AOS Small Fragment Plating System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K152732 FDA 510(k)
- FDA Product Code
- HRS FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3030 FDA 510(k)
- Regulation Number
- 888.3030 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The AOS Small Fragment Plating System is a surgical orthopedic device classified as a Fracture Fixation Device (per orthopedic nomenclature). It is designed for internal fixation of small bone fractures and non-unions, providing stable fixation to promote proper bone healing. The system includes plates, screws, and associated instrumentation tailored for use in osteopenic bone environments, where traditional fixation may be compromised by reduced bone density.
This system is supplied as a sterile, single-use device intended for use in orthopedic surgical settings. It is intended for clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula applications. The device is regulated under FDA 510(k) clearance (K152732) and adheres to traditional review standards. No MRI safety information is specified, and storage conditions are not detailed in the provided data.
Frequently asked questions
What types of bone fractures is the AOS Small Fragment Plating System specifically designed to address, and why is it suitable for those areas?
The AOS Small Fragment Plating System is designed for internal fixation of small bone fractures and non-unions in osteopenic (low bone density) environments. It is tailored for use in clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula. Its suitability for these areas comes from its specialized plates and screws, which provide stable fixation even where traditional fixation methods may fail due to compromised bone density.
Is the AOS Small Fragment Plating System intended for reuse, and what are the implications of its single-use nature?
No, the AOS Small Fragment Plating System is explicitly supplied as a sterile, single-use device. This design ensures patient safety by preventing cross-contamination and maintaining sterility, which is critical in orthopedic surgery where infection risks can significantly impact outcomes. Single-use also simplifies inventory management and reduces the need for reprocessing.
How should the AOS Small Fragment Plating System be stored, and are there any specific handling instructions mentioned?
The provided data does not specify storage conditions for the AOS Small Fragment Plating System. However, as a sterile, single-use orthopedic device, it should generally be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Always follow manufacturer guidelines (e.g., those in the included packaging or user manual) for optimal preservation of sterility and functionality.
What regulatory pathway was followed for FDA clearance of the AOS Small Fragment Plating System, and how does this affect its use?
The AOS Small Fragment Plating System received FDA 510(k) clearance (K152732) under the Traditional Review pathway, classified as a Fracture Fixation Device in the orthopedic category. This means it was determined to be substantially equivalent to a legally marketed predicate device, ensuring compliance with U.S. regulatory standards for safety and effectiveness. Clinicians and buyers can rely on this clearance as confirmation of its adherence to FDA requirements for orthopedic fixation devices.
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, AOS Small Fragment Plating System (K161913) — FDA 510(k) | Innolitics, Aos Small Fragment Plating System 510 (k) FDA Premarket Notification ..., K181035 - AOS Small Fragment Plating System Lite | FDA 510(k)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K152732 | Class II | Active |
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Manufacturer
- Manufacturer
- Avanced Orthopaedic Solutions, Inc. (Aos)
Sources (1)
- FDA 510(k) K152732 24 fields · synced Sep 19, 2026