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The GMK HINGE knee prosthesis is designed for cemented use in total knee arthroplasty when the preoperative diagnosis of the joint determines that the bone and stability situation require the implantation of a constrained prosthesis.

The GMK HINGE knee system is indicated in the following cases:

· Severely painful and/or disabled joint as a result of arthritis, theumatoid arthritis or polyarthritis associated with bone loss and/or severe joint instability

• · Considerable loss of function of the knee joint
  · High-grade joint destruction requiring additional stabilization with stems and reconstruction of bone defects with metal augmentation

• · Failure of a primary prosthesis (e.g. infection, loosening)

• · Former revision arthroplasty

• Post traumatic loss of joint configuration

• · Avascular necrosis of femoral condyle

Tibial augmentations are to be screwed to the tibial baseplate with both of the two provided fixing screws.

When a GMK HINGE implant is used it is mandatory to implant both the femoral and tibial components with an extension stem.

The Evolis/GMK knee prosthesis is designed for cemented use in total knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components.

This knee replacement system is indicated in the following cases:

• · Severely painful and/or disabled joint as a result of arthritis, traumatoid arthritis, or polyarthritis
• · Avascular necrosis of femoral condyle
• Post traumatic loss of joint configuration
• · Primary implantation failure

Tibial wedges cemented are to be attached to the tibial baseplate with both the fixing cylinders and bone cement.

The screwed tibial augments are for screwed fixation to the tibial baseplate.

In case a semi-constrained liner is used, an extension stem must be implanted both on the tibial and on the femoral components.

In case a GMK Revision tibial tray is used, an extension stem must be implanted.

GMK Hinge:

This extension to the GMK Hinge product family consists of screwed tibial augmentations (thicknesses 15 and 20 mm) and Ultra Congruent (UC) fixed tibial inserts.

The tibial augmentations allow the surgeon to selectively fill bone deficiencies and to aid in restoring the joint line. The fixation between the augmentations and the tibial tray is assured by a screw fixation. The screwed tibial augmentations are manufactured from High Nitrogen Stainless Steel M30NW (ISO 5832-9). The tibial augmentation connection screws are manufactured from titanium alloy (Ti6Al4V; ISO 5832-3).

The UC fixed tibial insert is fixed to the tibial component through a screw and is designed to provide high rotational control and a high varus/valgus constraint. The UC fixed tibial inserts are manufactured from type 1 Ultra High Molecular Weight Polyethylene (UHMWPE; ISO 5834-2) and Cobalt-Chromium-Molybdenum alloy (CoCrMo; ISO 5832-12). The fixation screws are manufactured from titanium alloy (Ti6A14V; ISO 5832-3).

GMK Revision:

This extension to the GMK Revision product family adds additional screwed tibial augmentations (thicknesses 15 and 20 mm) to the GMK Revision extension cleared under K123721. The tibial augments allow the surgeon to selectively fill bone deficiencies and to aid in restoring the joint line. The fixation between the augmentations and the tibial tray is assured by a screw fixation. The screwed tibial augmentations are manufactured from High Nitrogen Stainless Steel M30NW (ISO 5832-9). The tibial augmentation connection screws are manufactured from titanium alloy (Ti6Al4V; ISO 5832-3).

I am sorry, but the provided text is a 510(k) premarket notification for a medical device (knee prosthesis). It describes the device, its indications for use, and a comparison to predicate devices, along with a list of non-clinical performance data.

However, it does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of an AI/ML powered device. The document is purely for a traditional medical device (knee implants) and does not mention any AI components, ground truth, expert adjudication, or MRMC studies.

Therefore, I cannot extract the requested information from this document.

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