Modulus XLIF Interbody System

No FDA recalls found in the data synced 22 Oct 2026.

Full name

NuVasive® Modulus XLIF Interbody System

510(k) Number

K172123 ↗

FDA Product Code

MAX

Device Class

Class II

Regulation

21 CFR Part 888.3080

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• NuVasive 3DP Interfixated ALIF System

  Class II

  FDA 510(k) K193593 Active Cleared 25 Mar 2020

• Nuvasive NVM5 System

  Class II

  FDA 510(k) K132694 Active Cleared 16 May 2014

• CoRoent® Ti-C System

  Class II

  FDA 510(k) K160916 Active Cleared 28 Jun 2016

• NuVasive VersaTie System

  Class II

  FDA 510(k) K161265 Active Cleared 15 Jul 2016

• Mlx - Medial Lateral Expandable Lumbar Interbody System

  Class II

  FDA 510(k) K140770 Active Cleared 25 Jul 2014

• NuVasive® TLX Interbody System

  Class II

  FDA 510(k) K153627 Active Cleared 17 Mar 2016

See all devices from Nu Vasive, Incorporated →

• What types of bone graft materials can be used with the NuVasive® Modulus XLIF Interbody System, and why is this important?

  The NuVasive® Modulus XLIF Interbody System is designed to be used with autogenous (patient’s own bone) or allogeneic (donor bone) grafts, including cancellous and corticocancellous types. This flexibility is important because the device’s 3D-printed titanium implant with a porous endplate and optimized lattice structure is engineered to promote bone ingrowth and fusion stability, ensuring better integration with the graft material for successful spinal fusion.

• Is the NuVasive® Modulus XLIF Interbody System intended for reuse, and if not, why is single-use recommended?

  No, the NuVasive® Modulus XLIF Interbody System is explicitly labeled as a single-use device. This is because spinal implants must maintain sterility and structural integrity throughout the surgical procedure, and reuse could compromise these critical factors, potentially leading to infection or mechanical failure. The system is packaged to ensure sterility is preserved until first use.

• How should the NuVasive® Modulus XLIF Interbody System be stored to maintain its integrity, and why does this matter?

  The device must be stored in its original packaging to preserve sterility and prevent contamination. This is critical because spinal implants are implanted directly into the body, and any compromise to sterility could introduce harmful bacteria or particles, increasing the risk of infection or adverse reactions. Improper storage could also damage the 3D-printed titanium structure, affecting its performance in promoting bone fusion.

• Can the NuVasive® Modulus XLIF Interbody System be used with patients who have not yet reached skeletal maturity, and why?

  No, the device is specifically designed for skeletally mature patients only. This restriction is likely due to the biological and mechanical differences in immature spinal structures, where fusion outcomes and implant stability may not be as predictable as in fully developed skeletons. Using it in younger patients could risk complications related to growth or improper integration.

• Why is the NuVasive® Modulus XLIF Interbody System not MRI-safe, and what does this mean for postoperative care?

  The system is not MRI-safe, meaning it contains materials (such as titanium) that could cause artifacts or heating during MRI scans, potentially distorting imaging results or posing safety risks. This means postoperative patients will need alternative imaging modalities (like CT scans or X-rays) for follow-up evaluations unless specifically cleared by the manufacturer for certain MRI protocols, which is not indicated here.