Arthrex ECLIPSE™ Total Shoulder Arthroplasty System. Catalog #AR-9337-16T

Vendor/Manufacturer: Arthrex

Product/Product Line: ECLIPSE™ Total Shoulder Arthroplasty System

Vendor/Manufacturer Catalog #: AR-9337-16T

Global Unique Device (GUD) Primary Device Identifier Number: 00888867287556

Global Unique Device (GUD) Device Description:

ECLIPSE TI HUMERAL HEAD, SIZE 37/16

Global Medical Device Nomenclature (GMDN) Preferred Term Name:

Total shoulder prosthesis

Global Medical Device Nomenclature (GMDN) Definition:

A sterile implantable artificial substitute for a shoulder joint designed to replace both articulating surfaces of the damaged (e.g., fractured) and/or degenerative (e.g., arthritic) joint. It includes glenoid and humeral (head and stem) components typically with parts made of metal and polyethylene (PE). 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): PKC

FDA Classification Product Code Device Name(s):

Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained

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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