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• Primary intervention of rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, A. collagen disorders, and/or avascular necrosis of the femoral condyle.
• Post-traumatic loss of joint configuration (particularly when there is patellofemoral erosion, B. dysfunction, or prior patellectomy).
• Failed osteotomy or unicompartmental replacements. C.
• Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone D. stock exists.
• The salvage of previously failed surgical attempts if the knee can be satisfactorily balanced E. and stabilized at the time of surgery.
• Moderate valgus, varus, or flexion deformities. F.

All MRKS femoral components and tibial baseplates are intended for cemented use only: All MRKS stems are intended uncemented use.

The MILESTONE Revision Knee System (MRKS) is a semi-constrained, cemented knee prosthesis designed for either primary or revision total knee arthroplasty. The MRKS contains left and right configurations of a femoral component and a fixed-bearing tibial component, in addition to accessory components including stems, augments, screws, pegs, a taper plug, and a baseplate plug. The femoral component and tibial baseplate employ modularity for stem and augment attachment.

The MRKS femoral component is manufactured from cast cobalt chrome alloy. It is offered in six sizes (1-6) and is designed to articulate with the MRKS ultracongruent tibial insert and the MILESTONE Knee System (MKS) all poly patellar component (K112285). The MRKS femoral component is not designed to articulate with the MKS posterior stabilizing (PS) tibial insert (K112285) or any condylar constrained tibial components. The MRKS box profile is thicker than the MKS femoral component to accommodate increased bone loss.

The MRKS tibial component consists of two parts to be assembled at the time of surgery: a tibial baseplate and an ultracongruent (PCL substituting) tibial insert. The baseplate is manufactured from cast cobalt chrome alloy and is designed with an identical locking mechanism as the MKS tibial baseplate (K112285). The baseplate is offered in seven sizes (0-6) and is designed to accommodate the MRKS ultracongruent insert when used with the MRKS femoral component or the MKS PS tibial insert (K112285) when used with the MKS PS femoral component (Ki 12285). The MRKS tibial baseplate is thicker than the MKS baseplate to accommodate increased bone loss. The MRKS insert is manufactured from ultra-high molecular weight polyethylene (UHMWPE) and is designed with an identical locking mechanism, thickness, and size range as the MKS PS insert.

The MRKS accessory components are manufactured from Titanium alloy. The stems are available in three lengths (80, 110, and 150mm) and seven diameters (10-22mm). They employ a male 12/14 Morse taper for attachment to the CRKS femoral component or tibial baseplate. The taper plug is available in one size and is intended for use when a stem is not desired. The taper plug employs an identical male taper as the stem. The augments are available in left and right configurations, and are offered in a range of sizes to accommodate all sizes of the MRKS femoral components and tibial baseplates. Femoral augments are split into distal and posterior segments, each available in 5mm thicknesses. Tibial augments are available in 5mm and 10mm thicknesses. The pegs are offered in three sizes (short, medium, and long). Screws are offered in two sizes (short and long). The baseplate plug is offered in one size. The pegs and screws are designed for mechanically attaching the augments to their respective implants. Pegs also aid in stabilizing the implant post-operatively and are designed to fill the distal augments holes of the femoral component and augment holes of the tibial baseplate when augments are not desired. The baseplate plug is designed to fill the baseplate augment holes when pegs and augments are not desired.

This document is a 510(k) summary for a medical device called the "MILESTONE Revision Knee System (MRKS)", a revision knee prosthesis. It details the device description, indications for use, and a claim of substantial equivalence to predicate devices. Crucially, the provided text does NOT contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way typically found for AI/ML-driven medical devices.

Instead, this document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, which is the regulatory pathway taken for this type of medical implant.

Therefore, I cannot populate the requested table and answer the study-related questions as those details are not present in the provided text. The document states:

"Because the MRKS components employ identical geometry and material characteristics as those employed by their respective predicate CRKS and CKS components, non-clinical bench testing and analyses were provided for these predicate components to validate the safety and effectiveness of the MRKS. No further testing on MRKS components was necessary."

This indicates that instead of new performance studies with specific acceptance criteria, the device relies on the established safety and effectiveness of its predicate devices through the substantial equivalence pathway.

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