Amnovis, a contract manufacturer focused on 3D printed medical devices, has marked its fifth anniversary with the delivery of its 100,000th 3D printed implant.
Founded in June 2020 by Peter Mercelis and Ruben Wauthle, the company combines quality, regulatory compliance, and timely delivery for key industries. “From day one, we wanted Amnovis to be more than just another supplier,” said Ruben Wauthle, CEO and Co-founder. “We set out to build a company that consistently delivers high-quality parts, communicates transparently, and meets deadlines. Five years later, we’re proud to say we’re doing exactly that.”
Promethean Restorative’s FDA-Approved SI Fixation Implant.
Expansion and Industry Diversification
The company reports a customer acceptance rate above 99.9% and on-time delivery exceeding 90% over the past three years. The 100,000th part produced was Promethean Restorative’s FDA-cleared SI fixation device, manufactured as part of its product launch.
According to Glenn Bowman, President & CEO of Promethean Restorative, Amnovis’s use of an FDA Master File helped streamline regulatory approval: “It accelerated our go-to-market timeline and reduced regulatory friction. Their clarity in documentation and speed in execution helped us avoid delays and maintain momentum.”
Amnovis anticipates producing over 50,000 implants in 2025, nearly half of its five-year total output. To support this growth, it is expanding production capacity and extending its operations into sectors such as aerospace, semiconductor manufacturing, and advanced engineering components.
Promethean Restorative’s FDA-Approved SI Fixation Implant. Image via Amnovis.
Advancing Metal Additive Manufacturing
Beyond 3D printed implants, one of Amnovis’s latest innovations, heat-treatment-free titanium, meets ASTM standards without requiring additional post-processing and is already being used in spinal, orthopedic, and cranio-maxillofacial implants. The company has also developed a deformable implant concept that enables patient-specific customization by reshaping porous sections of standardized components.
Manufacturing on Demand
Additionally, CuperNova, Amnovis’s proprietary powder modification process, enhances the laser absorptivity, flowability, and shelf life of copper alloys, allowing them to be processed with standard laser systems. The company is currently scaling this method for industrial applications, while its ongoing multi-metal 3D printing research explores combining two or more metals using laser powder bed fusion (L-PBF) to enable new material capabilities.
“As we look ahead, we’re excited about the opportunities to scale our impact even further,” Wauthle said. “We’re building on a foundation of quality and reliability while continuing to turn advanced ideas into practical solutions for our customers.”
Innovations in 3D Printed Implants
In September, researchers at Sungkyunkwan University, led by Professor Jung Seung Lee, developed a handheld 3D printing device capable of producing biodegradable bone implants directly at the site of injury. Tested in rabbits with large bone defects, the approach provided structural support while encouraging stronger, more natural bone growth, although adhesion and long-term strength remain areas for further improvement. Unlike prefabricated implants or bone cement, which must be shaped in advance, the printed material adapts to the unique geometry of each injury.
Elsewhere, a team from Zhejiang University and Taizhou University, led by Liwen Zhang, created 3D printed bone fixation implants combining structural support with targeted antibiotic delivery. Using stereolithography (SLA), the researchers fabricated customized bone nails from dental resin composites infused with ceftriaxone sodium, an antibiotic commonly used to prevent infections during surgery. The study addresses common limitations in orthopedic implants, demonstrating devices that both support bone healing and help control infection. The implants were produced using commercially available Anycubic Photon and Mono X 3D printers, illustrating the potential of accessible, customizable manufacturing in medical settings.
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Author: Paloma Duran
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