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Mega Spine System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K072436

by Bk Meditech Co., Ltd.

Identifiers

510(k) Number
K072436 FDA 510(k)
FDA Product Code
MNI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3070 FDA 510(k)
Regulation Number
888.3070 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Mega Spine System is a spinal implant device designed for orthopedic applications, specifically for spinal stabilization and fusion procedures. It consists of modular components intended to support and reconstruct the spine, providing structural integrity to the vertebral column. This system falls under the classification of spinal fixation devices, offering solutions for complex spinal pathologies requiring internal bracing.

The system is supplied non-sterile and intended for single-use, fabricated from titanium alloy (Ti-6Al-4V ELI) compliant with ASTM F136 standards. It is cleared by the FDA under 510(k) authorization (K072436) and falls under the Product Code MNI for spinal fixation devices. Components are intended for surgical use in controlled environments, such as operating rooms, and must be sterilized prior to implantation as per standard surgical protocols.

Frequently asked questions

What is the Mega Spine System used for?

The Mega Spine System is designed for spinal stabilization and fusion procedures in orthopedic surgery. It provides structural support to the spine by reconstructing and reinforcing the vertebral column, particularly for complex spinal pathologies where internal bracing is required. The modular components allow for customization to address specific anatomical needs.

How is the Mega Spine System supplied and prepared for use?

The Mega Spine System is supplied in a non-sterile state and is intended for single-use only. Prior to implantation, it must be sterilized following standard surgical protocols, as it is not sterile at the time of delivery. Sterilization should be performed in a controlled environment, such as a hospital sterilization department, to ensure safety and efficacy before surgical use.

What material is the Mega Spine System made from, and why is this important?

The Mega Spine System is fabricated from titanium alloy (Ti-6Al-4V ELI), which complies with ASTM F136 standards. Titanium alloy is chosen for its excellent biocompatibility, high strength-to-weight ratio, and corrosion resistance, making it ideal for spinal implants that require durability and integration with bone tissue over time.

Is the Mega Spine System reusable, or is it designed for single-use?

The Mega Spine System is explicitly designed for single-use only. This design choice aligns with best practices in orthopedic surgery to minimize infection risks and ensure patient safety. Reuse of medical devices, particularly implants, is discouraged unless explicitly approved for such use, which is not the case here.

What regulatory approval does the Mega Spine System hold, and how does this affect its use?

The Mega Spine System holds FDA 510(k) clearance under the reference number K072436, indicating it has been deemed substantially equivalent to a legally marketed predicate device. This approval allows for its use in spinal fixation procedures within the United States, provided it is used according to the manufacturer’s instructions and standard surgical protocols. The clearance does not imply universal applicability but confirms compliance with FDA standards for spinal 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: MEGA SPINE SYSTEM (K072436) — FDA 510 (k) | Innolitics, BK Meditech, PDF BK Meditech, Co., Ltd ℅ Nathan Wright Engineer & Regulatory Specialist ..., Bk Meditech Co.,Ltd. 97405-50 Mega Plus Mis Spine System

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Bk Meditech Co., Ltd.
FDA Applicant
Bk Meditech, Co., Ltd.

Sources (1)

  • FDA 510(k) K072436 24 fields · synced Oct 1, 2026