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FDA approval (expanded indication) · Medtronic · Orthopedics

Infuse Bone Graft for TLIF

rhBMP-2 bone graft is now approved for one- and two-level TLIF.

CompareMedtronic press release
Approved · PMA supplementBreakthrough device

Infuse Bone Graft for TLIF

Medtronic · Orthopedics

Type
Implant
FDA route
PMA supplement
Setting
Operating room
Used by
Spine surgeons and neurosurgeons
Bottom line for your practice
55s read

Surgeons can now use Infuse on label in one- and two-level TLIF procedures from L2-S1, with titanium or PEEK cages and multiple dose options. The release reports fusion results but no safety data.

What it is
A growth factor bone graft used to support spinal fusion, now approved for transforaminal lumbar interbody fusion (TLIF) with PEEK or titanium interbody cages.
Indicated for
Patients undergoing TLIF at one or two levels from L2-S1 with PEEK or titanium interbody cages, including patients with up to Grade 2 spondylolisthesis or Grade 2 retrolisthesis.
What changes
The study compared two Infuse doses against local bone autograft. Medtronic says patients showed earlier radiographic evidence of fusion than with autograft.
Evidence
Head-to-head randomized trialINFUSE TLIF Study · n=493493 patients were randomized 1:1:1 to Infuse 2.1 mg/level, Infuse 4.2 mg/level or local bone autograft; at the first interim analysis at 480 treated patients, the Independent Data Monitoring Committee determined the primary endpoints were met for both Infuse dose groups and recommended stopping further enrollment. Infuse achieved fusion rates exceeding 90 percent in single-level TLIF.Randomized against an active treatment: the most direct evidence on how it compares with an existing option.
Watch for
The release gives no adverse event data, contraindications or warnings, and no numeric fusion rate for two-level constructs or for the autograft group. The data monitoring committee recommended stopping enrollment after the first interim analysis, and patient follow-up is continuing.
FDA decision
  1. 510(k)Cleared
  2. De NovoGranted
  3. PMAApproved
PMA supplement. A change to a Class III device that already has premarket approval, here a new indication. The FDA reviewed the evidence for the change, not the whole device again; depending on the change, that may or may not include new clinical data.Breakthrough Device designation: for devices that may offer more effective treatment or diagnosis of a life-threatening or irreversibly debilitating condition. It speeds the FDA's interaction and review. It does not lower the standard for authorization.

Clinical summary

The approval extends Infuse (recombinant human bone morphogenetic protein-2) to transforaminal lumbar interbody fusion at one or two levels from L2 to S1, with PEEK or titanium cages, in patients with up to grade 2 spondylolisthesis. A randomized trial of 493 patients comparing two rhBMP-2 doses with local autograft stopped enrollment early after meeting its primary endpoints. Medtronic reports fusion rates above 90% for single-level TLIF.

From the source 14

Medtronic press release

The Medtronic press release's own words, quoted exactly. Each line is what a claim on this page was checked against.

  1. February 17, 2026 — Medtronic, a global leader in healthcare technology, today announced U.S. Food and Drug Administration (FDA) Premarket Approval (PMA) 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.

    Backs · PMA for TLIF at one or two levels from L2-S1 (new indication, recorded as PMA supplement)

  2. This approval expands the versatility of INFUSE™, making it the only PMA-approved growth factor bone graft for ALIF, OLIF, and now TLIF—and the only growth factor bone graft product approved for spine fusion, including 2-level constructs for TLIF.

    Backs · New indication for an already approved device

  3. 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.

    Backs · Breakthrough Device Designation

View all 14 lines

  1. Medtronic submitted a panel-track PMA application on August 18, 2025.

    Backs · Panel-track PMA application

  2. The PMA approval is supported by a prospective, multicenter, randomized controlled clinical study evaluating one- and two-level TLIF procedures.

    Backs · Randomized controlled study

  3. 493 patients were randomized 1:1:1 into three groups:

    Backs · 493 patients randomized 1:1:1

  4. INFUSE™ Bone Graft 2.1 mg/level

    Backs · Dose 2.1 mg/level

  5. INFUSE™ Bone Graft 4.2 mg/level

    Backs · Dose 4.2 mg/level

  6. 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.

    Backs · Interim analysis at 480 treated patients

  7. In the study, INFUSE™ achieved fusion rates exceeding 90 percent in single-level TLIF and demonstrated comparably strong results in two-level constructs.

    Backs · Fusion rates exceeding 90 percent

  8. Patients also showed earlier radiographic evidence of radiographic fusion compared to autograft, which may help reduce hardware stress and postoperative complications.

    Backs · Earlier fusion versus autograft

  9. 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.

    Backs · Grade 2 spondylolisthesis or retrolisthesis

  10. Patient follow-up continues to support comprehensive long-term data.

    Backs · Follow-up continues

  11. Global Investigator for the INFUSE™ TLIF Study.

    Backs · Study name

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