Shoulder System - India CDSCO Medical Device Registration

Product Information

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Revision where other devices or treatments have failed. 4. Correction of functional deformity. 5. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate. 6. Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate. Humeral components with a MacroBond™ surface coating are indicated for either cemented or uncemented press-fit applications. Humeral/glenoid components with a porous coated surface coating are indicated for either cemented or uncemented biological fixation applications. (Vanguard Knee System - tibial Component). Glenoid components with Hydroxyapatite (Vanguard Knee System - tibial Component) coating applied over the porous coating are indicated only for uncemented biological fixation applications. (Vanguard Knee System - tibial Component). Humeral components with a non-coated (Vanguard Knee System - tibial Component) surface are indicated for cemented application only. Polyethylene glenoid components not attached to a metal back are indicated for cemented application only. The Comprehensive™ Modular Hybrid Glenoid is intended to be implanted with bone cement. The optional porous titanium peg may be inserted without bone cement. The optional polyethylene peg should be inserted with bone cement. The Comprehensive™ Humeral Positioning Sleeves are for cemented use only and are intended for use with the Comprehensive™ Fracture Stem. The Comprehensive™ Shoulder Stems (Vanguard Knee System - tibial Component) are intended for use with the Bio-Modular™ Humeral Heads and glenoid components and Versa-Dial™ Humeral Heads. The Versa-Dial™ Humeral Head Prosthesis is intended for use only with the Comprehensive™ Shoulder Stems (Vanguard Knee System - tibial Component), the Bio- Modular™ Shoulder Stems, the glenoid components of the Bio-Modular™ Shoulder System, and the glenoid components of the Comprehensive™ Shoulder System. In addition to those specified above, the Proximal Shoulder Replacement prostheses are indicated for use in oncology applications, complex humeral fractures and revisions. When a humeral stem and/or Versa-Dial™ Taper Adapter is being used for areverse shoulder application, the user should refer to the package insert (Vanguard Knee System - tibial Component) continued with the reverse shoulder components for additional information, including alternate indications