Medical device manufacturer Nvision Biomedical Technologies and Watershed Idea Foundry have received FDA approval for what is claimed to be the world's first 3D printed titanium anterior cervical spine plate.

The medical device, called the Quantum Titanium Cervical Plate System, is a small plate that is typically used to provide stability to the spine after surgery.

By 3D printing their cervical plate, Nvision and Watershed have been able to take advantage of the design benefits of additive manufacturing to combine multiple smaller components into a monolithic part. According to the companies, this significantly reduces the risk of accidental disassembly of the device by the patient. The 3D printed Quantum Titanium cervical plate system also helps to reduce manufacturing costs and lead times compared to its conventionally manufactured counterpart.

Nvision Biomedical Technologies and Watershed Idea Foundry are sister companies operating under the umbrella of Fountainhead Investment Partners. They have previously collaborated on other 3D printed medical products, such as wedges and interference screws.

"It's very exciting for us to enable new product enhancements through additive manufacturing," said Nick Cordaro, CEO of Watershed Idea Foundry. "Nvision is open to incorporating additive manufacturing innovations into commercial products to enable ideal technology transfer scenarios."

Quantum Titanium Cervical Plate System

What is an anterior cervical plate?

Developed back in the 1980s, anterior cervical plates are applied to the anterior spine during surgery to protect bone grafts and provide integrity to spinal structures as they heal. They were initially used for long cervical fusions but are increasingly being used for anterior cervical decompression, cervical fusion, degenerative disc disease and scoliosis.

Traditionally manufactured cervical plates are often expensive to produce and contain several smaller components, meaning they can disassemble themselves if not fitted or tightened correctly, a problem the Quantum Titanium Cervical Plate System aims to address.

Quantum Titanium Cervical Plate System

The most noteworthy innovation of the device is its monolithic nature, in that the screw-locking cap is a single structure that is 3D printed. As there are no multiple components or joints involved, the plate eliminates the risk of disassembly during use.

It also features two different surface finishes, namely a textured rear surface and a polished front surface. The textured surface facilitates osseointegration (fusion) and also absorbs some of the loads that would otherwise be applied to the screws. In addition, some of the screw holes are printed at a 30º angle, a design choice that allows the plate itself to be shorter while still ensuring a secure fixation to the spine.

Tom Zink, Senior Vice President of Product Development at Nvision, explains: "With the Additive Manufacturing Quantum system, we have taken advantage of design options that were not available with machined boards. The active locking system is printed integrally within the plate and therefore never assembled, meaning the lock cannot be disassembled at the surgical site."