← Back to catalogue

Biospine VBR System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K110864

by Aesculap Implant Systems, Llc

Identifiers

510(k) Number
K110864 FDA 510(k)
FDA Product Code
MQP FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3060 FDA 510(k)
Regulation Number
888.3060 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Biospine VBR System is a vertebral body replacement device classified as a spinal fixation implant. It is designed for partial or total replacement of a collapsed, damaged, or unstable vertebral body in the thoracolumbar spine (T1 to L5) due to trauma or tumor-related instability. Constructed to restore structural integrity, the system is intended for use in conjunction with supplemental spinal fixation systems to ensure stability and alignment during spinal reconstruction.

The device is supplied sterile and intended for single-use. It is regulated under FDA 510(k) clearance (K110864) as substantially equivalent to a predicate device, with approval for use in orthopedic spinal procedures. Storage and handling must comply with sterile medical device protocols, and its design adheres to MRI safety standards for spinal implants. Sizes and configurations are tailored for specific vertebral body replacements, as detailed in the accompanying surgical specifications.

Frequently asked questions

What is the Biospine VBR System used for?

The Biospine VBR System is designed for partial or total replacement of a collapsed, damaged, or unstable vertebral body in the thoracolumbar spine (T1 to L5). It addresses instability caused by trauma or tumor-related conditions and is intended to restore structural integrity during spinal reconstruction. The device is specifically paired with supplemental spinal fixation systems to ensure stability and proper alignment.

Is the Biospine VBR System sterile and single-use?

Yes, the Biospine VBR System is supplied sterile and intended for single-use only. This ensures patient safety and reduces the risk of infection or cross-contamination, aligning with standard sterile medical device protocols for surgical implants.

What sizes and configurations are available for the Biospine VBR System?

The Biospine VBR System comes in tailored sizes and configurations specifically designed for different vertebral body replacements in the thoracolumbar spine. Exact dimensions and options are detailed in the accompanying surgical specifications provided by AESCULAP IMPLANT SYSTEMS, LLC. These specifications help surgeons select the appropriate size for optimal fit and stability.

How should the Biospine VBR System be stored?

The Biospine VBR System must be stored and handled according to sterile medical device protocols to maintain its integrity and sterility. Proper storage conditions, such as temperature and humidity control, are critical to preserving the device’s performance and safety for surgical use.

Does the Biospine VBR System comply with MRI safety standards?

Yes, the design of the Biospine VBR System adheres to MRI safety standards for spinal implants. This ensures compatibility with MRI imaging procedures, allowing for postoperative monitoring without compromising patient safety or device performance.

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: BIOSPINE VBR SYSTEM (K110864) — FDA 510 (k) | Innolitics, PDF Aesculap Biospine VBR System COMPANY: Aesculapolmplant Systems, Inc ..., Aesculap Implant Systems, LLC

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Aesculap Implant Systems, Llc

Sources (1)

  • FDA 510(k) K110864 24 fields · synced Oct 1, 2026