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FDA Approves OSSDsign’s 3D Printed Cranial Implant

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The FDA has approved OSSDsign’s new cranial implant that uses an innovative and patented composite material printed to exact patient needs with a 3D printer.

The Uppsala, Sweden-based designer, manufacturer and distributor constructs individually designed and printed cranial implants using the patient’s computer tomography (CT) information. The OssDsign system combines advanced computer-assisted design (CAD) with a proprietary calcium phosphate composite as a 3D printing material, which is reinforced by a titanium skeleton.

The calcium phosphate material promotes osseointegration, which means the patient’s own skull bone bonds directly with the implant. This reduces common complications that can occur with other materials such as PEEK and titanium, which are inert and do not easily bind with bone. Such complications including infections, sometimes necessitate removal of the implant and further surgery.

The innovative OssDsign’s cranial implant has been used in Scandinavia and several European countries since 2014.

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20 Feb, 17



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