Medtronic Receives FDA Approval for Infuse Bone Graft in TLIF Spine Procedures

Medtronic announced U.S. Food and Drug Administration premarket approval for the use of Infuse Bone Graft in Transforaminal Lumbar Interbody Fusion (TLIF) procedures at one or two levels from L2–S1, with both PEEK and titanium interbody cages. The FDA approved the application on February 13, 2026.

The approval expands the versatility of Infuse, making it the only PMA-approved growth factor bone graft for ALIF, OLIF, and now TLIF. It also marks the first approval for a growth factor bone graft for spine fusion, including 2-level constructs for TLIF.

The TLIF indication for Infuse received FDA Breakthrough Device Designation in April 2024, recognizing its potential to offer more effective treatment options for patients with degenerative lumbar spine conditions. This designation supported enhanced FDA engagement and contributed to a prioritized review timeline. Medtronic submitted a panel-track PMA application on August 18, 2025. The FDA approved the application 180 days later, underscoring the strength and quality of the clinical evidence supporting Infuse for TLIF.

The PMA approval is supported by a prospective, multicenter, randomized controlled clinical study evaluating one- and two-level TLIF procedures. 493 patients were randomized 1:1:1 into three groups: Infuse Bone Graft 2.1 mg/level, Infuse Bone Graft 4.2 mg/level, and Local Bone Autograft.

A 2025 FDA-approved protocol amendment incorporated a Bayesian adaptive design. Following the first interim analysis at 480 treated patients, the Independent Data Monitoring Committee determined that the primary endpoints were met for both Infuse dose groups and recommended stopping further enrollment. Patient follow-up continues to support comprehensive long-term data.

In the study, Infuse achieved fusion rates exceeding 90 percent in single-level TLIF and demonstrated comparably strong results in two-level constructs. Patients also showed earlier radiographic evidence of radiographic fusion compared to autograft, which may help reduce hardware stress and postoperative complications.

TLIF is one of the most commonly performed lumbar fusion procedures for patients with degenerative disc disease, disc herniation, or spinal instability. With this approval, Infuse Bone Graft can now be used as an option in indicated TLIF procedures, including with titanium or PEEK cages—static or expandable—and in 2-level constructs. The approval also supports use in patients with up to Grade 2 spondylolisthesis or Grade 2 retrolisthesis and offers multiple dose options to match graft volume to case demands. Infuse's radiolucent profile improves postoperative imaging, and its handling characteristics support consistent, efficient placement in the operating room.

In February 2017, Medtronic agreed to settle nearly all of thousands of lawsuits related to Infuse. The suits claimed the company promoted off-label uses of Infuse that resulted in personal injury.