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The Calcar Replacement Hip Stem is intended for use in treatment of intertrochanteric, comminuted, or femoral neck fracture; trochanteric non-union; erosion of calcar or femoral neck, and; revision total hip arthroplasty involving bone loss in the proximal femur or tumors. In addition, the Calcar Replacement Hip Stem like the predicate IOI and competitive hip stems is intended for cemented application in cases of total hip arthroplasty.

• 1. Patient conditions of intertrochanteric, comminuted or femoral neck fracture
• 2. Trochanteric nonunion
• 3. Erosion of the calcar or femoral neck
• 4. Revision total hip arthroplasty involving bone loss in the proximal femur
• 5. Tumors.

The Calcar Replacement Hip Stem employs a Sulzer 12/14 configured threaded trunnion for attachment to the IOI's femoral heads, including Biolox and Zirconia ceramic heads, featuring a Sulzer 12/14 configured threaded bore. The Biolox and Zirconia ceramic heads are available in two sizes, 28mm inner diameter (ID), and 32mm ID. The Biolox and ceramic bearing heads have been determined substantially equivalent by the FDA via 510(k) #'s K923934 and K942330.
The proximal body of the hip stem features an extraction hole in the anterior/posterior direction to facilitate removal of the hip stern if revision becomes necessary. The proximal body of the hip stem features a sloted flange which allows the surgeon the option of wiring the trochanter. The Calcar Replacement Hip Stem employs a keel below the proximal-medial flange for enhanced rotational stability.
The grit blasted distal portion of the hip stem employs two medial longitudinal grooves and is oval shaped. The grit blasted surfaces provide enhanced interdigitation with bone cement. The Calcar Replacement Hip Stem is available with a distal hole for optional use with the PMMA canal centralizer.

This document pertains to the 510(k) Premarket Notification for the Calcar Replacement Hip Stem, a medical device, and therefore does not contain information about software acceptance criteria or studies involving AI/ML performance.

The provided text describes the device's technical characteristics and its intended use, along with a comparison to predicate devices. It does not include any information related to:

• Acceptance criteria for software performance
• Studies proving device meets acceptance criteria related to software
• Sample sizes for test or training sets
• Data provenance
• Number or qualifications of experts for ground truth
• Adjudication methods
• Multi-reader multi-case (MRMC) comparative effectiveness studies
• Standalone algorithm performance studies
• Type of ground truth used
• How ground truth for a training set was established

The document is a traditional medical device submission, focusing on substantial equivalence to previously cleared devices based on physical design, materials, and intended use, rather than software performance.

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