(180 days)
The HLS Uni Evolution and U-KneeTec unicompartmental knee prostheses are indicated for the replacement of the medial or lateral compartment of the femorotibial knee joint when only one compartment is affected, in order to reduce pain and restore knee function in comparison with preoperative status. These devices are indicated in the treatment of primary or secondary femorotibial osteoarthritis. The HLS Uni Evolution and U-KneeTec knee prostheses are intended for cemented use only.
The HLS Uni Evolution prosthesis consists of a metallic distal femoral resurfacing component and a tibial component. Two kinds of tibial component may be associated to the femoral component: one all polyethylene tibial component and one polyethylene metal-backed tibial component. The present device modification submission consists in the addition of a new femoral component, named U-KneeTec, to the current cleared range. This new component is the distal resection version of the HLS Uni Evolution. The U-KneeTec has been designed to be used in association with the already cleared polyethylene tibial component of HLS Uni Evolution. The U-KneeTec is intended for cemented use only.
The provided text is a summary of safety and effectiveness information for a Special 510(k) Premarket Notification for the HLS Uni Evolution and U-KneeTec Unicompartmental Knee Prosthesis. It is a regulatory document affirming substantial equivalence to predicate devices, and therefore does not include information about acceptance criteria, device performance studies, sample sizes, or ground truth establishment that would typically be found in a study report for a new device's performance.
The document states:
"Non-clinical testing was not necessary to determine substantial equivalence between the U-KneeTec and the cited predicate devices."
"It has been determined that the proposed new U-KneeTec described in this submission does not induce any new or higher risk compared to the predicate devices."
This means that the device was approved based on its substantial equivalence to existing legally marketed predicate devices, rather than on new performance studies demonstrating its specific acceptance criteria. The "performance" in this context refers to its similarity to already approved devices.
Therefore, the requested information cannot be extracted from this document. If this were a new device requiring a full performance study, the document would contain sections detailing those aspects.
§ 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.