(96 days)
The Freedom® Total Knee System is indicated for patients with severe knee pain and the disability due to:
· Severe knee joint pain, loss of mobility, and disability due to: rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
· Correction of functional deformities.
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· Post-traumatic loss of knee joint contour, particularly when there is patellofemoral erosion,
dysfunction, or prior patellectomy. -
· Moderate valgus, varus, or flexion trauma.
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· Knee fractures untreatable by other methods.
· Revision surgery where sufficient bone stock and soft tissue integrity are present.
The Freedom® Total Knee System is intended for cemented and for single use only.
The Freedom® Total Knee System is comprised of a femoral component, all-poly tibial component, patellar component, tibial base plate and tibial articular surface. The Freedom® Total Knee System's Femoral Component is offered as different versions such as stemmed PCK design, primary PCK, cruciate retaining, posterior stabilizing. The Freedom® Total Knee System's Tibial Base Plate is offered with stemmed design and without stemmed design.
This submission seeks the clearance of Titanium Nitride (TiNbN) coated version of previously cleared Stemmed PCK Femoral Component (non-coated version cleared in K131481) and Stemmed Tibial Base Plate (non-coated version cleated in K111785). The coated versions are now branded as Titan PCK Stemmed Femoral Component and Titan Stemmed Tibial Base Plate.
Both these components are manufactured from CoCrMo alloy and are coated completely with Titanium Niobium Nitride (TiNbN).
This document is a 510(k) premarket notification for a medical device, the Freedom® Total Knee System, and does not contain information about the development or testing of an AI/ML powered medical device. Therefore, I cannot extract the requested information regarding acceptance criteria or a study proving an AI/ML device meets those criteria.
The document discusses the substantial equivalence of a new version of a total knee system (with a TiNbN coating) to previously cleared versions. The "performance testing" section refers to mechanical and biocompatibility tests for the physical knee implant components and their coating, not the performance of a software or algorithm. There is no mention of AI, machine learning, or any related technology.
§ 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.