PMA P240001S001

Device: PearlMatrix™ P-15 Peptide Enhanced Bone Graft (PearlMatrix™ Bone Graft)
Applicant: Cerapedics, Inc.
PMA number: P240001
Supplement: S001
Product code: NOX
Decision date: 2025-12-11
Classification: Orthopedic
Generic name: Filler, bone void, synthetic peptide
Approval order 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.

Current openFDA PMA Record#

Device: PearlMatrix™ P-15 Peptide Enhanced Bone Graft (PearlMatrix™ Bone Graft)
Applicant: Cerapedics, Inc.
PMA number: P240001
Supplement: S001
Product code: NOX
Generic name: Filler, bone void, synthetic peptide
Decision date: 2025-12-11
Decision code: APPR
Date received: 2025-09-08
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order 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.