Market Overview

FBC Device ApS Receives First FDA Clearance For Spinal Interbody Implant Providing Lordosis Adjustment from 9 to 21 Degrees to Aid Surgeons & Patients


FBC Device ApS, a medical device company focused on restoring natural
alignment of the spine through innovative interbody implants, has
received its first US FDA clearance for its technology, enabling access
to the US market.

Professor Finn Christensen, MD, PhD and founder and CEO of FBC Device
says: "There is overwhelming evidence that poor spinal alignment is
associated with back pain and disability. When we started the company,
our goal was to commercialize a series of implants to help surgeons
easily restore alignment when performing spinal fusions, so that more of
their patients would achieve good or even great results. We have now
accomplished three elements crucial to reaching our goal:

  • Regulatory approval, now in the US along with a second implant that
    has been CE marked since 2013.
  • Patents granted around the world to protect these two implant designs
    as well as others to follow.
  • Documented clinical evidence demonstrating that the technology enables
    surgeons to restore normal alignment and that patients receiving the
    technology have excellent results in patient-based outcome measures."

The FDA clearance brings FBC Device one step closer to its goal. To
fully commercialize its products, the Company will immediately engage
interested parties capable of bringing the technology to large markets
across the world.

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About the FBC Technology

Each individual has different alignment requirements – it is not one
size fits all. The FBC technology is a two-piece interbody fusion device
that allows for in-situ adjustment from 9-21 degrees, enabling surgeons
to simply adjust alignment for each patient's need and then lock the two
pieces relative to each other.

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