Hip System - India CDSCO Medical Device Registration

Product Information

TOTAL HIP PROSTHESIS Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions: 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head or neck. 4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. 5. Certain cases of ankylosis. Porocoat® Porous Coated Components Porocoat® porous coated femoral hip stem and metal backed acetabular cup total hip components are indicated for cementless use with fixation provided by biological tissue ingrowth into the porous coating or for cemented use in which the porous coating serves as a means to augment the fixation of the prosthesis to the bone cement. Cemented Components Femoral stem and acetabular cup total hip components labeled "For cemented use only" are indicated only for use with bone cement. Non-Porous Coated Press Fit or Cemented Components Non-porous coated femoral hip stem prostheses labeled "For press fit or cemented use only" are indicated for press fit uncemented use or for use with bone cement. Ceramic Coated Femoral Components Ceramic coated femoral stem prostheses are indicated for uncemented press fit fixation. CAUTION: DO NOT USE BONE CEMENT FOR FIXATION OF A CERAMIC COATED PROSTHESIS. Modular Femoral Heads and Acetabular Components A DePuy metal or ceramic modular femoral head is to be used with the DePuy femoral stem component. The acetabulum is to be replaced with a DePuy acetabular component comprising either an all UHMWPE cup or 2 piece metal shell with either an UHMWPE, metal or ceramic liner with an inside diameter corresponding to the outside diameter of the modular femoral that is utilized