Instrument System for Total Knee System - India CDSCO Medical Device Registration
Instrument System for Total Knee System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2023/000266_3ae5fcdefcb8ee0aa8da4d445c4e5890_554fba30701a305d0769008cddc9b8ad. The license holder is RCH ORTHOPAEDICS, and it is classified as Device Class Class B. The approving authority is Kokan Division.
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License Holder
RCH ORTHOPAEDICSDevice Class
Approving Authority
Kokan Division
Product Information
The instrument system for Total Knee Replacement System is used in surgical procedure for Total Knee Replacement Rejoy Cemented PS Instruments were designed to address the requirements of all Total Knee Arthroplasty procedures. Preparation may be initiated at either the femur or the tibia. Spacer blocks are provided for extension and flexion gap evaluation. Patellar instrumentation is available for compatible preparation of patella resurfacing. The instrument system for Total Knee replacement System used in surgical procedure includes –knee joint exposure with retractor /lever with or without cement preparation Femoral component and Tibial preparation with or without cement usage. Surgical instrumentation used in surgical procedure starts with knee joint exposure by distal femoral resection followed by proximal tibia resection results in assessment of extension gap and assessment of flexion gap or femoral resection move towards preparation of ps box and tibia stem preparation .Trial reduction and functional test with trials followed by implantation
