PearlMatrix P-15 Peptide Enhanced Bone Graft

FDA PMA

Class III (US FDA PMA)

PMA P240001

by Cerapedics, LLC

Identity

Trade Name: PearlMatrix Bone Graft FDA PMA
Generic Name: Filler, bone void, synthetic peptide FDA PMA

Identifiers

PMA Number: P240001 FDA PMA
FDA Product Code: NOX FDA PMA

Classification

Device Class: Class III FDA PMA
Advisory Committee: Orthopedic FDA PMA
FDA Decision: APPR Approved FDA PMA

PearlMatrix P-15 Peptide Enhanced Bone Graft is a synthetic peptide bone void filler indicated for intervertebral body fusion of the spine in skeletally mature patients with degenerative disc disease. It is designed to be used in conjunction with a PEEK TLIF Fusion Device and supplemental internal spinal fixation systems for lumbar spine fusion at one level (L2-S1) with up to Grade I spondylolisthesis.

The device is supplied as a sterile, single-use product and is intended for patients who have undergone at least six months of non-operative treatment. It is classified as a Class III medical device with FDA PMA authorization and is manufactured by Cerapedics, LLC in Westminster, Colorado.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Cerapedics Announces FDA Approval of PearlMatrix™ P-15 Peptide Enhanced Bone Graft, The First and Only Proven Bone Growth Accelerator for Lumbar Fusion | Cerapedics Corporate, Cerapedics' PearlMatrix P-15 Peptide Enhanced Bone Graft, The First and Only Proven Bone Growth Accelerator, Now Approved for Expanded Indications for Use, P-15 | Cerapedics Corporate, Cerapedics’ PearlMatrix P-15 Peptide Enhanced Bone Graft, The First and Only Proven Bone Growth Accelerator, Now Approved for Expanded Indications for Use | Cerapedics Corporate

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

Source	Region	Type	Cert / Approval No.	Class	Status
FDA PMA	United States	FDA_PMA	P240001	Class III	Active

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Manufacturer

Manufacturer: Cerapedics, LLC
FDA Applicant: Cerapedics, Inc.

Sources (1)

FDA PMA P240001 23 fields · synced Sep 18, 2026