Total Knee System - India CDSCO Medical Device Registration

Total Knee System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2022/000052_ed840676bf82becf25e74dd89cf95c2e_91ff2df3072b504ad062521e1b50e733. This device is marketed under the brand name Consensus Knee System/ Revision Knee System/ Consensus MBK System/ TUKS Knee System. The license holder is MARS MEDICAL DEVICES LIMITED, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

Total Knee System

UID: IMP/MD/2022/000052_ed840676bf82becf25e74dd89cf95c2e_91ff2df3072b504ad062521e1b50e733

Brand Name

Consensus Knee System/ Revision Knee System/ Consensus MBK System/ TUKS Knee System

License Holder

MARS MEDICAL DEVICES LIMITED

Device Class

Class C

Approving Authority

CDSCO

Product Information

a) Primary intervention of rheumatoid arthritis, osteoarthritis, traumatic arthritis, degenerative arthritis, polyarthritis, collagen disorders, and/or avascular necrosis of the femoral condyle. b) Post-traumatic loss of joint configuration (Consensus Knee System/ Revision Knee System/ Consensus MBK System/ TUKS Knee System). c) Failed osteotomy or unicompartmental replacements. d) Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists. e) The salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery. f) Moderate valgus, varus, or flexion deformities. g) TUKS is indicated for Primary medial or lateral compartmental intervention of (Consensus Knee System/ Revision Knee System/ Consensus MBK System/ TUKS Knee System) primary non-inflammatory degenerative disease, including osteoarthritis, traumatic arthritis or osteonecrosis; (Consensus Knee System/ Revision Knee System/ Consensus MBK System/ TUKS Knee System) post-traumatic degenerative disease; (Consensus Knee System/ Revision Knee System/ Consensus MBK System/ TUKS Knee System) varus or valgus deformities; and (Consensus Knee System/ Revision Knee System/ Consensus MBK System/ TUKS Knee System) damage due to previous surgical intervention when the opposite compartment is preserved and when the anterior cruciate, posterior cruciate, medial collateral, and lateral collateral ligaments are present and functional.