PMA P000058S096

Device: Infuse Bone Graft
Applicant: Medtronic Sofamor Danek USA, Inc.
PMA number: P000058
Supplement: S096
Product code: NEK
Decision date: 2026-02-13
Classification: Orthopedic
Generic name: Filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction
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.

Current openFDA PMA Record#

Device: Infuse Bone Graft
Applicant: Medtronic Sofamor Danek USA, Inc.
PMA number: P000058
Supplement: S096
Product code: NEK
Generic name: Filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction
Decision date: 2026-02-13
Decision code: APPR
Date received: 2025-08-19
Supplement type: Panel Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
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.