---
title: "3D Systems enables first FDA-cleared implant from a point-of-care institution"
url: https://www.voxelmatters.com/3d-systems-enables-first-fda-cleared-implant-from-a-point-of-care-institution/
date: 2026-07-31
modified: 2026-07-31
lang: en
author: "Joseph Caron-Dawe"
description: "The Defense Health Agency (DHA) and Walter Reed National Military Medical Center's 3D Medical Applications Center (3D MAC) have received U.S. Food and Drug Administration (FDA) premarket clearance for the..."
categories:
  - "Medical AM"
  - "Orthopedic Implants"
tags:
  - "future"
image: https://www.voxelmatters.com/wp-content/uploads/2026/07/3D-Systems-Walter-Reed-640x443.jpg
word_count: 330
---

# 3D Systems enables first FDA-cleared implant from a point-of-care institution

The Defense Health Agency (DHA) and Walter Reed National Military Medical Center's 3D Medical Applications Center (3D MAC) have received U.S. Food and Drug Administration (FDA) premarket clearance for the 3D MAC Titanium Cranial Plate (TCP) System.

It marks the first [FDA-cleared implant](https://www.voxelmatters.com/3d-systems-achieves-510k-clearance-for-peek-cranial-implants/) granted to a point-of-care institution, claimed [3D Systems](https://www.voxelmatters.directory/company/3d-systems/), and the patient-specific implant will be used to treat U.S. active duty personnel and service members suffering from traumatic head injuries.

![3D Systems appoints Jeffrey Creech as Executive VP and Chief Financial Officer and Harriss Currie as President of Regenerative Medicine.](https://www.voxelmatters.com/wp-content/uploads/2023/03/3d-systems-1-340x227.png)

3D Systems worked with 3D MAC on the device over a multi-year collaboration aimed at advancing additive manufacturing in clinical settings. The 3D Medical Applications Center, based at Walter Reed National Military Medical Center, produces patient-specific anatomical models, surgical guides and implants for service members and veterans. The clearance marked 3D MAC's first FDA-cleared medical device.

## Building a regulatory pathway

3D Systems said it provided expertise in process controls, device design optimization, additive manufacturing workflows and regulatory strategy to support 3D MAC through the clearance process, covering design, validation and regulatory submission. The company also worked with 3D MAC to establish a quality management system for the program.

“We believe point-of-care manufacturing is transforming the future of healthcare by bringing personalized medical devices closer to the patient,” said Jeff Graves, President and Chief Executive Officer at 3D Systems.

“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.”

## Company points to broader point-of-care push

3D Systems said the clearance strengthens its relationships with the DHA and the Department of Veterans Affairs and [positions the company to support further point-of-care medical manufacturing initiatives](https://www.voxelmatters.com/3d-systems-achieves-fda-510k-clearance-for-vsp-orthopedics/).

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

“We are honored to help enable expanded access to personalized care delivered at the point of treatment.”