PearlMatrix Bone Graft
FDA premarket approval P240001 · decided 2025-06-18
Approval details
- PMA number
- P240001
- Trade name
- PearlMatrix Bone Graft
- Generic name
- Filler, bone void, synthetic peptide
- Applicant
- Cerapedics, Inc.
- Date received
- 2024-01-02
- Decision date
- 2025-06-18
- Days to decision
- 533 days
- Decision code
- APPR
- Product code
- NOX
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Westminster, CO
- Statement
- PearlMatrix Bone Graft is indicated for intervertebral body fusion of the spine in skeletally mature patients. PearlMatrix Bone Graft is intended to be used in conjunction with a PEEK TLIF Fusion Device and supplemental internal spinal fixation systems cleared by the FDA for use in the lumbosacral spine. The system is to be used in patients who have had at least six months of non-operative treatment. PearlMatrix Bone Graft is intended for use at one level in the lumbar spine (L2-S1) for the t
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