Identifiers
- 510(k) Number
- K141911 FDA 510(k)
- FDA Product Code
- GWO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.5320 FDA 510(k)
- Regulation Number
- 882.5320 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Optimus Neuro System is a preformed, alterable cranioplasty plate designed for reconstructive neurosurgery. It is intended to restore cranial contour and integrity following craniectomy procedures, providing structural support and protection to the underlying brain tissue.
This device is supplied as a sterile kit and is classified as Class II under FDA regulations (21 CFR 882.5320). It is intended for single-use and must be handled in a sterile surgical environment. The system is MRI-safe and available in multiple sizes to accommodate various patient anatomies. Authorized under FDA 510(k) clearance (K141911), it adheres to neurology-specific standards for cranioplasty applications.
Frequently asked questions
What types of patients is the Optimus Neuro System designed to accommodate, and how does sizing work?
The Optimus Neuro System is designed for reconstructive neurosurgery following craniectomy procedures and comes in multiple sizes to match various patient anatomies. The system is preformed but alterable, allowing surgeons to customize the fit during surgery. The exact range of sizes isn’t specified, but the device’s availability in multiple configurations ensures compatibility with a broad range of cranial contours. Always verify the specific sizes included in your kit or consult the manufacturer’s sizing guide for precise matching.
Is the Optimus Neuro System reusable, or is it intended for single-use only? How should it be handled?
The Optimus Neuro System is explicitly intended for single-use only and must be handled in a sterile surgical environment. This ensures patient safety and compliance with FDA guidelines for Class II devices. The sterile kit packaging is designed for one-time use, and reuse is not recommended or supported by the manufacturer.
Can this device be used safely in an MRI environment, and what considerations should clinicians keep in mind?
Yes, the Optimus Neuro System is MRI-safe, meaning it can be used in MRI environments without interfering with imaging or posing risks to the patient. However, clinicians should confirm compatibility with their specific MRI machine settings and follow standard MRI safety protocols, such as verifying the device’s positioning and ensuring no metallic debris is present. Always consult the manufacturer’s instructions for MRI-specific guidance.
How is the device supplied, and what should be checked upon receipt to ensure proper use?
The Optimus Neuro System is supplied as a sterile kit, which includes all necessary components for immediate surgical use. Upon receipt, verify the sterility indicators (e.g., peel pouches or sterile barriers) are intact and uncompromised. Check the expiration date, size specifications, and any included instructions or labeling for accuracy. The kit should be stored in a clean, dry environment away from direct sunlight until use.
What regulatory pathway was followed for FDA clearance, and what does this mean for clinicians?
The Optimus Neuro System received FDA 510(k) clearance (K141911) through a *Traditional* review pathway, determined to be *Substantially Equivalent* to a legally marketed predicate device. This means the FDA evaluated it against existing cranioplasty standards (e.g., structural integrity, biocompatibility) and confirmed it meets safety and effectiveness requirements for neurology-specific applications. Clinicians can rely on this clearance as evidence of the device’s regulatory compliance for cranioplasty procedures.
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: OPTIMUS NEURO SYSTEM (K141911) — FDA 510(k) | Innolitics, Osteonic Co., Ltd. South Korea Manufacturers, suppliers, K190811 - Optimus NEURO System - Sterile Kit - Neurology, Optimus Neuro System (K183352) — FDA 510 (k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K141911 | Class II | Active |
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Manufacturer
- Manufacturer
- OSTEONIC CO., Ltd.
Sources (1)
- FDA 510(k) K141911 24 fields · synced Sep 19, 2026