The market submission for CERAMENT® V in the US will be a 510(k)
Prenumeration
Beskrivning
| Land | Sverige |
|---|---|
| Lista | Mid Cap Stockholm |
| Sektor | Hälsovård |
| Industri | Medicinteknik |
BONESUPPORT™, a leading company in orthobiologics for the management of bone injuries, today announces that the company’s submission for marketing authorization for its antibiotic eluting bone graft substitute, CERAMENT V (vancomycin), following discussions with the U.S. Food and Drug Administration (FDA), will proceed through a 510(k) pathway, instead of a De Novo application.
The marketing approval for CERAMENT® G in 2022 was based on extensive efficacy and patient safety data, with nearly 17,000 clinical data points. Since CERAMENT V shares the same mechanism of action as CERAMENT G, despite containing a different antibiotic, CERAMENT G can serve as a predicate device for CERAMENT V. The submission is still scheduled for the first quarter of 2025.
CERAMENT V has previously received “breakthrough device” designation from the FDA for the indication bone infection.