JRI VAIOS Mode D'emploi page 3

Important Information
Please read instructions for use and corresponding operative technique, prior to use in a clinical setting. The
Surgeon should be familiar with the appropriate operative technique.
Material(s)
Material(s)
Titanium Alloy
Cobalt Chrome
Ultra-High Molecular Weight
Polyethylene
Titanium 'Sponge Powder'
Hydroxyapatite Ceramic (H-A.C.)
Quantitative material information as per the referenced standards is provided within the section 'Quantitative
Material Information'.
Caution: Contains Cobalt (VAIOS® CoCr Humeral Stems, VAIOS® Anatomic Humeral Heads, VAIOS® Reverse
Glenoid Dome)
Cobalt is classified as a carcinogenic, mutagenic or reprotoxic (CMR) substance and could result in an undesired
biological reaction. Risks resulting from the presence of cobalt in this device have been duly assessed and
minimised as far as possible.
Intended Use
VAIOS® Shoulder System comprises a stemmed hemiarthroplasty system designed for use in partial shoulder
arthroplasty, and a reverse shoulder system for use in primary or revision reverse total shoulder arthroplasty.
Expected Clinical Benefit
The expected clinical benefit of the VAIOS® Shoulder System when used according to instructions for use and the
operative technique is to relieve pain and restore normal biomechanical function and strength of the affected
glenohumeral joint.
Performance Characteristics
The VAIOS
® Shoulder System when used according to instructions for use, labelling and the operative technique
replaces the damaged shoulder joint articulation (fully in reverse total arthroplasty & partially in
hemiarthroplasty) to relieve pain and help restore normal biomechanical function and strength of the affected
glenohumeral joint. The components of the VAIOS® Shoulder System are available in various sizes to
accommodate for variations in patient anatomy.
Treatment Population
VAIOS® Shoulder System is designed for use in skeletally mature individuals where there is sufficient bone stock
to support implantation and fixation of the device.
Description
VAIOS® Shoulder System is a modular system designed for use as either a total reverse shoulder system or a
shoulder hemiarthroplasty.
IFU 155-032 (Issue 13)
March 2023
VAIOS® Shoulder System
English
Page 3 of 146
Chemical Formula /
Abbreviation
Ti Al V
6 4
CoCr
UHMWPE
Ti
Ca (PO ) (OH)
10 4 6 2
Standards
ISO 5832-3
ISO 5832-4, -12
ISO 5834-1, -2
ASTM F1580
ISO 13179-1
ISO 13779-2, -3, -6