(147 days)
The Freedom® Total Knee Cruciate Retaining (CR) Femoral Component consists of a cobalt-chromium molybdenum (CoCrMo) femoral component designed to be used with the Freedom® Total Knee System, and the Freedom® Total Knee Metal Backed Tibial Components. The Freedom Total Knee System is indicated for the following:
- Severe knee joint pain, loss of mobility, and disability due to: rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
- Correction of functional deformities,
- Post-traumatic loss of knee joint contour, particularly when there is patellofemoral erosion, dysfunction, and/or prior patellectomy.
- Moderate valgus, varus, or flexion trauma.
- Knee fractures untreatable by other methods
The Freedom® Total Knee Cruciate Retaining (CR) Femoral Component is intended for cemented use only. This device is for single use only.
The Maxx Orthopedics' Freedom® CR Femoral Component is compatible with the Maxx Orthopedics Freedom® Total Knee System subject of K082019 and the Metal Backed Tibial Component subject of K090411. The Maxx Orthopedics' Freedom® Total Knee System subject of K082019 is comprised of a femoral component, tibial component and patella component.
The proposed Freedom® CR Femoral Component consist of a cobalt-chromium molybdenum (CoCrMo) component that is designed to be used with the Freedom® Total Knee System described in K082019 and the Freedom Metal Backed Tibial Component subject of K090411. The Maxx Orthopedics' Freedom® Total Knee System subject of K082019 is comprised of a femoral component (posterior stabilizing), an all-poly tibial component, and a patellar component. The Freedom Metal Backed Tibial Component subject of K090411 consists of a metal backed tibial component and polyethylene insert. The proposed CR Femoral Component will provide the surgeon with an alternative femoral component in the event that the surgeon prefers to use a CR component rather than the PS component with the Freedom® Total Knee System. In addition, a second metal backed tibial component was cleared for use with the Freedom Total Knee System under K090411. The proposed CR Femoral Component and a (UHMWPE) insert will be used in place of the PS Femoral component with the Freedom® Total Knee System.
The CR Femoral Component of the Freedom® Total Knee System CR is designed to replace the articulating surface of the distal femur. The cruciate retaining femoral component is utilized when total knee replacement is indicated, and accommodates the posterior cruciate ligament if it is present.
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets those criteria. The document is a 510(k) summary for a medical device (Freedom® Total Knee Cruciate Retaining (CR) Femoral Component) and focuses on describing the device, its intended use, and its substantial equivalence to predicate devices, along with some general information about performance testing.
Specifically, the document states:
- "Mechanical and functional testing described in K082019, K090411 and in Section 8 demonstrates that the Freedom® CR Femoral Component are mechanically and functionally similar to the parent Freedom UHMWPE Tibial Component and other legally marketed knee systems."
- "Evaluations were performed to determine the material and mechanical characteristics of the Maxx Orthopedics' Freedom® CR Femoral Component and the Freedom® Total Knee System according to the Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Fernorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA."
- "The verification and validation testing have been performed which demonstrate that the CR Femoral Component functions as intended and is safe and effective for its intended use."
However, it does not provide:
- A table of specific acceptance criteria.
- Reported device performance against those criteria.
- Details about sample size, data provenance, expert involvement, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment for software/AI components. This is likely because the device is a physical knee implant, not a software or AI-driven diagnostic/treatment tool.
Therefore, I cannot provide the requested table and information.
§ 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.