Arthrex ECLIPSE™ Total Shoulder Arthroplasty System. Catalog #AR-9301-39CPC

Vendor/Manufacturer: Arthrex

Product/Product Line: ECLIPSE™ Total Shoulder Arthroplasty System

Vendor/Manufacturer Catalog #: AR-9301-39CPC

Global Unique Device (GUD) Primary Device Identifier Number: 00888867276123

Global Unique Device (GUD) Device Description:

ECLIPSE TRUNION 39MM, SLOTTED, TPS CaP

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): 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

For more information, please visit us at Infonomics.com