Search Results

noninflammatory degenerative joint disease including osteoarthritis or traumatic arthritis, avascular necrosis of the femoral condyle, post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus or flexion deformities, theumatoid arthritis, treatment of fractures that are unmanageable using other techniques. This device is for cemented use only.

The resurfacing and pegged tibial components are available in six sizes, articulate with the existing Foundation® Knee System. The baseplates are fabricated from wrought Ti-6Al-4V that conforms to ASTM F136. The under side of both baseplates is plasma sprayed with commercially pure titanium to provide a roughened surface to enhance cement fixation. The resurfacing baseplate has four smooth pegs and two screw holes to allow the use of 6.5 mm cancellous type screws. The resurfacing component has a notch cut out posteriorly to allow retention of the posterior cruciate ligament. The stemmed tibial baseplate has a stem for rotational stability and four screw holes.

This document, K970031, is a 510(k) premarket notification for a medical device (Tibial Component for knee replacement). It is a regulatory submission focused on demonstrating substantial equivalence to a predicate device for market clearance. It does not contain the information requested in your prompt regarding acceptance criteria, study details, performance metrics, ground truth, or sample sizes related to a device's performance evaluation against acceptance criteria.

The prompt's questions are typically answered by performance studies (clinical or bench) conducted for devices that involve algorithms, image analysis, or other functionalities where performance needs to be quantified against a defined set of criteria. This document describes a physical implant and discusses its design and indications for use, comparing it to existing, already cleared devices.

Therefore, I cannot extract the requested information from the provided text.

Ask a specific question about this device