(30 days)
The Performance Knee System is indicated for use:
- Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
- Correction of varus, valgus, or posttraumatic deformity.
- Correction or revision of unsuccessful osteotomy, arthrodesis, or failure or previous joint replacement procedure.
The device is intended for use with bone cement.
The femoral augmentation blocks (FAB) may be used individually or in combinations; in a variety of positions to create an implant that fits the patient's needs. The modular femoral augmentation blocks are fastened to the femoral knee component with a locking screw. Femoral augmentation blocks are manufactured from titanium (Ti-6Al-4V) alloy with the geometry to match a corresponding size femoral component.
The provided text is a 510(k) submission for a medical device (Performance Knee System - Femoral Augmentation Blocks) and does not contain information about a study proving the device meets specific acceptance criteria using performance metrics. This document is focused on demonstrating substantial equivalence to a predicate device rather than presenting a detailed performance study with acceptance criteria.
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, study details, expert involvement, or ground truth for this specific device from the provided text.
The document primarily states:
- Device: Performance Knee System - Femoral Augmentation Blocks
- Intended Use: For painful and disabled knee joints due to various arthritic conditions, correction of deformities, and revision of previous knee procedures, for use with bone cement.
- Substantial Equivalence: Direct comparison was made with the "Performance Knee System" (which appears to be the same device or a closely related component system).
- Regulatory Outcome: The FDA reviewed the 510(k) and determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.
This type of submission focuses on demonstrating that the new device is as safe and effective as a legally marketed predecessor, often based on similar design, materials, and intended use, rather than presenting novel clinical study performance data against specific numerical acceptance criteria.
§ 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.