EVOLUTION Revision Tibial Base, EVOLUTION Revision Tibial Block Augment, EVOLUTION Revision Modular Keels, EVOLUTION Revision Stem Adapters (offset and extension), EVOLUTION Revision Cemented Stem Extensions, Canal Filling Stem Extensions
510(k) K162026
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK162026 | Date1 Mar 2017 | 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- Withdrawn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 Revision Tibial System is a modular orthopedic implant designed for knee revision surgery. It includes a cemented tibial base, modular keels, block augments, stem adapters (offset and extension), and stem extensions (cemented and canal-filling) to address fixation challenges in patients with compromised bone stock while preserving joint kinematics.
Implanted by orthopedic surgeons in a clinical or hospital setting, this system is intended for use in revision knee procedures. The components are supplied sterile and intended for single-use, with modularity allowing intraoperative customization to match individual patient anatomy. The device carries FDA 510(k) clearance under the traditional review pathway, classified under product code JWH.
From the manufacturer
Manufacturer's product page: Revision Total Knee Systems
Other devices from MicroPort Orthopedics Inc.
Questions
AI-generated answers, 18 Sep 2026
What types of knee revision procedures is this tibial system designed to support, and how does its modularity help during surgery?
The Evolution Revision Tibial System is specifically designed for knee revision surgeries where patients have compromised bone stock, requiring careful fixation solutions. Its modular components—including the tibial base, block augments, modular keels, stem adapters (offset and extension), and stem extensions (cemented or canal-filling)—allow surgeons to customize the implant *intraoperatively* to match the patient’s unique anatomy. This adaptability helps address fixation challenges, preserve joint alignment, and restore stability without relying on a one-size-fits-all approach.
Is this system intended for reuse, or is each component meant to be used only once?
The Evolution Revision Tibial System is explicitly supplied sterile and intended for single-use only. This aligns with standard orthopedic implant practices to ensure patient safety and sterility, as reuse could compromise integrity and introduce infection risks. Each component is designed for one-time implantation during revision knee procedures.
What are the key differences between the cemented stem extensions and the canal-filling stem extensions in this system?
The cemented stem extensions are secured to the tibial base using bone cement, providing a fixed connection that relies on the adhesive properties of the cement for stability. In contrast, the canal-filling stem extensions are designed to be inserted directly into the medullary canal of the tibia, filling voids or weak bone areas to enhance primary fixation without requiring additional cement. The choice between them depends on the patient’s bone quality and the surgeon’s preference for fixation strategy.
How is this device regulated in the U.S., and what does the FDA’s clearance under product code JWH indicate?
This system holds FDA 510(k) clearance under the traditional review pathway, classified under product code JWH (Orthopedic Knee Prosthesis). The clearance indicates that the device is deemed *substantially equivalent* to a legally marketed predicate, meaning it meets the same performance standards and safety requirements for use in knee revision surgeries. The classification reflects its role as an orthopedic implant rather than a diagnostic or non-surgical device.