Ascension Ankle Fusion Nail System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K100925 FDA 510(k)
- FDA Product Code
- HSB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3020 FDA 510(k)
- Regulation Number
- 888.3020 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Ascension Ankle Fusion Nail System is an intramedullary fixation device designed for ankle arthrodesis (fusion) or fracture fixation. It consists of titanium 6AL-4V nails in specified lengths, fixation screws, and end caps, providing mechanical stabilization to surgically prepared bones. This device is classified under orthopedic instrumentation and is intended for internal fixation within clinical settings. Its primary function is to facilitate bone fusion or fracture healing through rigid stabilization.
The system is implanted via insertion into long bones by surgeons in controlled clinical environments. It is supplied as a sterile, single-use device, with titanium components ensuring biocompatibility and structural integrity. The device is regulated under FDA 510(k) clearance (K100925) and adheres to orthopedic fixation standards. No MRI safety information is specified, and proper storage follows manufacturer guidelines to maintain sterility and functionality.
Frequently asked questions
What is the Ascension Ankle Fusion Nail System used for?
The Ascension Ankle Fusion Nail System is designed specifically for ankle arthrodesis (fusion) or fracture fixation. It provides mechanical stabilization to surgically prepared bones, facilitating bone fusion or fracture healing through rigid internal fixation. This is achieved by inserting titanium nails into the long bones of the ankle, supplemented by fixation screws and end caps.
How is the Ascension Ankle Fusion Nail System supplied and prepared for use?
The system is supplied as a sterile, single-use device, ensuring it meets clinical sterility standards out of the box. It is intended for use in controlled surgical environments, where surgeons implant the titanium components directly into the patient’s bones. The sterile packaging maintains both sterility and functionality until immediate preoperative use.
Are the components of the Ascension Ankle Fusion Nail System reusable?
No, the Ascension Ankle Fusion Nail System is explicitly designed for single-use only. This is a standard practice for orthopedic fixation devices to prevent cross-contamination and ensure patient safety. Reuse could compromise sterility and structural integrity, risking complications during surgery.
What materials are used in the Ascension Ankle Fusion Nail System, and why?
The system is constructed from titanium 6AL-4V, a biocompatible alloy known for its strength, corrosion resistance, and compatibility with human tissue. Titanium’s properties ensure the nails and screws maintain structural integrity during fixation while minimizing adverse reactions in the body.
How should the Ascension Ankle Fusion Nail System be stored to preserve its integrity?
The device must be stored according to the manufacturer’s guidelines to maintain sterility and functionality. This typically involves keeping it in its original, unopened packaging in a clean, dry environment, protected from moisture, extreme temperatures, and physical damage. Proper storage prevents degradation of the titanium components and ensures the system remains ready for surgical use.
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: ASCENSION ANKLE FUSION NAIL SYSTEM (K100925) — FDA 510 (k) | Innolitics, PDF KIOO9~ S - Food and Drug Administration, PDF K100925 - Ascension Ankle Fusion Nail System
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K100925 | Class II | Active |
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Manufacturer
- Manufacturer
- Ascension Orthopedics, Inc.
Sources (1)
- FDA 510(k) K100925 24 fields · synced Oct 1, 2026