Approval covers the use of Infuse in the TLIF (transforaminal lumbar interbody fusion) procedures at one or two levels from L2-S1. It works with both PEEK and titanium interbody cages.

Medtronic said in a news release that the approval expands Infuse’s versatility by making it the only growth factor bone graft with PMA for ALIF, OLIF and now TLIF procedures. It also marks the first approval for a growth factor bone graft for spine fusion, including 2-level constructs for TLIF.

Infuse for TLIF initially received FDA breakthrough device designation in April 2024. Medtronic cleared another hurdle on the path toward this approval in July 2025, when, following the first interim analysis, the independent Data Monitoring Committee (DMC) determined that the company’s FDA investigational device exemption (IDE) study of Infuse for TLIF procedures met the predefined criteria for early success.