unique Device (GUD) Primary Device Identifier Number: 10603295027706

Global Unique Device (GUD) Device Description:

DELTA Xtend CTA Head Dia 48 x 26 mm

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

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: K203694 , K062250 , K120174 , K192855 , K071379 , K192448

The DePuy DELTA XTEND™ Reverse Shoulder System is SUBSTANTIALLY EQUIVALENT to the following product(s):

1. Tornier Aequalis Reversed Fracture Shoulder Prosthesis

2. Tornier Aequalis PerFORM Reversed Shoulder Prosthesis

3. Tornier Aequalis PerFORM+ Reversed Glenoid Shoulder Prosthesis

4. Comprehensive® Reverse Shoulder System

5. DePuy Delta CTA Reverse Shoulder System

6. DePuy Global Advantage Shoulder System

7. DePuy Synthes GLOBAL UNITE Platform Shoulder System

For more information, please visit us at Infonomics.com