EVOLUTION Hinge Knee System
510(k) K230563
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK230563 | Date27 Sep 2023 | 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- Withdrawn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
- KRO
- FDA applicant
- Microport Orthopedics, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3510
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
This device is a Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer, designed to replace damaged knee joints. It provides constrained motion to stabilize the knee while allowing controlled flexion and extension, suitable for patients requiring enhanced stability due to severe joint degradation or instability.
The Evolution Hinge Knee System is intended for cemented use in total knee arthroplasty procedures. It is supplied sterile and intended for single-use, though specific sterilization methods are not detailed in the data. The device is classified under FDA Device Class II and adheres to regulatory requirements outlined in 21 CFR 888.3510. No MRI safety information or reusable components are specified.
From the manufacturer
The Evolution® Medial-Pivot knee system is designed to answer the limitations of traditional implants by delivering superior flexion stability, anatomic motion, and wear-limiting design characteristics.
Manufacturer's product page: Evolution® Kinematic Alignment
Other devices from MicroPort Orthopedics Inc.
Questions
AI-generated answers, 18 Sep 2026
What types of knee instability or joint damage is the Evolution® Hinge Knee System specifically designed to address in patients?
The Evolution® Hinge Knee System is designed for patients with severe joint degradation or instability who require enhanced knee stability. Its constrained design provides controlled flexion and extension, making it suitable for cases where traditional knee prostheses may not offer sufficient support, such as in advanced osteoarthritis or severe ligamentous deficiency.
Is the Evolution® Hinge Knee System intended for use with cement, and if so, how does this affect its application in surgery?
Yes, the Evolution® Hinge Knee System is explicitly designed for cemented use in total knee arthroplasty procedures. This means the prosthesis is secured to the bone using bone cement, ensuring stable fixation during and after surgery. The cemented design is particularly useful for patients with compromised bone quality or those requiring immediate weight-bearing stability.
How is the Evolution® Hinge Knee System supplied, and what should clinicians expect regarding sterility and single-use guidelines?
The Evolution® Hinge Knee System is supplied sterile and is intended for single-use only. While the specific sterilization method isn’t detailed, the sterile packaging ensures readiness for immediate surgical use without additional processing. Clinicians should adhere to single-use protocols to maintain sterility and patient safety.
What regulatory pathway was followed for the FDA clearance of the Evolution® Hinge Knee System, and what does this mean for its clinical use?
The Evolution® Hinge Knee System received FDA clearance through a 510(k) Traditional pathway, classified as Substantially Equivalent (SESE) under the Orthopedic advisory committee (OR). This means the device was determined to be as safe and effective as a legally marketed predicate device, allowing it to be marketed for its intended use in total knee arthroplasty with constrained motion for enhanced stability.
Are there multiple sizes or models available for the Evolution® Hinge Knee System, and how might this impact surgical planning?
The provided data lists multiple FEI numbers (e.g., 3004748528, 3009173317), which correspond to different sizes or configurations of the Evolution® Hinge Knee System. These variations allow surgeons to select the appropriate implant size and design to match the patient’s anatomy and clinical needs, ensuring a tailored fit for optimal function and stability.