Instrument System for Total Hip System - India CDSCO Medical Device Registration

Product Information

Medical Device—Instrument system for Total Hip System Intended use -- The instrument system for Total Hip System is used in surgical procedure for Total Hip Replacement The instrument system for Total Hip System used in surgical procedure includes –acetabulum exposure with retractor /lever with or without cement preparation and femoral preparation with or without cement usage. Surgical instrumentation used in surgical procedure starts with reaming of acetabular cavity and decision of cemented or cementless acetabular cup implantation followed by trials for temporary sizing guide to check the size and fit of orthopaedic implants before actual implantation of the device as THR cup trials for cemented application or shell-liner trials for cementless application. THR Cup or shell -liner trials always assembled with Femoral head trials for checking offset and leg length. Cemented reamers 2 size bigger than implant for provision of cement mantle while cementless reamers 2 size smaller than implant for press fit application. Acetabular cup holder decides 45degree position in cemented cup while anteversion handle indicates position of the shell with respective acetabular cavity. Cementless shell can be fixed with flexible shaft and tips for drill-screw driver at angle with screws in acetabulum cavity. 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 shell-liner and femoral head followed by impact with impactor