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

GMK Sphere/Spherika can be implanted using a kinematic alignment approach. When a kinematic alignment approach is utilized, this knee replacement system is indicated in the following cases:
· Severely painful and/or disabled joint as a result of arthritis, traumatoid arthritis, rheumatoid arthritis.

• · Collagen disorders, and/or avascular necrosis of the femoral condyle.
• · Moderate valgus, varus, or flexion deformities.

The purpose of this submission is to notify the FDA of the GMK SPHERE range Extension, that includes GMK Spherika Femurs and GMK Fixed Tibial Trays Plus.

Subject devices are sterile implantable devices designed for tricompartment of the natural knee joint.

The subject devices are marketed as individually packaged femoral and tibial components, designed for cemented use in total knee arthroplasty procedures.

GMK Spherika femoral component is an implantable device intended to be used in case of total knee arthroplasty to replace the femoral articular surfaces of the knee joint. GMK Spherika femoral component can be used in Kinematic Alignment surgical technique. The Kinematic Alignment surgical technique was already cleared in K173890.

GMK Tibial Trays Plus are a range extension of the GMK Tibial trays already cleared, in details they are fixed intermediate sizes of the tibia trays.

The subject devices are a line extension to Medacta previously cleared implants: GMK Sphere (K121416), GMK Sphere Extension (K140826), GMK Knee Prosthesis- GMK Sphere Tibial Insert Flex (K162035), GMK Sphere - Kinematic Alignment ( K173890), GMK Sphere CR Tibial Inserts (K181635), GMK Sphere E-Cross (K202022), GMK Total Knee System-TiNbN Coating (K202684), Medacta International SA, GMK Total Knee System (K090988), GMK Line Extension (K120790), GMK Narrow K122232, MK Extension (K142069) and

The subject devices are manufactured with the same materials of the previous cleared femurs and tibial trays.

The submission includes the following implants:

• . GMK Spherika Femoral Component Cemented, Left and Right, Sizes from 1 to 7 and from 1+ to 6+ made in Co-Cr-Mo (ISO 5832-4)
• . GMK Spherika Femoral Component Cemented, Left and Right, Sizes from 1 to 7 and from 1+ to 6+ made in Co-Cr-Mo (ISO 5832-4) and TiNbN Coated
• . GMK Spherika Femoral Component Anatomical, Cemented, Left and Right, Sizes from 1 to 7 and from 1+ to 6+ made in Co-Cr-Mo (ISO 5832-4)
• GMK Spherika Femoral Component Anatomical, Left and Right, Sizes from 1 to 7 and . from 1+ to 6+ made in Co-Cr-Mo (ISO 5832-4) and TiNbN Coated
• Tibial tray fixed cemented, Left and Right, Sizes from 1+ to 5+ plus 4 intermediate sizes ● made in Co-Cr-Mo (ISO 5832-4)
• Tibial tray fixed cemented, Left and Right, Sizes from 1+ to 5+ plus 4 intermediate sizes made in Co-Cr-Mo (ISO 5832-4) and TiNbN Coated

The subject devices, both Femoral Components and Tibial Trays, are manufactured from cobaltchromium-molybdenum alloy (Co-Cr-Mo) according to ISO 5832-4:2014 Implants for Surgery -Metallic Materials-Part 4: Cobalt-Chromium-Molybdenum Casting Allov.

In regards to the Femurs and Tibial Trays TiNbN Coating, they are manufactured from cobaltchromium-molybdenum alloy (Co-Cr-Mo) according to ISO 5832-4:2014 Implants for Surgery -Metallic Materials-Part 4: Cobalt-Chromium-Molybdenum Casting Alloy with Titanium Niobium Nitride (TiNbN) coating.

Like the predicate tibial trays devices, the tibial trays plus subject of this submission have a Fixed Tibial Tray Plug that is manufactured from Type 1 Ultra High Molecular Weight Polyethylene (UHMWPE) per ISO 5834-2: 2019 Implants for Surgery - Ultra-High-Molecular-Weight Polyethylene -Part 2: Moulded Forms.

The subject device also includes the utilization of the GMK Sphere E-cross tibial insert FLEX, already cleared (K202022) in case of retention of an efficient posterior cruciate ligament in the Kinematic Alignment configuration.

The Kinematic Alignment surgical technique was already cleared in K173890.

In this case there are no new implants or instruments, GMK Sphere E-cross tibial insert FLEX, already cleared (K202022).

The provided text describes mechanical performance tests for knee implants, not a study evaluating an AI/ML powered device. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria, study details, ground truth, or human-in-the-loop performance for an AI/ML device.

The document is a 510(k) summary for a submission by Medacta International SA for a knee prosthesis, the "GMK-SPHERE Spherika Femurs and Tibial Trays plus". It focuses on demonstrating substantial equivalence to already cleared predicate devices through design comparisons and non-clinical mechanical testing, which is typical for traditional (non-AI/ML) medical devices.

No information about an AI/ML device, its acceptance criteria, or a study proving those criteria are met is present in this regulatory document.

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