FDA approves Cranial Bone Void Filler repair system
Tissue Regeneration Systems has received 510(K) approval from the FDA for its Cranial Bone Void Filler product, indicated for use in the repair of neurosurgical burr holes. The company's biodegradable polymer mesh implant can bear load and are strong enough to support function without need for reinforcement with metal plates. Their geometry can be custom constructed using 3D printing.
Finally, they are integrated with a proprietary, osteoconductive coating that serves as an excellent substrate for adhesion and local, controlled release of growth factors to enhance bone regeneration.
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