FDA Gives Thumbs Up to 3-D Printed Bone Void Filler
In late August, Ann Arbor, Mich.-based Tissue Regeneration Systems Inc. (TRS) received 510(k) approval from the U.S. Food and Drug Administration (FDA) for its cranial bone void filler product, indicated for use in the repair of neurosurgical burr holes. This is first of a family of craniomaxillofacial surgery products being developed by TRS that incorporate the company’s skeletal reconstruction and bone regeneration technology platform.
“This is a significant milestone for the company,” said Jim Fitzsimmons, president and CEO of TRS. “With our base material and manufacturing processes now cleared by FDA, the approval pathway for future products can be streamlined.”
TRS has filed a 510(k) for its second product, which is currently being reviewed by the regulatory agency. Other submissions are in work, according to Fitzsimmons.
Applying a technology platform created at the Universities of Michigan and Wisconsin, TRS is developing advanced skeletal reconstruction implants with unique attributes. They are designed to be bioresorbable over time, fully replacing themselves with natural bone. Although their micro-architecture is porous to facilitate bone integration, they can bear load and reportedly strong enough to support function without need for reinforcement with metal plates. This structural integrity allows them to be used as an alternative to bone harvested from the patient for complex skeletal reconstruction. Using input from patient CT (computed tomography) scans, their geometry can be custom constructed. They are also integrated with a proprietary, osteoconductive coating that serves as a substrate for adhesion and local, controlled release of growth factors to enhance bone regeneration.
“To our knowledge, this is first FDA approval of a coated bioresorbable skeletal reconstruction implant fabricated by means of 3-D printing,” added Fitzsimmons. “This technology is definitely the wave of the future.”