Products

FDA Cleared Bone Graft Substitutes

Vitrium received FDA 510(k) clearance in 2014 and CE mark in 2020 for use as a bone graft substitute for a range of implant shapes for use in non-load bearing applications. It has been used in foot, ankle and trauma applications since FDA clearance with excellent results.

Vitrium Cervical lnterbody Device (IBD) for Fusion

Novum Medical developed the Vitrium Cervical IBD implant to aid in the fusion of the cervical disc space. Over time, the implant is replaced by the patient’s own bone. When the fusion process is completed, there is no material left behind as with traditional fusion devices where either a metal or plastic implant remains permanently in the body.

Bone slowly and steadily replaces Vitrium during your bodies natural healing process, offering the opportunity to not have a foreign material in your disc space forever. Unlike most materials, Vitrium encourages natural bone growth onto and through the porous material of the entire device allowing for the full area between the disc spaces to become fused. Without obstruction by foreign material, Vitrium provides a larger fusion area that can add strength to the overall fusion site.

Caution: Investigational Device. Limited by Federal (or United States) Law to investigational use.

Comparison of Available Vertebral Endplate Area for
Potential Fusion using a Vitrium Interbody Device Versus a Similarly Sized Titanium or PEEK Plastic Device.

Vitrium Cervical lnterbody Device for Fusion in the disc space

Representation of Vitrium Cervical lnterbody Fusion Device after transitioning into bone showing the potential full endplate fusion coverage. Only the patients bone remains in the disc space and the Vitrium material is completely gone and resorbed by the body in a natural process.

Comparable representation of a Titanium or PEEK Plastic interbody fusion device shown in the disc space

A Titanium or PEEK Plastic interbody device for fusion shows the Fusion will primarily occur in the central hole. The Titanium or Plastic implant will remain permanently in the body. The space taken by the metal or plastic implant will not fuse.

Both fusion bed examples assume the common practice of surgeon packing bone on the sides and in front of the device.

Novum Medical is developing several unique Lumbar Spine lnterbody Fusion Devices specific to patient need and surgical approach.

Lumbar Interbody Device products currently under development include:

ALIF (Anterior Lumbar Interbody Fusion) device, is designed specifically for use in an anterior lumbar surgical approach through the front of the abdomen.
LLIF (Lateral Lumbar Interbody Fusion) device, is designed specifically for use in a lateral lumbar approach through the side of the patient.