3D printing technology has helped replace 75 percent of a patient's skull with the approval of U.S. regulators.
The 3D-printed implant can replace the bone in people's skulls damaged by disease or trauma, according to Oxford Performance Materials. The company announced it had received approval from the U.S. Food and Drug Administration for its skull implant on Feb. 18 — a decision that led to the first U.S. surgical operation on March 4.
"We see no part of the orthopedic industry being untouched by this," said Scott DeFelice, president of Oxford Performance Materials.
DeFelice's company is already selling 3D-printed implants overseas as a contract manufacturer. But the FDA decision has opened the door for U.S. operations using the implants. [Video: A 3D Printer of Your Own]
3D printing's advantage comes from taking the digitally scanned model of a patient's skull and "printing" out a matching 3D object layer by layer. The precise manufacturing technique can even make tiny surface or edge details on the replacement part that encourage the growth of cells and allow bone to attach more easily.
About 300 to 500 U.S. patients could use skull bone replacements every month, according to DeFelice. The possible patients include people with cancerous bone in their skulls, as well as car accident victims and U.S. military members suffering from head trauma.
Major First! FDA Grants First 3D Printed Implant Clearance
The FDA has, for the first time, awarded its 510(k) clearance for an additively manufactured polymer implant. The product, called the OsteoFab Patient Specific Cranial Device (OPSCD), is manufactured by Oxford Performance Materials (OPM) of South Windsor, Connecticut.
“OsteoFab” is OPM’s brand for additively manufactured medical and implant parts produced from PEKK (polyetherketoneketone) polymer. OPM’s process (also called “3D Printing”), “grows” implants layer by layer directly from a digital CAD file without the aid of tooling. Company officials say that there are few practical limits on what can be produced. As such, the OsteoFab technology is ideal for one-of-a kind implants specifically shaped to each patient’s anatomy. One desirable use of patient specific implants, and the motivation for the OPSCD, is cranial implants to replace bony voids in the skull due to trauma or disease.
The cranial implant (OPSCD) is manufactured from PEKK, an ultra high performance polymer used in biomedical implants. OPM had traditionally sold PEKK as a raw material or in a semi-finished form, but began developing additive manufacturing technologies in 2006. In 2011, OPM established a biomedical compliant manufacturing facility in South Windsor, to support its growing additive manufacturing business. As an implantable polymer, PEKK is biocompatible, mechanically similar to bone, and radiolucent so as not to interfere with X-Ray equipment. OPM has recently completed testing which, it says, confirms that the OsteoFab implant surface is osteoconductive.
“It is our firm belief that the combination of PEKK and additive manufacturing (our OsteoFab technology) is a highly transformative and disruptive technology platform that will substantially impact all sectors of the orthopedic industry,” said Scott DeFelice, President and CEO of OPM. “We have sought our first approval within cranial implants because the need was most compelling; however, this is just the beginning. We will now move systematically throughout the body in an effort to deliver improved outcomes at lower overall cost to the patient and healthcare provider.” DeFelice said that OPM’s strategy is to undertake all manufacturing and regulatory activities to support patient specific implant product commercialization.
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