Vendor/Manufacturer: Arthrex
Product/Product Line: ECLIPSE™ Total Shoulder Arthroplasty System
Vendor/Manufacturer Catalog #: AR-9301-37CPC
Global Unique Device (GUD) Primary Device Identifier Number: 00888867276116
Global Unique Device (GUD) Device Description:
ECLIPSE TRUNION 37MM, 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): 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
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