APEX 3D Total Ankle Replacement System
FDA 510(k)Class II (US FDA 510(k))
by Paragon 28
Identifiers
- 510(k) Number
- K202373 FDA 510(k)
- FDA Product Code
- HSN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3110 FDA 510(k)
- Regulation Number
- 888.3110 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The APEX 3D Total Ankle Replacement System is a semi-constrained, cemented prosthesis designed for total ankle arthroplasty. It is composed of metal and polymer components, intended to replace a damaged ankle joint and restore function in patients with end-stage ankle arthritis. The system is engineered to address common complications such as implant loosening, wear, and instability, providing a durable solution for long-term ankle mobility.
This system is supplied as a sterile, single-use device and is intended for use in orthopedic surgical settings. It is classified as a Class II medical device under FDA regulations and has received 510(k) clearance. The system includes multiple component sizes and configurations, as referenced by the listed FEI numbers, to accommodate varying patient anatomies. Proper storage and handling per manufacturer instructions are required to maintain sterility and functionality.
Frequently asked questions
What is the APEX 3D Total Ankle Replacement System used for?
The APEX 3D Total Ankle Replacement System is designed to replace a damaged ankle joint in patients suffering from end-stage ankle arthritis. It is engineered to restore function and mobility by addressing common complications such as implant loosening, wear, and instability, providing a durable solution for long-term ankle mobility.
How is the APEX 3D Total Ankle Replacement System supplied and what does sterility mean in this context?
The system is supplied as a sterile, single-use device, meaning each package is intended for one surgical procedure only. Sterility ensures that the components are free from harmful microorganisms, reducing the risk of infection during surgery. Proper handling and storage per manufacturer instructions are critical to maintain this sterility and functionality.
What component sizes and configurations are available for the APEX 3D Total Ankle Replacement System?
The system includes a variety of component sizes and configurations, each identified by unique FEI numbers (e.g., 3010375065, 3009923578). These sizes accommodate different patient anatomies, allowing for a tailored fit to optimize implant stability and function. The full list of FEI numbers is provided in the specifications.
Is the APEX 3D Total Ankle Replacement System reusable or single-use?
The APEX 3D Total Ankle Replacement System is explicitly designed for single-use only. This ensures sterility and safety for each surgical procedure, as reuse could compromise the integrity of the components and increase infection risks. Always follow manufacturer guidelines for proper disposal after use.
How should the APEX 3D Total Ankle Replacement System be stored to maintain its integrity?
The system must be stored according to the manufacturer’s instructions to preserve sterility and functionality. This typically includes keeping the device in its original packaging, in a clean, dry environment, and away from direct sunlight or extreme temperatures. Improper storage could damage components or compromise sterility, affecting performance during surgery.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: APEX 3D™ Total Ankle Replacement System - Paragon 28, Total Ankle Replacement - Paragon 28, Patients — APEX 3D™ Total Ankle Replacement System, APEX 3D™ Total Ankle Replacement System - Paragon 28
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K202373 | Class II | Active |
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Manufacturer
- Manufacturer
- Paragon 28
- FDA Applicant
- Paragon 28, Inc.
Sources (1)
- FDA 510(k) K202373 24 fields · synced Oct 1, 2026