3D Systems (NYSE: DDD) announced it assisted the Defense Health Agency and Walter Reed National Military Medical Center's 3D Medical Applications Center (3D MAC) in obtaining U.S. Food and Drug Administration premarket clearance for the 3D MAC Titanium Cranial Plate System.

According to a company statement, the clearance marks the first time the FDA has granted implant clearance to a point-of-care institution. The FDA clearance is listed under submission number K253116.

The patient-specific titanium cranial plate is intended to treat active duty U.S. military personnel and service members with traumatic head injuries. 3D MAC is based at Walter Reed National Military Medical Center and focuses on patient-specific anatomical models, surgical guides, and implants for service members and veterans.

3D Systems said it supported 3D MAC throughout the development process, including establishing a quality management system and providing guidance on device design, additive manufacturing workflows, process controls, and regulatory strategy leading to the FDA submission.

Jeff Graves, President and CEO of 3D Systems, said the company's collaborations with the Defense Health Agency and the Department of Veterans Affairs reflect its focus on point-of-care manufacturing as "a long-term growth driver."

Natalie Byrnes, Manager of Product Development for Patient Specific Medical Technology at 3D Systems, said the clearance "underscores the power of combining clinical innovation with deep expertise in additive manufacturing and regulatory compliance."