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Cerapedics gained FDA approval for an expansion to the indications for use and labeling for i-FACTOR P-15 Peptide Enhanced Bone Graft. With this label expansion, i-FACTOR is now approved for single-level anterior cervical discectomy fusion (ACDF) with an allograft bone ring, or in conjunction with a PEEK, titanium alloy or PEEK/titanium fusion interbody device cleared by FDA for use in the cervical spine, and with supplemental anterior plate fixation.
The premarket approval (PMA) investigational device exemption (IDE) study for i-FACTOR was designed in 2005, using the gold standard for ACDF procedures at that time – an allograft ring. The practice of medicine has evolved in the subsequent years, and this indication expansion underscores Cerapedics’ commitment to invest in evidence that supports clinical practice and meets the needs of our physician customers. i-FACTOR can now be used with most interbody cages on the market providing proven safety and fusion efficacy through human clinical data.
“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, Chief Executive Officer 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.”
Source: Cerapedics
Cerapedics gained FDA approval for an expansion to the indications for use and labeling for i-FACTOR P-15 Peptide Enhanced Bone Graft. With this label expansion, i-FACTOR is now approved for single-level anterior cervical discectomy fusion (ACDF) with an allograft bone ring, or in conjunction with a PEEK, titanium alloy or PEEK/titanium fusion...
Cerapedics gained FDA approval for an expansion to the indications for use and labeling for i-FACTOR P-15 Peptide Enhanced Bone Graft. With this label expansion, i-FACTOR is now approved for single-level anterior cervical discectomy fusion (ACDF) with an allograft bone ring, or in conjunction with a PEEK, titanium alloy or PEEK/titanium fusion interbody device cleared by FDA for use in the cervical spine, and with supplemental anterior plate fixation.
The premarket approval (PMA) investigational device exemption (IDE) study for i-FACTOR was designed in 2005, using the gold standard for ACDF procedures at that time – an allograft ring. The practice of medicine has evolved in the subsequent years, and this indication expansion underscores Cerapedics’ commitment to invest in evidence that supports clinical practice and meets the needs of our physician customers. i-FACTOR can now be used with most interbody cages on the market providing proven safety and fusion efficacy through human clinical data.
“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, Chief Executive Officer 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.”
Source: Cerapedics
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Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.
