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510(k) Data Aggregation
(135 days)
EVOLUTION MP ADAPTIVE PS TIBIAL INSERT
The EVOLUTION® MP Adaptive PS Insert is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:
- Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
- Inflammatory degenerative joint disease including rheumatoid arthritis;
- Correction of functional deformity;
- Revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.
The EVOLUTION® Total Knee System is for cemented use only.
The purpose of this submission is to introduce a new EVOLUTION® MP Adaptive PS Tibial Insert that allows use of a posterior stabilized femoral component from the EVOLUTION® MP Total Knee System with a tibial base from the ADVANCE® Knee System.
The design features of the EVOLUTION® Adaptive CS Insert are summarized below:
- Tibial inserts manufactured from UHMWPE
- Available in 7 sizes, left and right
- Tibial insert thickness: 10 20mm
This document does not describe an AI/ML medical device. It pertains to a physical medical device, specifically a tibial insert for knee arthroplasty. Therefore, the requested information regarding acceptance criteria, study details, ground truth, and expert involvement for an AI/ML device is not applicable and cannot be extracted from this text.
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