CDSCO UID IMP/MD/2019/000029_22a18215ebfdb806ed7b0905365e475f_bafe2a5db9af3f3436ecd5922e4d0667
Shoulder Replacement System
Johnson & Johnson Private Limited·Device Class Class D·India CDSCO·Brand: LPS
Registration details
- UID
- IMP/MD/2019/000029_22a18215ebfdb806ed7b0905365e475f_bafe2a5db9af3f3436ecd5922e4d0667
- Device class
- Class D
- Brand name
- LPS
- License holder
- Johnson & Johnson Private Limited
- Approving authority
- CDSCO
- Product information
- 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 (LPS). 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. 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. 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
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About this record
Shoulder Replacement System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000029_22a18215ebfdb806ed7b0905365e475f_bafe2a5db9af3f3436ecd5922e4d0667. This device is marketed under the brand name LPS. The license holder is Johnson & Johnson Private Limited, and it is classified as Device Class Class D. The approving authority is CDSCO.
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