Identifiers
- 510(k) Number
- K132005 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 Retrograde Femoral Nail is a device used for intramedullary fixation of fractures of the femur. It is designed for the treatment of open and closed femoral fractures, pseudoarthrosis, and related conditions as specified in its intended use.
The device is supplied by Advanced Orthopaedic Solutions, Inc. and has received FDA 510(k) clearance under K132005. It is classified under product code HSB and was determined to be substantially equivalent to a predicate device. The nail is intended for use in orthopedic surgical settings and is provided as a non-sterile, reusable instrument unless otherwise specified in the manufacturer's labeling.
Frequently asked questions
What is the Retrograde Femoral Nail used for?
The Retrograde Femoral Nail is used for intramedullary fixation of fractures of the femur, including open and closed femoral fractures, pseudoarthrosis, and related conditions as specified in its intended use.
Is the Retrograde Femoral Nail sterile or non-sterile when supplied?
The Retrograde Femoral Nail is supplied as a non-sterile instrument, meaning it must be sterilized by the user before surgical use unless otherwise specified in the manufacturer's labeling.
Can the Retrograde Femoral Nail be reused after sterilization?
Yes, the Retrograde Femoral Nail is intended as a reusable instrument, provided it is properly cleaned and sterilized between uses according to the manufacturer's instructions and standard hospital reprocessing protocols.
What regulatory pathway was used for the Retrograde Femoral Nail?
The Retrograde Femoral Nail received FDA 510(k) clearance under submission number K132005, demonstrating substantial equivalence to a predicate device under the traditional review pathway.
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: AOS—Advanced Orthopaedic Solutions Homepage, Retrograde nailing for Simple, transverse, distal 1/3 fractures, Retrograde nailing approach to the femoral shaft, AOS ES Retrograde Femoral Nail by Advanced Orthopaedic Solutions, Inc ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K132005 | Class II | Active |
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Manufacturer
- Manufacturer
- Advanced Orthopaedic Solutions, Inc.
Sources (1)
- FDA 510(k) K132005 24 fields · synced Sep 26, 2026