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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DevicePearlMatrix™ P-15 Peptide Enhanced Bone Graft (PearlMatrix™ Bone Graft)
Generic NameFiller, bone void, synthetic peptide
ApplicantCerapedics, Inc.
11025 Dover St., Suite 1600
Westminster, CO 80021
PMA NumberP240001
Supplement NumberS001
Date Received09/08/2025
Decision Date12/11/2025
Product Code NOX 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
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.
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