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# Cerapedics PMA Supplement OK’d for Bone Graft
- URL: https://www.fdaweb.com/cerapedics-pma-supplement-okd-for-bone-graft/
- Published: 2019-11-18T12:00:00.000Z
- Updated: 2026-09-14T15:53:28.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5145528

FDA has approved a Cerapedics PMA supplement for i-FACTOR Peptide Enhanced Bone Graft in anterior cervical discectomy and fusion procedures in patients with degenerative cervical disc disease. Cerapedics’ submission requested approval for an updated package insert that incorporates the 24-month follow-up data from subjects enrolled in the original clinical study. The approval allows i-FACTOR’s labeling to reflect longer-term clinical data showing that the statistical superiority to autologous bone in overall clinical success that was observed at one year has been maintained at two-year follow up, the company says.

Cerapedics began marketing the bone graft in 2016\. The drug-device combination is based on synthetic small peptide (P-15) technology that “accelerates new bone formation in patients with degenerative disc disease,” the company says.