Cerapedics has gained U.S. Food and Drug Administration (FDA) approval to expand the indications for use and labeling for its i-FACTOR P-15 peptide enhanced bone graft.
 
The label expansion approves i-FACTOR for single-level anterior cervical discectomy fusion (ACDF) with an allograft bone ring, or in conjunction with an FDA-cleared PEEK, titanium alloy, or PEEK/titanium fusion interbody device for use in the cervical spine, with supplemental anterior plate fixation.
 
ACDF is a surgery to reduce or remove pain due to neck issues like degenerative disc disease by removing a damaged sic and fusing the spinal vertebral bones above and below the disc. This creates spinal stability, as well as spinal decompression.
 
The fusion is achieved with a bone graft, which grows together with the vertebrae to form one bone. i-FACTOR is indicated for use in skeletally mature patients for reconstruction of a degenerated cervical disc at one level from C3-C4 to C6-C7.

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READ MORE: Cerapedics Files Final Module in PMA Application for P-15 Bone Graft

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i-FACTOR’s premarket approval (PMA) investigational device exemption (IDE) study was designed in 2005 using the standard for ACDF procedures at the time, an allograft ring. Cerapedics’ indication expansion responds to the evolving practice of medicine in the following years, the company stated.
 
The company said i-FACTOR can now be used with most commercial interbody cages.
 
“This label expansion approval is part of our deep commitment to bring scientific rigor to bone grafting so surgeons and the patients they treat have access to products with proven safety, efficacy and evidence,” said Valeska Schroeder, CEO of Cerapedics. “i-FACTOR has been a trusted choice in bone graft selection in the United States since 2015 as the only bone graft replacement FDA-approved for single-level ACDF procedures with a premarket approval based on a Level 1 human clinical trial. We are proud to have FDA approval for the safe and effective use of i-FACTOR in PEEK and titanium cages.”