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CDSCO UID IMP/MD/2021/000401_fe2aab42d294ab713b1f6619411cb39d_dc24c50f4a2d950a82933ed5a526d787

Hip System

Johnson & Johnson Private Limited·Device Class Class D·India CDSCO·Brand: Biolox Delta- Revision Heads
Registration details
UID
IMP/MD/2021/000401_fe2aab42d294ab713b1f6619411cb39d_dc24c50f4a2d950a82933ed5a526d787
Device class
Class D
Brand name
Biolox Delta- Revision Heads
License holder
Johnson & Johnson Private Limited
Approving authority
CDSCO
Product information
BIOLOX delta TS Ceramic Femoral Head 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. The taper sleeved ceramic head hip assembly is intended for hip replacement surgery and cases of failed femoral hip head and/or acetabular components, with the presence of a well-fixed femoral stem. Intended Use: The DePuy BIOLOX delta TS Ceramic Femoral Head is intended for use in total hip arthroplasty applications to replace the articular surface of the femoral head in primary hip surgery and for the salvage of a failed previous hip surgery. Indications: The DePuy BIOLOX delta TS Ceramic Femoral Head is indicated for use as the femoral head component in total hip arthroplasty procedures. 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. Modular Femoral Heads and Acetabular Components A DePuy BIOLOX delta TS ceramic femoral head is to be used with a DePuy femoral stem component. The acetabulum is to be replaced with a DePuy two-piece metal backed UHMWPE, or ceramic cup or all UHMWPE acetabular cup component with an inside diameter that matches the outside diameter of the modular femoral head that is utilized
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About this record

Hip System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000401_fe2aab42d294ab713b1f6619411cb39d_dc24c50f4a2d950a82933ed5a526d787. This device is marketed under the brand name Biolox Delta- Revision Heads. 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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