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AOS Calcaneal Plating System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K182466

by Advanced Orthopaedic Solutions

Identifiers

510(k) Number
K182466 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 Calcaneal Plating System is a bone fixation device classified as a Plate, Fixation, Bone under the HRS product code. It is designed for internal fixation of calcaneal fractures, providing stable anatomical alignment and secure stabilization to promote proper bone healing. Constructed for orthopedic use, the system includes plates and screws tailored to the anatomical contours of the heel bone, ensuring optimal load distribution and fracture reduction. Its design supports surgical approaches requiring precise fixation while minimizing soft tissue disruption.

This system is supplied sterile and intended for single-use in orthopedic surgical settings. It is intended for use in procedures where calcaneal fracture fixation is required, adhering to standard aseptic techniques. The device is regulated under FDA 510(k) clearance (K182466) as substantially equivalent to predicate devices, classified as Class II with special controls. Storage and handling must comply with sterile medical device protocols to maintain integrity prior to use.

Frequently asked questions

What is the AOS Calcaneal Plating System used for?

The AOS Calcaneal Plating System is designed specifically for internal fixation of calcaneal (heel bone) fractures. Its anatomical contours and secure fixation plates help restore proper alignment, distribute load evenly, and promote optimal bone healing while reducing soft tissue disruption during surgery.

Is the system intended for single-use or reusable applications?

The AOS Calcaneal Plating System is supplied sterile and intended exclusively for single-use in orthopedic surgical settings. This ensures patient safety and compliance with sterile medical device protocols, preventing cross-contamination or compromise of sterility.

How is the system regulated and approved?

The system holds FDA 510(k) clearance (K182466) under the Traditional review pathway, classified as substantially equivalent to predicate devices. It is categorized under the HRS product code (Plate, Fixation, Bone) and adheres to Class II special controls for orthopedic fixation devices.

What storage and handling precautions must be followed?

The system must be stored and handled according to sterile medical device protocols to preserve its integrity before use. This includes maintaining sealed packaging, protecting from contamination, and adhering to manufacturer guidelines for shelf life and environmental conditions.

Does the system support different surgical approaches for calcaneal fractures?

Yes, the AOS Calcaneal Plating System is engineered to accommodate surgical approaches requiring precise fixation. Its design prioritizes stability and anatomical fit, allowing surgeons to achieve secure fracture reduction while minimizing disruption to surrounding soft tissues.

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, K182466 FDA 510 (k) - AOS Calcaneal Plating System, Aos Calcaneal Plating System 510 (k) FDA Premarket Notification K182466 ..., AOS Calcaneal Plating System (K182466) — FDA 510(k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Advanced Orthopaedic Solutions

Sources (1)

  • FDA 510(k) K182466 24 fields · synced Oct 1, 2026