Rebecca Kern, The Gray Sheet
Multiple companies have recently used 3-D printing to make implantable devices t hat are customized to specific patients or to improve manu facturing precision
and efficiency. The current activity could be a first step toward establishing a new paradigm of personalized implants, FDA and others suggest.
One initial foray into 3-D printed implants has been for craniamaxillofacial reconstruction products to fill voids in the skull. Tissue Regeneration Systems Inc., founded in 2008, gained 510(k) clearance this August for the first of several planned products - its cranial bone void filler used to repair neurosurgical burr holes. The product is made by 3-D printing a bioresorbable polymer (PCL) that is porous and osteoconductive. The implant is covered wit h a coating to promote bone growth so that it will fully degrade within two to three years.
"To our knowledge, this is the first FDA approval of a coated bioresorbable skeletal reconstruction implant fabricated by means of 3-D printing," TRS President and CEO Jim Fitzsimmons said in an interview.
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