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Monkey Rings External Ring Fixation System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K253613

by Paragon 28

Identifiers

510(k) Number
K253613 FDA 510(k)
FDA Product Code
KTT 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 Monkey Rings External Ring Fixation System is a circular external fixation device designed for orthopedic applications, specifically for stabilizing complex fractures, deformity correction, and limb salvage procedures. It employs external wires and screws anchored into bone to maintain anatomical alignment while minimizing soft tissue disruption. This system is categorized under external fixation devices, providing modular stability for long-bone and joint reconstruction.

This device is supplied as a reusable orthopedic fixation system, intended for use in clinical settings such as trauma centers and orthopedic surgery departments. It is not sterile at time of shipment and must be sterilized prior to use, adhering to standard medical device sterilization protocols. The system is classified under FDA 510(k) clearance (K253613) as a Special Class II device, with a product code of KTT. Compliance with regulatory standards ensures its suitability for orthopedic surgical applications requiring external stabilization.

Frequently asked questions

What types of orthopedic procedures is the Monkey Rings External Ring Fixation System primarily used for?

The Monkey Rings External Ring Fixation System is designed for stabilizing complex fractures, correcting deformities, and performing limb salvage procedures. It uses external wires and screws anchored into bone to maintain alignment while reducing soft tissue disruption, making it suitable for long-bone and joint reconstruction in trauma or orthopedic surgery settings.

Is the Monkey Rings External Ring Fixation System intended for single-use or can it be reused?

The system is explicitly described as a reusable orthopedic fixation device, meaning it is meant for repeated use in clinical settings after proper sterilization between procedures. It is not supplied sterile at shipment and must undergo sterilization prior to each use.

How should the Monkey Rings External Ring Fixation System be stored before use?

Since the system is reusable and non-sterile at shipment, it must be stored in a clean, dry environment following manufacturer guidelines until sterilization. Proper storage ensures the device remains functional and ready for sterilization when needed for surgical procedures.

What regulatory pathway was followed for the Monkey Rings External Ring Fixation System’s approval?

The device was cleared through the FDA’s 510(k) process as a Special Class II device under product code KTT, with a clearance number of K253613. The submission was reviewed by the Orthopedic (OR) Advisory Committee and determined to be substantially equivalent to a predicate device.

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: Monkey Rings™ External Fixation System - Paragon 28, External Fixation Systems - Paragon 28, Paragon 28 Launches Monkey Rings Circular External Fixation, Monkey Rings™ External Fixation System — FDA Class II Medical Device ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Paragon 28
FDA Applicant
Paragon 28, Inc.

Sources (1)

  • FDA 510(k) K253613 24 fields · synced Sep 20, 2026