Arthrex ECLIPSE™ Total Shoulder Arthroplasty System. Catalog #AR-9355-21

Vendor/Manufacturer: Arthrex

Product/Product Line: ECLIPSE™ Total Shoulder Arthroplasty System

Vendor/Manufacturer Catalog #: AR-9355-21

Global Unique Device (GUD) Primary Device Identifier Number: 00888867139510

Global Unique Device (GUD) Device Description:

ARTHREX ECLIPSE HUMERAL HEAD, 55/21

Global Medical Device Nomenclature (GMDN) Preferred Term Name:

Uncoated 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 not coated with a material intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws) may be included and implantation is intended to be performed with 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): QHQ

FDA Classification Product Code Device Name(s):

Total shoulder arthroplasty system

FDA Premarket Submission: K183194 The Arthrex ECLIPSE™ Total Shoulder Arthroplasty System is SUBSTANTIALLY EQUIVALENT to the following product(s): 1. Simpliciti Shoulder System

2. Sidus Stem-Free Shoulder

3. Arthrex Univers II Shoulder Prosthesis

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