(184 days)
Knee femoral components are single use devices implanted in the human knee during total knee arthroplasty. This knee is intended for cement use only.
The proposed fluted, stemmed tibials are made of forged Tivanium® Ti-6Al-4V Alloy. Like the tibials, NexGen® Complete Knee Solution, the fluted stemmed tibials cover a multitude of patient specific needs by mating with the NexGen Knee CR, CRA, PS, L-PS and L-CCK articular surfaces. The proposed fluted stemmed tibial component shares many features with the NexGen Knee stemmed tibials discussed above. It is the same in these respects: - Length of the stem - Angle of the stem relative to the distal plate surface - Position of the cylindrical portion of the stem in the anterior/posterior direction - Stem extension locking taper design - Articular surface locking mechanism - Minimum taper wall thickness - Depth of the cement mantle pockets in the distal plate surface, size offerings, and material. The primary difference between the proposed fluted stemmed tibial components and the cleared stemmed tibial component involves the stem base shape. The proposed design uses flutes like the Insall/Burstein® Knee predicate design. The stem base shape has a posterior slope similar to the Insall/Burstein Knee. The stem base has a flute on both the lateral and medial edges which provide channels to direct cement flow from the distal tip to the proximal surface of the cut tibial during insertion, thus, enhancing cement fixation. These flutes give the implant its name. The cleared stemmed tibial component ribs have been replaced by integral flared supports at the base of the stem.
This document describes a medical device, the NexGen® Complete Knee Solution Fluted Stemmed Tibial Component, and its submission for regulatory clearance (K963148). The provided text focuses on the device's description, its similarities and differences to predicate devices, and its intended use.
Crucially, the document does not contain information on acceptance criteria or a study proving the device meets specific performance metrics in the context of an "AI" or "diagnostic" device.
The "Performance Data" section simply states: "The performance data was submitted in the 510(k) for fatigue strength." This refers to a standard mechanical engineering test for the implant's durability, not a study involving AI, human readers, or diagnostic accuracy.
Therefore, I cannot answer your specific questions in the requested format, as the provided text lacks the necessary information for a diagnostic or AI-related performance evaluation. The information you're asking for typically relates to the validation of a software algorithm or a diagnostic tool, which is not the subject of this particular document.
§ 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.