OssDsign’s nanosynthetic bone graft OssDsign Catalyst received FDA 510(k) clearance for use in interbody cages in spinal surgery, allowing surgeons to use OssDsign Catalyst on-label in any interbody cage cleared for use with synthetic bone grafts. OssDsign Catalyst is reported to be the first synthetic bone graft to be cleared to market for interbody use based on bone graft data alone.
Catalyst is designed to stimulate the formation of healthy bone tissue in spinal fusion. The extended FDA clearance of OssDsign Catalyst is based on its bone regeneration results, which surpass those typically seen with other synthetic bone grafts in challenging evaluation models.
OssDsign continues to accelerate a robust program of gathering clinical evidence for OssDsign Catalyst anchored by PROPEL, a U.S.-based multicenter prospective spinal fusion registry in which more than 200 patients are enrolled, and the clinical study TOP FUSION, in which patient enrolment was completed in April 2022.
“As there is a huge demand for interbody use of synthetic bone grafts, believed to represent as much as 50% of all bone graft usage in spine surgeries, the new clearance marks a major market opportunity and sets us up for further commercial acceleration. The FDA clearance is based on our compelling data and it clearly strengthens and differentiates us in the market,” said Morten Henneveld, CEO of OssDsign.
OssDsign's nanosynthetic bone graft OssDsign Catalyst received FDA 510(k) clearance for use in interbody cages in spinal surgery, allowing surgeons to use OssDsign Catalyst on-label in any interbody cage cleared for use with synthetic bone grafts. OssDsign Catalyst is reported to be the first synthetic bone graft to be cleared to market for...
OssDsign’s nanosynthetic bone graft OssDsign Catalyst received FDA 510(k) clearance for use in interbody cages in spinal surgery, allowing surgeons to use OssDsign Catalyst on-label in any interbody cage cleared for use with synthetic bone grafts. OssDsign Catalyst is reported to be the first synthetic bone graft to be cleared to market for interbody use based on bone graft data alone.
Catalyst is designed to stimulate the formation of healthy bone tissue in spinal fusion. The extended FDA clearance of OssDsign Catalyst is based on its bone regeneration results, which surpass those typically seen with other synthetic bone grafts in challenging evaluation models.
OssDsign continues to accelerate a robust program of gathering clinical evidence for OssDsign Catalyst anchored by PROPEL, a U.S.-based multicenter prospective spinal fusion registry in which more than 200 patients are enrolled, and the clinical study TOP FUSION, in which patient enrolment was completed in April 2022.
“As there is a huge demand for interbody use of synthetic bone grafts, believed to represent as much as 50% of all bone graft usage in spine surgeries, the new clearance marks a major market opportunity and sets us up for further commercial acceleration. The FDA clearance is based on our compelling data and it clearly strengthens and differentiates us in the market,” said Morten Henneveld, CEO of OssDsign.
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