Skip to content

Velofix Interbody Fusion System

by U&I Corporation 510(k)

Active United States

510(k) K190067

Overview

The Velofix Interbody Fusion System is a spinal interbody fusion device classified as an Interbody Fusion Device (FDA Product Code: ODP). It consists of polyetheretherketone (PEEK) cervical and lumbar cages designed to restore disc height, maintain spinal alignment, and facilitate intervertebral fusion through structural support and bone graft integration.

The system is implanted via anterior (cervical) or posterior (lumbar, including PLIF/TLIF) approaches and features an open architecture for autogenous bone graft packing. Sterility and single-use status are implied by regulatory submission (FDA 510(k) K190067), though explicit details require manufacturer documentation. No MRI safety classification is stated in the provided data.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK190067 Date4 Feb 2019ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
ODP
Device Class
Class II
Regulation
21 CFR Part 888.3080
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Other devices from U&I Corp.

See all devices from U&I Corp. →

Questions

  • What surgical approaches can the Velofix Interbody Fusion System be used with, and how does this affect its placement?

    The Velofix Interbody Fusion System is designed for use via either an anterior approach for cervical spine procedures or a posterior approach for lumbar spine procedures, including PLIF (Posterior Lumbar Interbody Fusion) and TLIF (Transforaminal Lumbar Interbody Fusion). This flexibility allows surgeons to choose the most clinically appropriate route based on patient anatomy and surgical preference, ensuring optimal access and placement for spinal stabilization.

  • Is the Velofix Interbody Fusion System intended for reuse, or is it meant to be used only once? How does this impact clinical workflow?

    The Velofix Interbody Fusion System is single-use only, as implied by the FDA 510(k) submission (K190067). This design ensures sterility and reduces the risk of cross-contamination, which is critical in spinal surgery where infection control is paramount. Clinicians should follow manufacturer guidelines for handling and disposal to maintain compliance and workflow efficiency.

  • What material is the Velofix Interbody Fusion System made of, and how does this influence its performance in spinal fusion procedures?

    The Velofix Interbody Fusion System is constructed from polyetheretherketone (PEEK), a biocompatible polymer known for its strength, radiolucency, and ability to integrate with bone. This material choice helps restore disc height, maintain spinal alignment, and facilitate fusion by providing structural support while allowing bone graft integration through its open architecture design.

  • Are there different sizes or models of the Velofix Interbody Fusion System, and if so, how do they accommodate varying patient anatomies?

    While the provided data does not specify exact sizes or model variations, the Velofix Interbody Fusion System is designed as a cervical and lumbar interbody fusion device, implying tailored options for different spinal segments. Manufacturers typically offer a range of cage sizes to accommodate varying patient anatomies, ensuring proper fit and alignment during surgery. For precise sizing details, clinicians should refer to the manufacturer’s technical documentation.

  • How should the Velofix Interbody Fusion System be stored to ensure its integrity before use?

    Since the system is single-use and sterile (as implied by the FDA submission), storage must follow manufacturer-recommended protocols to preserve sterility and structural integrity. This typically includes keeping the device in its original packaging, away from moisture, extreme temperatures, and direct sunlight, until immediately before use. Proper storage ensures the device remains ready for surgical implantation without degradation.