ulrich medical USA has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its Flux-C 3D printed porous titanium cervical interbody device.
The device has been developed using a 3D printing process, which is known as direct metal laser sintering (DMLS).
The company stated that the Flux-C 3D porous titanium devices have a side window and large graft window that will allow for obtaining improved radiographic imaging.
It also noted that the devices are available in several parallel and lordotic options with different heights.
ulrich Medical USA Technology director Eric Lucas said: “We are continuing to develop procedural solutions for reconstruction of all spinal pathologies in collaboration with our Surgeon Advisory Board.
“We strive to help our surgeons and distributors achieve new heights and beyond with integrity, through excellence in design, manufacturing, and craftsmanship.”
The company’s Surgeon Advisory Board member Patrick Maloney stated that the Flux-C porous titanium device provides superior endplate contact, as well as spaces for inter-device bone grafting.
Founded in Germany in 1912, the medical device firm develops a complete portfolio of spine solutions.
It offers surgical instruments, imaging diagnostics, hospital devices, and spinal implant systems in more than 80 countries.
In 2019, ulrich medical USA launched the Solidity Vertebral Body Replacement (VBR) device to the country’s spine implant market.
The Solidity implant includes a main centre piece, with 625 end cap configurations available in a single set.
It is designed to allow a maximum range of device access in order to support any surgical method.
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