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The Ultima Total Hip System - Cemented Calcar Replacement Femoral Stem is indicated for use in total, partial, or revision hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint form rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, traumatic femoral fractures, and nonunion of femoral fractures. Use of the prothesis is also indicated for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion, where bone stock is inadequate for other reconstructive techniques.

The Ultima Cemented Calcar Replacement Stem is indicated for use only with PMMA bone cement.

The Ultima calcar replacement stem is a cemented femoral component for use in total or partial hip arthroplasty procedures. The stems are available in standard and long lengths. The standard length size range includes 3 base stem sizes, each available in 3 body lengths. The 3 base sizes are also each available in right and left long stem components; which are anatomically bowed. Also, the stems are available in 2 trunnion taper designs, i.e., 10/12 and 12/14.

The stem body design is derived from that of the primary Ultima stems #K924379. The proximal body of the Ultima cemented calcar stem, below the horizontal flange, is identical to that of the primary Ultima stems of equivalent size.

The Ultima calcar replacement stem features a vertical and horizontal flange, the former to provide support for the deficient or fractured greater trochanter and the latter to anatomically cap the resected calcar surface. The vertical flange has grooves located along it's anterior and posterior edges to provide a constraint in cases where cables/wires are used. The lateral face of the vertical flange features a macrotextured surface finish to provide some resistance to movement of the greater trochanter against the lateral flange.

A 2-lobed A/P hole is provided proximal to the horizontal flange to enabling passing a cable/wire through the stem when it is necessary to anchor the greater trochanter and/or a proximal bony fragment to the stem. The medial aspect of the stem immediately proximal to the horizontal flange features a gentle radius to enable cabling/wiring around the stem if necessitated.

The distal aspect of the standard length stems are fluted to provide resistance to rotational movement of the standard length stems also feature a distal hole to accept an optional PMMA distal centralizer component. The long stems are anatomically bowed to pass the isthmus and thereby bypass actual or potential bony defects.

This is a premarket notification (510(k)) for a medical device, not a study evaluating AI or software performance. Therefore, the requested information about acceptance criteria, study design, sample sizes, expert ground truth, and AI-related metrics (MRMC, standalone performance, training data) is not applicable to this document.

This submission focuses on demonstrating substantial equivalence to previously cleared devices based on physical description, materials, intended use, design, manufacturing, packaging, and sterilization methods. It does not contain any performance data from clinical studies or algorithm evaluations in the context of the questions provided.

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