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The Revival™ Modular Hip Stem is indicated in revision surgery of femoral components, following failure of a primary cemented prosthesis. The Revival™ Modular Hip Stem 100mm distal component is also indicated in primary total hip arthroplasty.

The indications for the Revival™ Modular Hip Stem include:

• . Non-inflammatory degenerative joint disease including primary and secondary osteoarthritis and hip dysplasia
• Aseptic necrosis of the femoral head ●
• Rheumatoid arthritis
• Correction of functional deformity ●
• Treatment of non-union and femoral neck fractures ●
• Treatment of traumatic dislocations of the hip .
• Failures of osteotomy ●
• Treatment of arthrodesis .

The Revival™ Modular Hip Stem is indicated for cementless, single use only.

The Revival™ Modular Hip Stem is a modular stem manufactured from titanium alloy (Ti6Al4V ELI) with a proximal component, a distal component and a locking screw. The modular proximal component is available in four lengths (40, 50, 60, and 70mm) and two CCD angles (125° and 135°). The distal component is conical in shape and has longitudinal fins. The distal component design has four lengths (100, 160, 200, and 240mm) and ten diameters (14, 15, 16, 17, 18, 19, 20, 21, 22, and 24mm). The proximal and distal components are assembled using a 'Morse' taper 2 '51' so that the proximal component can be dialed into position to achieve the anteversion required. The locking screw is used to assemble and hold the 'Morse' taper cone in place. The Revival stem has a surface finish obtained by abrasion with corundum to increase the contact surface for cementless fixation. The device is intended to be used with Corin (12/14 taper) modular heads.

The Revival™ Modular Stem was originally cleared in K152903. This submission is being made to modify the indications for use to include a primary indication and to include additional sizes to the range.

This document is a 510(k) premarket notification for a hip joint prosthesis, not an AI/ML medical device. Therefore, the information requested about acceptance criteria, study design, ground truth, and human reader performance is not applicable to this document.

The document discusses the substantial equivalence of the Revival™ Modular Hip Stem to previously cleared predicate devices. The review focuses on its design, materials, indications for use, and non-clinical testing (mechanical fatigue, static, torque, and range of motion testing; FEA; and bacterial endotoxin testing).

The relevant sections explicitly state:

• "Non-clinical testing and analysis included FEA, mechanical fatigue testing, static testing, torque testing, and range of motion testing." (Page 5, Section 13)
• "Clinical testing was not necessary in this Traditional 510(k) to determine substantial equivalence between the additional components of the Revival™ Modular Hip Stem and the predicate devices." (Page 5, Section 14)

Since this document does not describe a study involving AI/ML performance, human readers, or image analysis, I cannot provide the details requested in the prompt regarding AI/ML device testing.

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