Zimmer Biomet COMPREHENSIVE® Reverse Shoulder System. Catalog #113604

Vendor/Manufacturer: Zimmer Biomet

Product/Product Line: COMPREHENSIVE® Reverse Shoulder System

Vendor/Manufacturer Catalog #: 113604

Global Unique Device (GUD) Primary Device Identifier Number: 00887868267543

Global Unique Device (GUD) Device Description:

Comprehensive Humeral Stem—Micro, 4mm

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: 888.3670

FDA Regulation Description Classification Name:

Shoulder joint metal/polymer/metal non-constrained or semi-constrained porous-coated uncemented prosthesis

FDA Classification Product Code(s): HSD, KWS, KWT, MBF

FDA Classification Product Code Device Name(s):

HSD: Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

KWS: Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

KWT: Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented

MBF: Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented

FDA Premarket Submission(s): K060692 , K193038 , K023063 , K080642 , K132239 , K193373