TOTAL KNEE REPLACEMENT SYSTEM - India CDSCO Medical Device Registration
TOTAL KNEE REPLACEMENT SYSTEM is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2023/000077_70096ae85245e535caaf0d802f555c4a_327c8d4aa820e1fb3fbf955ff3bdc4fd. This device is marketed under the brand name ACTIKNEE, NEXWAY, KNEEWISE. The license holder is BOMBAY ORTHO INDUSTRIES PRIVATE LIMITED, and it is classified as Device Class Class C. The approving authority is Central Drug Standards Control Organization, Ahmedabad.
This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.
Brand Name
ACTIKNEE, NEXWAY, KNEEWISE
License Holder
BOMBAY ORTHO INDUSTRIES PRIVATE LIMITEDDevice Class
Approving Authority
Central Drug Standards Control Organization, Ahmedabad
Product Information
The Total Knee System is indicated for replacement of knee or knee components for patients suffer from severe knee pain and disability due to: • Degenerative knee joint disease: rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis; • Correction of functional deformities; • Post-traumatic loss of knee joint contour; • Moderate valgus, varus, or flexion trauma; • Knee fractures untreatable by other methods.
