PearlMatrix P-15 Peptide Enhanced Bone Graft (Cerapedics)

PearlMatrix P-15 Peptide Enhanced Bone Graft is a **Class III drug-device combination product** developed by Cerapedics for use in **single-level transforaminal lumbar interbody fusion (TLIF)** procedures. It is the **first and only bone growth accelerator proven to accelerate lumbar fusion** with statistically superior fusion speed compared to local autograft. The active component is **P-15 Peptide**, a 15-amino acid sequence found naturally in Type-1 collagen, the predominant protein in bone. This pharmaceutically manufactured peptide is bound onto **calcium phosphate particles** and incorporated into a **collagen matrix carrier**, creating a P-15-enhanced scaffold that provides abundant attachment sites for osteogenic (bone-forming) cells. The mechanism involves cell attachment, activation of pathways that release cell-signaling growth factors, and acceleration of new bone formation through natural cellular processes. The product received **FDA premarket approval (PMA)** in June 2025 and was granted **Breakthrough Device designation** in April 2021. It is indicated for intervertebral body fusion of the spine in skeletally mature patients with degenerative disc disease (DDD) at one level in the lumbar spine (L2-S1), used in conjunction with a PEEK TLIF Fusion Device and supplemental internal spinal fixation systems. Clinical evidence from the ASPIRE pivotal study (293 patients, 33 U.S. centers, ~60% high-risk patients) demonstrated statistically superior fusion speed with over twice as many patients fused at six months versus local autograft.

Brand names

PearlMatrix

Other names

PearlMatrix Bone GraftPearlMatrix P-15