Medical devices developer Tissue Regeneration Systems has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its new Cranial Bone Void Filler product designed for repair of neurosurgical burr holes.
The new product, which marks the company’s first of a family of craniomaxillofacial surgery products, is based on novel skeletal reconstruction and bone regeneration technology platform.
Tissue Regeneration Systems president and CEO Jim Fitzsimmons said this is the first FDA approval of a coated bioresorbable skeletal reconstruction implant fabricated by means of 3D printing.
"Our base material and manufacturing processes now cleared by FDA, the approval pathway for future products can be streamlined," Fitzsimmons added.
FDA is also currently reviewing a 510K filed by the company for its second product.
In addition, the company is developing advanced skeletal reconstruction implants with exclusive attributes using a technology platform developed at the Universities of Michigan and Wisconsin.
The company said these implants are bioresorbable over time and can fully replace themselves with natural bone.
The advanced implants do not require metal plates for reinforcement and its structural integrity permits its usage as an alternative to bone harvested from the patient for complex skeletal reconstruction.
Bone regeneration can also be enhanced by integrating these implants with a proprietary osteoconductive coating.