PearlMatrix P-15 Peptide Enhanced Bone Graft (PearlMatrix Bone Graft)
FDA premarket approval P240001/S001 · decided 2025-12-11
Approval details
- PMA number
- P240001
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- PearlMatrix P-15 Peptide Enhanced Bone Graft (PearlMatrix Bone Graft)
- Generic name
- Filler, bone void, synthetic peptide
- Applicant
- Cerapedics, Inc.
- Date received
- 2025-09-08
- Decision date
- 2025-12-11
- Days to decision
- 94 days
- Decision code
- APPR
- Product code
- NOX
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Westminster, CO
- Statement
- Approval to allow implantation of the product using additional open or minimally invasive surgical approaches: ALIF (anterior lumbar interbody fusion), TLIF (transforaminal lumbar interbody fusion), PLIF (posterior lumbar interbody fusion), OLIF/ATP (oblique lumbar interbody fusion/anterior to psoas) and LLIF (lateral lumbar interbody fusion); and approval to allow use of the product with titanium alloy and PEEK/titanium interbody fusion cages, as well as the original PEEK interbody fusion cages
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