Prosidyan’s synthetic bone graft substitute receives FDA clearance: 4 things to note

Prosidyan, a Warren, N.J.-based developer of fiber-based bioactive glass products, received FDA 510(k) clearance for its FIBERGRAFT BG Morsels for postero-lateral spinal fusion.

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Here are four things to note:

 

1. Composed of 45S5 bioactive glass microfibers and microspheres, the FIBERGRAFT BG Morsels are designed to enhance biological response.

 

2. The morsels are intended for placement in bony voids of the skeletal system.

 

3. FIBERGRAFT BG Morsels are used with autogenous bone marrow aspirate, an autograft in the postero-lateral spine.

 

4. The technology involves the bioactive glass fibers establishing direct connectivity.

 

“With FIBERGRAFT, we now finally have the next generation of synthetic bone grafting for spine,” said Hyun Bae, MD, chief medical officer of Prosidyan. “Synthetic bone grafts have been stagnant for twenty years using the same porous technology.”

 

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