(81 days)
The Klassic® Revision System is intended for prosthetic replacement in treatment of the following:
- · Patient conditions of non-inflammatory degenerative joint disease (NIDID): avascular necrosis and osteoarthritis
- Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis
- · Patients with failed previous surgery where pain, deformity, or dysfunction persists
- · Correctable varus-valgus deformity and moderate flexion contracture
- · Revision of a previously failed knee arthroplasty
- · Patients who require a total knee replacement
The Klassic® Revision System is indicated for cemented use only, except for the Klassic® Femur, with Cobalt 3D®, the Klassic® Tibial Baseplate with Ti-Coat® and the Universal Cones™ with Ti-Coat®, which are also indicated for cementless use.
The Klassic® Revision System is being introduced as a line extension for use with the Klassic® Knee System during total knee arthroplasty. The Klassic® Revision System includes the following implants and implant materials: Klassic® Stem Extension, Femoral, Cemented (Ti6Al4V), Klassic® Stem Adapter, Femoral (Ti6A14V), Klassic® Posterior Femoral Augment (Ti6A14V), Klassic® Distal Femoral Augment (Ti6Al4V), Klassic® Tibial Augment (Ti6Al4V, UHMWPE), Posterior Femoral Augment Set Screw (Ti6A14V), Distal Femoral Augment Set Screw (Ti6Al4V), Universal Cone™ with Ti-Coat (Ti6A14V and unalloyed Ti powder).
The provided text is an FDA 510(k) clearance letter for the Klassic® Revision System, a knee replacement system. It details the device's indications for use, description, predicate devices, and a summary of non-clinical testing.
However, this document does not contain information on an AI/ML-driven medical device, nor does it provide details about acceptance criteria, study methodologies (like sample sizes, expert involvement, ground truth establishment, MRMC studies, or training set details) related to the performance of such a device.
The "Discussion of Non-Clinical Testing/Performance Data" section solely refers to mechanical and material testing (fatigue, torque disassembly, fretting corrosion, augment fixation, porous coating characterization) relevant to the physical components of the knee replacement system. This type of device does not involve AI/ML components that would require a study proving its diagnostic or predictive performance, nor does it refer to human readers or human-in-the-loop performance.
Therefore, I cannot provide the requested information based on the given text.
§ 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.