Maxx Orthopedics Inc
The purpose of this investigational device exemption (IDE) study is to monitor the performance (safety and efficacy) of the Maxx Orthopedics, Freedom Total Knee® System, with a femoral component of similar design, manufactured from polyether-ether-ketone (PEEK).
The purpose of this investigational device exemption (IDE) study is to monitor the performance (safety and efficacy) of the Maxx Orthopedics, Freedom Total Knee® System, with a femoral component of similar design, manufactured from polyether-ether-ketone (PEEK). PEEK is a high-performance, engineering thermoplastic characterized by an unusual combination of properties. These properties range from high temperature performance to mechanical strength and excellent chemical resistance. The PEEK-OPTIMA® femoral component, is an investigational device and is the subject of this study approved for…
Inclusion Criteria: * Male and female subjects 18 years of age or older. * Subjects with a primary diagnosis of end-stage symptomatic unilateral primary knee osteoarthritis. * Subjects with a pre-operative Knee Society Score (KSS) Knee score of \>25 and \<75. * Subjects who, in the opinion of the Investigator, can understand this clinical investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups. * Subjects who can give voluntary, written informed consent to participate in this clinical investigation…
Primary Total Knee Arthroplasty with a PEEK femoral component
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