(90 days)
The DePuy Graduated Compartmental Knee (GCK) is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.
The GCK is indicated for single or multi-compartmental knee replacement in skeletally mature individuals with osteoarthritis, posttraumatic arthritis of the tibiofemoral and/or patellofemoral articular surfaces or a history of gout or pseudogout. All GCK components are intended for CEMENTED USE ONLY.
The DePuy GCK is composed of unicompartmental femoral components, patellofemoral trochlear components, unicompartmental tibial components and patellar components. These components may be used in various combinations to create a single or multicompartmental knee replacement prosthesis.
The GCK Unicompartmental Femoral Components are a modification of the Preservation® Unicondylar Femoral Components. They are manufactured from Co-Cr-Mo and are available in sizes 1-6 in left medial / right lateral and right medial / left lateral versions. The fixation surface is available with or without a beaded porous coating.
The GCK Patellofemoral Trochlear Components are a modification of the PFC Sigma® Femoral Components. They are manufactured from Co-Cr-Mo and are available in sizes 1-5 in left and right versions. The fixation surface is available with or without a beaded porous coating.
The GCK All Polyethylene Unicompartmental Tibial Components are a modification of the Preservation All Polyethylene Unicondylar Tibial Components. They are manufactured from XLK cross-linked polyethylene and are available in sizes 1-6, 5 thicknesses (8-12mm) and in left medial / right lateral and right medial / left lateral versions.
The patella components used with the GCK are the PFC Sigma Inset, Oval and Round Dome Patellae. These patellar components have been previously cleared for use in total knee arthroplasty.
I am sorry, but this document does not contain the information you are looking for. This is a 510(k) premarket notification for a medical device (DePuy Graduated Compartmental Knee), which establishes substantial equivalence to predicate devices. It does not describe an AI/ML device or a study evaluating its performance with acceptance criteria.
The document discusses:
- The device description (components, materials, modifications from existing products).
- Indications for use (for knee replacement in individuals with osteoarthritis, post-traumatic arthritis, or gout/pseudogout).
- Substantial equivalence to other legally marketed predicate devices.
- The FDA's decision to allow the device to be marketed.
Therefore, I cannot provide the requested information about acceptance criteria, device performance, ground truth, study design, or expert involvement as these details pertain to the evaluation of an AI/ML medical device, which is not the subject of this 510(k) summary.
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.