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Helena System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K110177

by Royal Oak Medical Devices

Identifiers

510(k) Number
K110177 FDA 510(k)
FDA Product Code
MAX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3080 FDA 510(k)
Regulation Number
888.3080 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Helena System is an intervertebral body fusion device, classified under 21 CFR 888.3080. It is designed to facilitate spinal fusion by providing structural support and stability to the lumbar spine, promoting bony union between adjacent vertebrae. Constructed as a modular implant system, it includes components such as cages and screws to enhance fixation and alignment during surgical intervention. This device is intended for use in orthopedic spinal procedures where internal fixation and fusion are required.

The Helena System is supplied as a sterile, single-use orthopedic implant intended for surgical application in controlled operating room environments. It is available in various sizes to accommodate different anatomical requirements, ensuring compatibility with patient-specific spinal anatomy. The device is regulated under FDA 510(k) clearance (K110177) as substantially equivalent to predicate devices, adhering to traditional review pathways. Storage and handling must comply with sterile medical device protocols to maintain integrity prior to use.

Frequently asked questions

What is the Helena System used for?

The Helena System is designed for intervertebral body fusion in the lumbar spine, providing structural support and stability to facilitate bony union between adjacent vertebrae. It is intended for orthopedic spinal procedures where internal fixation and fusion are required, helping patients regain stability and function after spinal instability or degenerative conditions.

How is the Helena System supplied and where can it be used?

The Helena System is supplied sterile and as a single-use device, intended exclusively for surgical application in controlled operating room environments. Its modular design ensures compatibility with various anatomical requirements, allowing surgeons to select appropriate components for patient-specific cases.

Is the Helena System reusable or single-use?

The Helena System is explicitly designed for single-use only. This ensures sterility and safety during surgical procedures, as reuse could compromise integrity and introduce infection risks. Always follow sterile medical device protocols for handling and storage.

What sizes or models are available for the Helena System?

The Helena System includes multiple modular components, such as cages and screws, available in various sizes to accommodate different anatomical requirements. These components are tailored to match patient-specific spinal anatomy, ensuring proper fit and fixation during fusion procedures.

How should the Helena System be stored before use?

The Helena System must be stored and handled according to sterile medical device protocols to maintain its integrity before surgical use. Improper storage could compromise sterility or damage the implant components, so always follow manufacturer guidelines for packaging and environmental conditions.

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: K110177 FDA 510(k) - HELENA SYSTEM | Royal Oak Medical Devices, Helena System 510 (k) FDA Premarket Notification K110177 ROYAL OAK ..., 510 (k) Premarket Notification, HELENA SYSTEM (K110177) — FDA 510(k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Royal Oak Medical Devices

Sources (1)

  • FDA 510(k) K110177 24 fields · synced Oct 1, 2026