Tissue Regeneration Systems, Inc. ("TRS") today announced that it has received 510K approval from the U.S. Food and Drug Administration 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 novel skeletal reconstruction and bone regeneration technology platform.
The 510K approval process required TRS to meet a high standard of pre-clinical testing and successfully pass a rigorous review by the FDA. "This is a significant milestone for the company," said Jim Fitzsimmons, president and chief executive officer. "With our base material and manufacturing processes now cleared by FDA, the approval pathway for future products can be streamlined," he added. TRS has filed a 510K for its second product, which is currently being reviewed by FDA. Other submissions are in work, according to Fitzsimmons.