EVOLUTION Tibial Cones
510(k) K233507
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK233507 | Date18 Jan 2024 | 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- Withdrawn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
- MBH
- FDA applicant
- Microport Orthopedics, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3565
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Evolution Tibial Cones are orthopedic implants classified under the Orthopedic Device category, specifically designed for use in revision total knee arthroplasty procedures. These cones are intended to address metaphyseal bone loss by providing stable fixation in the tibial component, ensuring secure attachment during surgery.
Supplied as part of the Evolution Revision Tibia System, these cones are intended for cemented tibial fixation and are used in revision knee surgeries to restore function and stability. The device is single-use, requires sterile handling, and is regulated under FDA 510(k) clearance (K233507) with a Traditional review pathway. No MRI safety information is specified, and sizes are determined by the system’s compatibility with the Evolution Revision Tibia System.
Other devices from MicroPort Orthopedics Inc.
Questions
AI-generated answers, 18 Sep 2026
What types of knee surgeries are the Evolution Tibial Cones specifically designed for, and why are they used in those procedures?
The Evolution Tibial Cones are designed for revision total knee arthroplasty procedures, where significant metaphyseal bone loss has occurred. They provide stable fixation in the tibial component by filling gaps created by bone loss, ensuring secure attachment during surgery. This helps restore function and stability in knees that have undergone previous knee replacements or have deteriorated over time.
Are the Evolution Tibial Cones reusable, or are they intended for single-use only? How does this affect their handling and storage?
The Evolution Tibial Cones are single-use only, meaning they must be handled under sterile conditions to prevent contamination. This design ensures patient safety by eliminating the risk of cross-infection or device degradation from reuse. Proper storage in a clean, dry environment away from direct sunlight is recommended to maintain sterility until use.
How are the sizes of the Evolution Tibial Cones determined, and do they come with a specific system for compatibility?
The sizes of the Evolution Tibial Cones are determined by their compatibility with the Evolution Revision Tibia System, meaning they are not standalone devices. The system’s design ensures proper fit and fixation in revision knee surgeries, so selection must align with the specific tibial component being used in the procedure.
What regulatory pathway was followed for FDA clearance of the Evolution Tibial Cones, and what does this mean for clinicians?
The Evolution Tibial Cones received FDA 510(k) clearance (K233507) through the Traditional review pathway, which means the manufacturer demonstrated that the device is substantially equivalent to a legally marketed predicate device. Clinicians can rely on this clearance as evidence of safety and effectiveness for use in revision total knee arthroplasty, though they should always follow manufacturer instructions and institutional protocols.