- Collaboration with Defense Health Agency (DHA) enables Walter Reed 3D Medical Application Center (3D MAC) to achieve first FDA-cleared medical device
- First-ever FDA clearance for an implant granted to a point-of-care institution
- Reinforces 3D Systems’ leadership in guiding healthcare partners from concept to regulatory clearance and commercialization of 3D-printed, patient-specific devices
ROCK HILL, S.C., July 28, 2026 (GLOBE NEWSWIRE) — Today, 3D Systems (NYSE: DDD) announced its role in enabling the Defense Health Agency (DHA) and the Walter Reed National Military Medical Center’s 3D Medical Applications Center (3D MAC) to achieve U.S. Food and Drug Administration (FDA) premarket clearance for the 3D MAC Titanium Cranial Plate (TCP) System, the first-ever FDA-cleared implant granted to a point-of-care institution. 3D MAC’s patient-specific Titanium Cranial Plate (TCP) will be used to treat U.S. active duty personnel and war fighters suffering from traumatic head injuries around the world.
Advancing Point-of-Care Manufacturing Through Collaboration
This milestone represents the culmination of a multi-year collaboration between 3D Systems and 3D MAC to advance additive manufacturing in clinical environments. The 3D Medical Applications Center, based at Walter Reed National Military Medical Center, specializes in patient-specific anatomical models, surgical guides, and implants to support personalized care for service members and veterans.
“We believe point-of-care manufacturing is transforming the future of healthcare by bringing personalized medical devices closer to the patient. Our unique collaborations with the U.S. Defense Health Agency and the Department of Veterans Affairs underscore our leadership in this space and reinforce our commitment to expanding this business as a long-term growth driver for 3D Systems.” said Jeff Graves, President and CEO of 3D Systems.
Throughout the engagement, 3D Systems worked closely with 3D MAC to establish a robust quality management system (QMS) and provided support across the full development lifecycle, from design and validation through regulatory submission. The FDA clearance of the Titanium Cranial Plate System marks 3D MAC’s first-ever FDA-cleared medical device.
Enabling Regulatory Readiness and Clinical Innovation
3D Systems provided expertise in process controls, device design optimization, additive manufacturing workflows, and regulatory strategy to support 3D MAC in achieving premarket clearance. This collaboration enabled the transition from concept to an FDA-cleared implant manufactured at the point-of-care.
Natalie Byrnes, Manager of Product Development – Patient Specific Medical Technology, 3D Systems said “This clearance underscores the power of combining clinical innovation with deep expertise in additive manufacturing and regulatory compliance. We are honored to help enable expanded access to personalized care delivered at the point of treatment.”
Industry Leadership and Future Opportunities
The clearance establishes multiple industry firsts, including the first FDA-cleared implant granted to a point-of-care institution and 3D MAC’s first FDA-cleared medical device. It reinforces 3D Systems’ leadership in enabling point-of-care manufacturing and highlights its ability to help healthcare institutions navigate the path from concept through regulatory clearance and commercialization.
This achievement further strengthens 3D Systems’ relationships with the Defense Health Agency and the Department of Veterans Affairs and positions the company to support future initiatives in advanced, patient-specific medical manufacturing.
The clearance is listed on the FDA website under submission number K253116.
About 3D Systems
For 40 years Chuck Hull’s curiosity and desire to improve the way products were designed and manufactured gave birth to 3D printing, 3D Systems, and the additive manufacturing industry. Since then, that same spark continues to ignite the 3D Systems team as we work side-by-side with our customers to change the way industries innovate. As a full-service solutions partner, we deliver industry-leading 3D printing technologies, materials and software to high-value markets such as medical and dental; aerospace, space and defense; transportation and motorsports; AI infrastructure; and durable goods. Each application-specific solution is powered by the expertise and passion of our employees who endeavor to achieve our shared goal of Transforming Manufacturing for a Better Future. More information on the company is available at www.3dsystems.com.
Forward-Looking
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