Instrument system for Total Shoulder Replacement system - India CDSCO Medical Device Registration

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The goal of total shoulder replacement surgery is to relieve shoulder pain and increase shoulder function by resurfacing the bones that meet at the shoulder's ball-and-socket joint, or glenohumeral joint. The surgeon removes the humeral head at the top of the arm bone ##PLACEHOLDER_0##, reshapes the shoulder socket ##PLACEHOLDER_0##, and attaches prosthetic components to both bones. The instrument system for Total Shoulder System used in surgical procedure includes –glenohumeral joint exposure with retractor /lever with or without cement preparation and humeral preparation with or without cement usage. Surgical instrumentation used in surgical procedure starts with reaming of glenohumeral cavity and decision of cemented or cementless glenoid implantation followed by trials for temporary sizing guide to check the size and fit of orthopaedic implants before actual implantation of the device as glenohumeral cup trials for cemented application or glenohumeral shell -liner trials for cementless application. Glenohumeral -liner trials always assembled with humeral head trials for checking offset and range of motion. Total shoulder replacement ##PLACEHOLDER_0## Sometimes called traditional shoulder replacement or traditional shoulder arthroplasty, this surgery replaces the original ball-and-socket surfaces of the shoulder with similarly shaped prosthetics. Total shoulder replacement is considered the most reliable surgical option for relieving debilitating shoulder arthritis, but it is not appropriate for people who want to remain very active or have damaged rotator cuff muscles. Reverse shoulder replacement ##PLACEHOLDER_0## During reverse shoulder replacement the surgeon switches, or reverses, the positions of the shoulder joint's ball and socket. The ball at the top of the humerus ##PLACEHOLDER_0## is replaced with a socket-shaped prosthetic, while the shoulder's natural socket is fitted with a prosthetic ball. This surgery is an option for people whose damaged rotator cuffs make them ineligible for traditional shoulder replacement. It changes the center of rotation of the joint, enabling other muscles to compensate for a lack of rotator cuff function. Partial shoulder replacement ##PLACEHOLDER_0## During a partial shoulder replacement, or shoulder hemiarthroplasty, the arm's humeral head is removed and replaced with a prosthetic ball but the natural socket, or glenoid bone, is kept. Ream and run. During this version of a partial shoulder replacement surgery, the natural socket is kept; however, the surgeon might use special tools to smooth and reshape this socket to facilitate better shoulder joint movement. This process is called a hemiarthroplasty with non-prosthetic glenoid arthroplasty or, more informally, "ream and run." Shoulder Resurfacing ##PLACEHOLDER_0## During this surgery the damaged humeral head is fitted with a smooth rounded cap to facilitate better joint movement. Unlike a stemmed hemiarthroplasty, shoulder resurfacing does not require the complete removal of the natural humeral head nor the insertion of a prosthetic humeral stem. Humeral preparation instrumentation used in surgical procedure starts with humeral head neck cut guide followed by humeral 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 Humeral head trials to check offset and range of motion during trial reduction in case of trial cum rasp assembly or with trial and humeral head if trials provided separately. Humeral 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 forceps/ anteversion handle followed by humeral head sizing. Placement of implants need assembly of glenohumeral-liner and humeral head followed by impact with impactor