3D Systems enables FDA clearance for Walter Reed 3D-printed titanium cranial implant

DDD•2026-07-28

FDA clears Walter Reed titanium cranial plate system

The FDA has cleared the Walter Reed 3D Medical Applications Center Titanium Cranial Plate System, described as the first implant clearance granted to a point-of-care institution.

3D Systems said it supported the Defense Health Agency partnership on quality systems, validation, manufacturing workflow controls, device design and regulatory strategy.

The patient-specific titanium cranial plate is intended to treat traumatic head injuries in active-duty personnel worldwide.

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3D Systems enables FDA clearance for Walter Reed 3D-printed titanium cranial implant

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3D Systems enables FDA clearance for Walter Reed 3D-printed titanium cranial implant

FDA clears Walter Reed titanium cranial plate system

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3D Systems enables FDA clearance for Walter Reed 3D-printed titanium cranial implant

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