3D Systems协助Walter Reed 3D MAC取得首个院内即时制造植入物FDA 510(k)许可

<span>3D Systems Enables First FDA Clearance for Implant from a Point-of-Care Institution</span>

<span><span>Elizabeth Piet</span></span>

<span><time datetime="2026-07-27T14:00:48-04:00" title="Monday, July 27, 2026 - 14:00">Mon, 07/27/2026 - 14:00</time>
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Wednesday, Jul 28, 2027 7:00 AM
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<ul><li>Collaboration with Defense Health Agency (DHA) enables Walter Reed 3D Medical Application Center (3D MAC) to achieve first FDA-cleared medical device&nbsp;</li><li>First-ever FDA clearance for an implant granted to a point-of-care institution</li><li>Reinforces 3D Systems’ leadership in guiding healthcare partners from concept to regulatory clearance and commercialization of 3D-printed, patient-specific devices</li></ul><p><strong>ROCK HILL, South Carolina, July 28, 2026</strong> – Today,&nbsp;<a href="https://www.3dsystems.com">3D Systems</a> (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.&nbsp;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.&nbsp;</p><p><strong>Advancing Point-of-Care Manufacturing Through Collaboration</strong></p><p>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.</p><p>“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.</p><p><strong>Enabling Regulatory Readiness and Clinical Innovation</strong></p><p>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.</p><p>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.”</p><p><strong>Industry Leadership and Future Opportunities</strong></p><p>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.</p><p>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.</p><p>The clearance is listed on the FDA website under submission number&nbsp;<a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253116">K253116</a>.</p><p><strong>About 3D Systems</strong></p><p>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&nbsp;<a href="https://www.3dsystems.com"><strong>www.3dsystems.com</strong></a>.</p><p><strong>Forward-Looking&nbsp;Statements</strong></p><p>Certain statements made in this release that are not statements of historical or current facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 including statements regarding the timing of product launches, regulatory approvals, market opportunities, expected revenue impact, and shareholder value. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of the company to be materially different from historical results or from any future results or projections expressed or implied by such forward-looking statements. In many cases, forward-looking statements can be identified by terms such as "believes," "belief," "expects," "may," "will," "estimates," "intends," "anticipates" or "plans" or the negative of these terms or other comparable terminology. Forward-looking statements are based upon management’s beliefs, assumptions, and current expectations and may include comments as to the company’s beliefs and expectations as to future events and trends affecting its business and are necessarily subject to uncertainties, many of which are outside the control of the company. The factors described under the headings "Forward-Looking Statements" and "Risk Factors" in the company’s periodic filings with the Securities and Exchange Commission, as well as other factors, could cause actual results to differ materially from those reflected or predicted in forward-looking statements. Although management believes that the expectations reflected in the forward-looking statements are reasonable, forward-looking statements are not, and should not, be relied upon as a guarantee of future performance or results, nor will they necessarily prove to be accurate indications of the times at which such performance or results will be achieved. The forward-looking statements included are made only as of the date of the statement. 3D Systems undertakes no obligation to update or review any forward-looking statemen