Cerapedics earned FDA approval to expand the use of its spinal fusion biologic, i-Factor P-15, according to a Sept. 24 news release.
Indications for the peptide enhanced bone graft now include single-level anterior cervical discectomy fusion with an allograft bone ring. It can also be used in conjunction with a PEEK titanium alloy or fusion device that has been cleared by the FDA for cervical spine use.
The i-Factor bone graft has been used in the U.S. since 2015, Cerapedic CEO Valeska Schroeder said in the release. It is reportedly the only product of its kind that used a P-15 osteogenic cell binding peptide, and studies show it is as safe as a local autograft in single-level ACDF.