Hip system- Stem - India CDSCO Medical Device Registration

Hip system- Stem is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000172_b06c34363950c72ce3c984db515bb1aa_bdea481cabee681124388bc56b806cdd. This device is marketed under the brand name Marathon XLPE. 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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CDSCO Registered

Class Class D

Hip system- Stem

UID: IMP/MD/2019/000172_b06c34363950c72ce3c984db515bb1aa_bdea481cabee681124388bc56b806cdd

Brand Name

Marathon XLPE

License Holder

Johnson & Johnson Private Limited

Device Class

Class D

Approving Authority

CDSCO

Product Information

This stem is indicated only for use with bone cement. 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.

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Hip replacement System- Head

Brand: Marathon XLPE

Johnson & Johnson Private Limited

Hip system- Stem - India CDSCO Medical Device Registration

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Approving Authority

Product Information

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