Modulus TLIF Interbody System
510(k) K172341
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK172341 | Date26 Oct 2017 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- NuVasive® Modulus TLIF Interbody System
- 510(k) Number
- FDA Product Code
- MAX
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3080
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Modulus TLIF Interbody System is a spinal interbody fusion device classified as an interbody spinal fusion device (FDA Product Code: MAX). It is designed for use in transforaminal lumbar interbody fusion (TLIF) procedures, providing structural support and promoting bony fusion between vertebrae in the lumbar spine. Constructed from titanium alloy, the system offers mechanical stability and corrosion resistance, with a porous design to enhance osseointegration. Its radiolucent properties facilitate intraoperative imaging and postoperative assessment.
The system is supplied as a sterile, single-use device intended for surgical use in spinal fusion procedures. It is regulated under the FDA’s 510(k) pathway, with clearance granted as substantially equivalent to a predicate device. Implants are available in various sizes to accommodate different anatomical requirements, and the porous titanium structure is optimized for strength while maintaining radiolucency. Storage and handling follow standard sterile surgical instrument protocols, ensuring compatibility with MRI environments where applicable. No additional regulatory approvals beyond the FDA 510(k) clearance (K172341) are stated in the specifications.
Other devices from Nu Vasive, Incorporated
Questions
AI-generated answers, 1 Oct 2026
What is the NuVasive Modulus TLIF Interbody System used for?
The NuVasive Modulus TLIF Interbody System is designed specifically for transforaminal lumbar interbody fusion (TLIF) procedures. It is used to provide structural support between vertebrae in the lumbar spine, promoting bony fusion while maintaining stability. The system’s porous titanium alloy construction encourages osseointegration, ensuring long-term integration with the surrounding bone.
How is the Modulus TLIF Interbody System supplied and prepared for use?
The system is supplied as a sterile, single-use device, meaning each implant is intended for one surgical procedure only. This ensures patient safety by preventing cross-contamination. Before use, follow standard sterile surgical instrument protocols to maintain sterility and compatibility with intraoperative imaging.
What materials are used in the Modulus TLIF Interbody System, and why?
The system is constructed from titanium alloy, chosen for its mechanical stability and corrosion resistance. The porous design of the titanium enhances osseointegration, allowing the implant to bond effectively with the patient’s bone. Additionally, its radiolucent properties enable clear intraoperative imaging and postoperative assessment.
Are there different sizes available for the Modulus TLIF Interbody System?
Yes, the Modulus TLIF Interbody System is available in various sizes to accommodate different anatomical requirements. This modularity ensures that surgeons can select the appropriate implant dimensions for optimal fit and fusion outcomes in each patient’s specific lumbar spine anatomy.
Can the Modulus TLIF Interbody System be used in MRI environments?
The system is designed with radiolucent properties, which means it is compatible with MRI environments where applicable. However, always verify compatibility with your specific MRI machine settings and follow manufacturer guidelines to ensure safe imaging without interference or artifacts.