EVOLUTION Stemmed CS Femur
510(k) K182125
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK182125 | Date6 Dec 2018 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- JWH
- FDA applicant
- Microport Orthopedics, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3560
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Evolution Stemmed CS Femur is a stemmed femoral component for total knee arthroplasty, designed for revision procedures. It features a modular design with distal and posterior augments to restore anatomical alignment and stability in complex cases, while maintaining the kinematic benefits of a medial-pivot articulation.
This device is supplied as a sterile, single-use implant and is intended for use in MRI-safe environments (as per manufacturer specifications). Available in multiple sizes to accommodate varying femoral anatomy, it is secured via cemented or canal-fitting stems for enhanced fixation. Authorized under FDA 510(k) clearance (K182125), it adheres to traditional orthopedic submission pathways.
From the manufacturer
Built on a 25 year, clinically-established heritage of patient satisfaction and survivorship. It is the only revision knee system that eliminates box resection while maintaining the proven kinematic benefits of a medial-pivot design and offering surgeons intraoperative flexibility to meet all patient needs.
With all of the benefits of the Evolution® medial-pivot knee system in articulation, the Evolution® adaptive stemmed femur also offers distal and posterior augments plus added stability with cemented and canal fitting stems.
Microport | Evolution® Stemmed CS System. Built on a 20 year, clinically-established heritage of patient satisfaction and survivorship. It is the only revision knee system that eliminates box resection while maintaining the proven kinematic benefits of a medial-pivot design and offering surgeons intraoperative flexibility to meet all patient needs.
Other devices from MicroPort Orthopedics Inc.
Questions
AI-generated answers, 18 Sep 2026
What types of knee revision surgeries is the Evolution Stemmed CS Femur specifically designed for, and how does its modular design help in these cases?
The Evolution Stemmed CS Femur is designed for complex total knee arthroplasty revision procedures where anatomical alignment and stability are challenging. Its modular design includes distal and posterior augments, which allow surgeons to customize the implant to restore proper bone geometry and fixation. This adaptability helps address bone loss or deformities often encountered in revisions, ensuring better stability and kinematic performance through a medial-pivot articulation.
Is this device suitable for patients who require MRI scans after implantation, and why?
Yes, the Evolution Stemmed CS Femur is designed for use in MRI-safe environments, as specified by the manufacturer. This means it can be implanted in patients who may need MRI imaging post-surgery, provided the scan parameters align with the device’s MRI-safe specifications. Always confirm with the manufacturer’s guidelines or MRI facility protocols to ensure compatibility.
How is the Evolution Stemmed CS Femur secured in place during surgery, and what fixation options are available?
The device is secured via either a cemented stem or a canal-fitting stem, depending on the clinical scenario and surgeon preference. Cemented fixation provides immediate stability through bone cement, while canal-fitting stems rely on press-fit engagement with the femoral canal for long-term fixation. The choice depends on bone quality, patient anatomy, and surgical goals.
Are there multiple sizes available for this femoral component, and how does this accommodate different patients?
Yes, the Evolution Stemmed CS Femur is available in multiple sizes to accommodate varying femoral anatomies. This sizing flexibility ensures that surgeons can select the appropriate implant to match the patient’s bone dimensions, improving fit, stability, and functional outcomes during revision knee arthroplasty.
How should the Evolution Stemmed CS Femur be stored, and is it intended for single-use only?
The device is supplied as a sterile, single-use implant, meaning it should not be reused after a single surgical procedure. Storage instructions typically require it to remain in its original, unopened packaging until use, protected from contamination and extreme temperatures. Always follow the manufacturer’s storage guidelines to maintain sterility and integrity.