TOTAL KNEE REPLACEMENT - TIBIAL & FEMORAL COMPONENT - India CDSCO Medical Device Registration

TOTAL KNEE REPLACEMENT - TIBIAL & FEMORAL COMPONENT is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2019/000196_49fc1e770716429c1dd87b38415dde82_e4bc572515d656fb76d25c976e7f9836. This device is marketed under the brand name SHARMA, SPCPL, DKSORTHO, DKSORTHO MEDICAL DEVICES. The license holder is DKSORTHO & SHARMA PHARMACEUTICAL PRIVATE LIMITED, and it is classified as Device Class Class C. The approving authority is Central Drug Standards Control Organization, Ahmedabad.

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CDSCO Registered

Class Class C

TOTAL KNEE REPLACEMENT - TIBIAL & FEMORAL COMPONENT

UID: MFG/MD/2019/000196_49fc1e770716429c1dd87b38415dde82_e4bc572515d656fb76d25c976e7f9836

Brand Name

SHARMA, SPCPL, DKSORTHO, DKSORTHO MEDICAL DEVICES

License Holder

DKSORTHO & SHARMA PHARMACEUTICAL PRIVATE LIMITED

Device Class

Class C

Approving Authority

Central Drug Standards Control Organization, Ahmedabad

Product Information

TOTAL KNEE REPLACEMENT (SHARMA, SPCPL, DKSORTHO, DKSORTHO MEDICAL DEVICES) IS INTENDED TO PROVIDE INCREASED PATIENT MOBILITY AND REDUCE PAIN BY REPLACING THE DAMAGED KNEE JOINT ARTICULATION INPATIENTS WHERE THERE IS EVIDENCE OF SUFFICIENT SOUND BONE TO SEAT AND SUPPORT THE COMPONENTS. TKR MAY BE CONSIDERED FOR YOUNGER PATIENTS IF, IN THE OPINION OF THE SURGEON, AN UNEQUIVOCAL INDICATION FOR TKR OUTWEIGHS THE RISKS ASSOCIATED WITH THE AGE OF THE PATIENT, AND IF LIMITED DEMANDS REGARDING ACTIVITY AND KNEE JOINT LOADING CAN BE ASSURED. THIS INCLUDES SEVERELY CRIPPLED PATIENTS WITH MULTIPLE JOINT INVOLVEMENT FOR WHOM AGAIN IN KNEE MOBILITY MAY LEAD TO AN EXPECTATION OF SIGNIFICANT IMPROVEMENT IN THE QUALITY OF THEIR LIVES. TKR IS INDICATED FOR A SEVERELY PAINFUL AND/OR DISABLED JOINT FROM OSTEOARTHRITIS, POST-TRAUMATIC ARTHRITIS, RHEUMATOID ARTHRITIS OR A FAILED PREVIOUS IMPLANT