NuVasive CoRoent Titanium System

510(k) Number

K120918 ↗

FDA Product Code

MAX

Device Class

Class II

Regulation

21 CFR Part 888.3080

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Pulse

  Class I

  CE/MDR GUDID on market

• NuVasive CoRoent System

  Class II

  FDA 510(k) K043405 Active Cleared 7 Feb 2005

• Modification to Nuvasive Neurovision Jjb System

  Class II

  FDA 510(k) K062765 Active Cleared 24 Jan 2007

• Nuvasive Spherx Ii - Pedicle Screw System

  Class II

  FDA 510(k) K092287 Active Cleared 6 Oct 2009

• Nuvasive Spherx Ii -Mas Deformity Spinal System

  Class II

  FDA 510(k) K102514 Active Cleared 1 Dec 2010

• Nuvasive NVM5 System

  Class II

  FDA 510(k) K123307 Active Cleared 23 Apr 2013

See all devices from Nuvasive, Inc. →

• What types of spinal conditions is the NuVasive CoRoent Titanium System designed to address in the thoracolumbar region?

  The NuVasive CoRoent Titanium System is specifically designed to replace unstable or diseased vertebral bodies in the thoracolumbar spine, spanning from T1 to L5. It is intended to restore structural integrity and provide spinal stabilization through intervertebral body fusion, addressing degenerative or pathological conditions that compromise vertebral stability in this region.

• Is the NuVasive CoRoent Titanium System reusable, or is it meant for single-use only?

  The NuVasive CoRoent Titanium System is explicitly intended for single-use only in surgical procedures. It is supplied sterile and packaged for one-time use, eliminating the need for additional sterilization before implantation. This design ensures patient safety and reduces the risk of cross-contamination.

• What materials is the device made from, and how does this affect its compatibility with MRI scans?

  The NuVasive CoRoent Titanium System is constructed from titanium alloy (Ti-6Al-4V), meeting ASTM F136 and ISO 5832-3 standards. Due to its metallic composition, the device is MRI-unsafe, meaning it cannot be used in patients who require MRI imaging post-surgery without risking image distortion or potential injury.

• How many sizes does the NuVasive CoRoent Titanium System come in, and why is this important for surgical planning?

  The system is available in multiple sizes to accommodate varying anatomical and pathological conditions in the thoracolumbar spine. This modularity allows surgeons to select the appropriate implant dimensions for precise fit and optimal stabilization, improving outcomes by reducing the risk of improper sizing or graft migration.

• What regulatory pathway was followed for FDA clearance of the NuVasive CoRoent Titanium System, and what does this mean for its clinical use?

  The NuVasive CoRoent Titanium System received FDA 510(k) clearance (K120918) under the Traditional Review pathway, with a determination of Substantially Equivalent (SESE) to a predicate device. This means the FDA evaluated it against an existing orthopedic implant standard and confirmed it meets safety and effectiveness requirements for its intended use in spinal fusion procedures, ensuring compliance with U.S. regulatory standards.