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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.
 
DeviceInfuse Bone Graft
Generic NameFiller, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction
ApplicantMedtronic Sofamor Danek USA, Inc.
1800 Pyramid Pl.
Memphis, TN 38132
PMA NumberP000058
Supplement NumberS096
Date Received08/19/2025
Decision Date02/13/2026
Product Code NEK 
Advisory Committee Orthopedic
Clinical TrialsNCT04073563
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Infuse™ Bone Graft with an FDA cleared intervertebral body fusion device and metallic screw-and-rod system is indicated for use in a transforaminal lumbar interbody fusion (TLIF) surgical approach at one or two adjacent levels from L2-S1 in the treatment of symptomatic degenerative disc disease (DDD) confirmed by patient history and radiographic studies and having at least six months of nonoperative treatment attempted prior to treatment with Infuse™ Bone Graft.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
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