EVOLUTION Cement Keel
510(k) K231947
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK231947 | Date31 Oct 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- Withdrawn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
- 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 Cement Keel is a cemented orthopedic implant designed for use in total knee arthroplasty procedures. It serves as a structural component to enhance fixation and stability of the tibial baseplate within the bone, ensuring long-term integration with bone cement.
This device is supplied as a single-use implant and is intended for use in sterile surgical environments. It is classified under product code JWH and has received FDA 510(k) clearance through the Traditional pathway. The keel is part of the Evolution Cemented Knee System and is regulated as a Class 2 Orthopedic device.
From the manufacturer
The Evolution ® medial-pivot knee system addresses the limitations of traditional designs and today's patient needs by delivering superior flexion stability, anatomic motion, and wear-limiting design characteristics through three primary knee options. 1-7 The three options offered are: Cruciate-Substituting (CS), Cruciate-Retaining (CR), and Posterior Stabilized (PS).
The Evolution® Medial-Pivot Knee System delivers 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 is the primary purpose of the Evolution Cement Keel in knee replacement surgery?
The Evolution Cement Keel is designed to improve the fixation and stability of the tibial baseplate during total knee arthroplasty. It works by embedding into bone cement, creating a stronger structural bond that helps ensure long-term integration between the implant and the bone.
Is the Evolution Cement Keel intended for reuse in multiple surgeries, or is it meant for single-use?
The Evolution Cement Keel is explicitly supplied as a single-use implant, meaning it is intended for use in one surgical procedure only. This aligns with standard orthopedic implant practices to maintain sterility and patient safety in sterile surgical environments.
How is the Evolution Cement Keel regulated, and what pathway was used for FDA clearance?
The Evolution Cement Keel is classified as a Class 2 Orthopedic device under product code JWH and received FDA 510(k) clearance through the Traditional pathway. This means its safety and effectiveness were compared to a legally marketed predicate device to demonstrate substantial equivalence.
What type of surgical setting is required for the use of the Evolution Cement Keel?
The Evolution Cement Keel is intended for use in sterile surgical environments, as it is a single-use implant. This ensures proper aseptic techniques are followed during total knee arthroplasty to prevent infection and maintain implant integrity.