CDSCO UID IMP/MD/2019/000489_adb7df7fd4f0b21b824d6830621ac1cc_0b11bec26c9295e8adc10c5df2336c29

Shoulder System

Johnson & Johnson Private Limited·Device Class Class D·India CDSCO·Brand: Global Advantage - Head

Registration details

UID: IMP/MD/2019/000489_adb7df7fd4f0b21b824d6830621ac1cc_0b11bec26c9295e8adc10c5df2336c29
Device class: Class D
Brand name: Global Advantage - Head
License holder: Johnson & Johnson Private Limited
Approving authority: CDSCO
Product information: GLOBAL ADVANTAGE® and GLOBAL AP™ Shoulder Systems The DePuy GLOBAL ADVANTAGE and GLOBAL AP Shoulder Systems are indicated for use in total or hemi-shoulder replacement for the treatment of: 1. A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis; 2. Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon’s experience indicates that alternative methods of treatment are unsatisfactory; 3. Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (Global Advantage - Head). The DePuy GLOBAL ADVANTAGE, and GLOBAL AP Shoulder Systems are also indicated for hemi-shoulder replacement for the treatment of: 1. Ununited humeral head fractures; 2. Avascular necrosis of the humeral head. GLOBAL ADVANTAGE and GLOBAL AP™ CTA Humeral Heads The DePuy GLOBAL ADVANTAGE and GLOBAL AP CTA Humeral Heads are indicated only for hemi-shoulder replacement in patients with rotator cuff tears. The DePuy GLOBAL ADVANTAGE CTA Humeral Heads can be used with the GLOBAL FX and GLOBAL ADVANTAGE Humeral Stems and the GLOBAL AP CTA Humeral Head can be used with the GLOBAL AP Humeral Stem in hemi-shoulder replacement in patients with rotator cuff tears. GLOBAL FX, GLOBAL ADVANTAGE and GLOBAL AP™ Shoulder Systems Fixation Methods The DePuy GLOBAL FX, GLOBAL ADVANTAGE, and GLOBAL AP Shoulder Systems are indicated for the following fixation methods: • POROCOAT™ Porous-Coated Components - Porocoat porous-coated humeral stem prostheses are indicated for cemented or uncemented use with fixation provided by biological tissue ingrowth into the porous coating. • Cemented Components - Humeral Stem and Glenoid components labeled “For cemented use only” are indicated only for use with bone cement. • Press-fit or Cemented Components - Humeral stem prostheses without porous coating and labeled “For press-fit or cemented use only” are indicated for press-fit uncemented use or for use with bone cement