Instrument System for Bipolar Hip System - India CDSCO Medical Device Registration
Instrument System for Bipolar Hip System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2022/000678_421c7405a79815c510de4779accc542d_5270e1141a30ffb7d5ad08686bfb9535. The license holder is RCH ORTHOPAEDICS, and it is classified as Device Class Class A. 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 bipolar Hip System used in surgical procedure includes โacetabulum exposure with retractor /lever and femoral preparation with or without cement usage. Surgical instrumentation used in surgical procedure starts with cutting of head and extracting with head extractor followed by measurement of Femoral head after neck cut with head gauge followed by trials for temporary sizing guide to check the size and fit of orthopaedic implants before actual implantation of the device as bipolar shell trials. Bipolar shell trials always assembled with Femoral head trials for checking offset. Femoral preparation instrumentation used in surgical procedure starts with neck cut guide followed by lateral rasp-box chisel and femoral canal reamer before placement of broach/rasp assembled with handle for cemented /uncemented femoral stem design. Rasp always assembled with taper cap or neck for the implant stem offset. Cap or neck provides seating for Femoral head trials to check offset and leg length during trial reduction in case of trial cum rasp assembly or with trial and femoral head if trials provided separately. Femoral canal cement restricted with restrictor introduced with cemented restrictor handle scaled for the length for cemented application. Trailing followed by stem inserter and stem inserter cum extractor anteversion handle followed by femoral head sizing. Placement of implants need assembly of bipolar shell and femoral head with vice followed by impact with impactor

