MedicalOrthopedic Implants

FDA clears 3D printed Quantum Titanium Cervical Plate System

First such product cleared in the US, produced by Watershed Idea Foundry and Nvision Biomedical Technologies

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Nvision Biomedical Technologies and Watershed Idea Foundry have received FDA clearance for the first-ever completely additive manufactured titanium anterior cervical plate, the Quantum Titanium Cervical Plate System. Recently cleared by the FDA, the Quantum system leads the way for game-changing design freedoms which push clinical benefits to new levels and ultimately impact patient care.

“It has been incredibly exciting for us to realize new product enhancements made possible by additive manufacturing,” said Nick Cordaro, CEO of Watershed Idea Foundry. “Combining multiple components into single nested 3D printed assemblies is one example of such advancement, which can provide supply chain cost and timeline advantages while reducing patient risks of component disassembly. Nvision’s willingness to champion additive manufacturing innovation into a commercial product made for an ideal technology transfer scenario.”

Nvision Biomedical Technologies and Watershed have received FDA clearance for the first-ever completely AM titanium anterior cervical plateThe Quantum system offers multiple specialized features, including a nested assembly in which the screw-locking cover is 3D printed as a single unit inside the anterior cervical plate, and dual-plate finishes with a textured posterior surface and smooth, polished anterior surface. Enhanced screw holes accommodate 30 degrees of cephalad/caudal angulation, which allows the surgeon to use a shorter plate. Additionally, the Quantum system incorporates Structural Encoding capabilities to address FDA Unique Device Identification (UDI) requirements. This adds up to a more elegant construct design with anatomically optimized placement and increased procedural options and flexibility, which potentially means less time in surgery to benefit both surgeons and patients.

Nvision’s Senior Vice President of Product Development, Tom Zink added, “By additive manufacturing the Quantum system, we leveraged design options that were not available with machined plates. The active locking system is integrally printed within the plates, and therefore never assembled, which means the locks cannot become unassembled in the surgical field. The posterior side of the Quantum plates present texture to allow for osteointegration and is designed to allow the plate to absorb load that with traditional plates is fully on the screws. With the hyper angulation of the screw holes design, the surgeon has the option to place the screws as far away from adjacent levels as possible.”

As sister organizations within the Fountainhead Investment Partners portfolio, Nvision and Watershed have previously collaborated on other innovative projects, such as Structural Encoding and 3D printed wedges and interference screws.

“We understand that speed and efficiency in innovation within the industry is essential,” said Brian Kieser, Founding Partner of Fountainhead Investment Partners. “That is why we set up our organization in a way to allow the sister companies to operate independently, yet still allowing for collaborations on key initiatives to advance timelines around research and development. Because we share a fundamental core culture and infrastructure regarding quality, engineering, and process controls across all entities, we all speak the same language. We believe this structure drives greater innovation that ultimately translates into bringing safer, cutting-edge products to the market faster while reducing costs. Quantum is a perfect example of speed to market as the application of the technology from Watershed R&D to Nvision FDA clearance was less than 18 months.”

Nvision, founded in 2013, is quickly becoming the largest medical device manufacturer in San Antonio, with 21 FDA-cleared devices across a range of orthopedic specialties. In the last year, Nvision added seven products with FDA clearance to its portfolio, with an additional two currently in FDA review and two more scheduled for submission. Nvision has 18 issued patents with more than 30 in development.

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Andrea Gambini

Andrea has always loved reading and writing. He started working in an editorial office as a sports journalist in 2008, then the passion for journalism and for the world of communication in general, allowed him to greatly expand his interests, leading to several years of collaborations with several popular online newspapers. Andrea then approached 3D printing, impressed by the great potential of this new technology, which day after the day pushed him to learn more and more about what he considers a real revolution that will soon be felt in many fields of our daily life.

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