Infinity Total Ankle System
by Wrightmedicaltechnologyinc 510(k)
Active
510(k) K181557
Overview
The Infinity Total Ankle System is a Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer, as classified by the FDA. It is a fixed-bearing, two-piece total ankle prosthesis designed to replace the natural ankle joint, restoring flexion and extension movement while reducing pain and improving alignment in patients with end-stage ankle arthritis.
The system is supplied as a sterile, single-use implant and consists of a titanium alloy tibial tray, cobalt chromium talar dome, and polyethylene insert. It is intended for use in orthopedic surgical settings and requires cement fixation. The device is authorized under FDA 510(k) clearance (K181557) and falls under regulation number 888.3110, classified as a Class II medical device. Multiple FEI numbers (e.g., 3010375065) correspond to its various configurations.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK181557 | Date9 Aug 2018 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- HSN
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3110
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Other devices from Wrightmedicaltechnologyinc
Questions
What types of materials are used in the Infinity Total Ankle System, and why is this important for patients?
The Infinity Total Ankle System is constructed from titanium alloy for the tibial tray, cobalt chromium for the talar dome, and polyethylene for the insert. These materials are chosen for their durability, biocompatibility, and ability to withstand the mechanical stresses of ankle movement while reducing wear and corrosion over time. Titanium and cobalt chromium are particularly favored in orthopedic implants for their strength-to-weight ratios and resistance to fatigue, ensuring long-term stability and reducing the risk of complications like loosening or infection.
Is the Infinity Total Ankle System intended for reuse, or is it designed for single-use only? How does this affect surgical planning?
The Infinity Total Ankle System is explicitly designed as a sterile, single-use implant. This means each component is intended for one surgical procedure only and should not be reused or reprocessed. Clinicians must plan accordingly, ensuring proper sterilization of surrounding instruments and supplies while accounting for the system’s one-time use to avoid contamination risks or procedural delays.
What sizes or configurations are available for the Infinity Total Ankle System, and how do I determine the correct fit for a patient?
The Infinity Total Ankle System comes in multiple configurations, as indicated by its extensive list of FEI numbers (e.g., 3010375065, 3009923578). These variations likely correspond to different sizes, alignment angles, or component combinations (e.g., tibial tray sizes, talar dome profiles) to accommodate diverse patient anatomies. Selection should be based on preoperative imaging (e.g., CT or MRI scans) and consultation with the manufacturer’s sizing tools or surgical guides to ensure proper alignment, stability, and range of motion post-implantation.
How should the Infinity Total Ankle System be stored before use, and are there any specific handling instructions to maintain sterility?
As a sterile, single-use implant, the Infinity Total Ankle System must be stored in its original, unopened packaging in a clean, dry environment protected from moisture, extreme temperatures, and direct sunlight. The packaging should remain intact until immediately before use to preserve sterility. Follow the manufacturer’s instructions for handling, including avoiding contamination of the components (e.g., no direct contact with gloved hands unless sterile barriers are used) and adhering to expiration dates if applicable.
What is the regulatory pathway for the Infinity Total Ankle System, and how does this affect its availability or use in clinical settings?
The Infinity Total Ankle System is authorized under FDA 510(k) clearance (K181557) and classified as a Class II medical device under regulation number 888.3110. This clearance indicates the device has been deemed substantially equivalent to a legally marketed predicate device, meeting FDA requirements for safety and effectiveness. Clinicians can rely on this approval to confirm the system’s compliance with U.S. regulatory standards, though local hospital policies or state laws may further dictate its use, such as procurement or inventory protocols.