Transforaminal lumbar interbody fusion, or TLIF, has become one of the most commonly performed lumbar fusion procedures today.1 Minimally invasive techniques, advanced implants, navigation, and biologics have reshaped how these procedures are performed and how patients recover.
For all the technology surrounding the procedure, its long-term success still comes down to a basic goal: fusion of the vertebrae. That puts bone fusion at the center of the equation and makes the evidence behind the technologies used to support fusion especially important.
An Established Technology Moves into TLIF
Infuse™ bone graft† from Medtronic uses recombinant human bone morphogenetic protein-2 (rhBMP-2) to stimulate the body’s natural bone-forming process.2 Unlike traditional bone grafts that primarily provide a scaffold for new bone to grow, rhBMP-2 actively signals cells involved in bone formation, helping drive the biologic process of fusion. It’s the only approved growth factor with a proven mechanism of action that induces new bone growth — without harvesting autograft.3
Infuse™ bone graft has been used clinically for more than two decades, including in FDA-approved anterior or oblique lumbar fusion procedures. For TLIF procedures, the Infuse™ graft received Breakthrough Device Designation in 2024 and premarket approval for one- and two-level procedures from L2-S1 in February 2026.4
The TLIF indication includes use with indicated PEEK or titanium cages, including static and expandable designs, as well as in one- or two-level procedures.5 Infuse™ is the only bone graft with level 1 data showing superior fusion success compared to autograft in challenging two-level fusion procedures.‡
The Evidence Behind the Approval
The Infuse™ bone graft FDA approval was supported by a randomized clinical study of 493 patients undergoing one- or two-level TLIF.6 The results met the study’s predefined criteria for success at an early analysis, prompting an independent monitoring committee to recommend ending enrollment early.7
In the study, patients receiving Infuse™ bone graft showed earlier radiographic evidence of fusion compared with the control group, with fusion rates reaching up to 90% at 24 months in single-level TLIF and up to 87% at 24 months in two-level procedures.5 Long-term follow-up of patients continues.
Beyond the Clinical Outcome
For hospitals, selecting a bone graft isn’t solely a clinical decision.
The value of Infuse™ bone graft was demonstrated recently when it received Medicare New Technology Add-on Payment (NTAP) status for TLIF procedures, effective October 1, 2026.8 NTAP provides additional Medicare payment for eligible new technologies used in inpatient hospital care, helping offset some of the costs associated with their adoption.
The Next Chapter of Lumbar Fusion
TLIF continues to evolve as minimally invasive techniques and advances in implants, navigation, and biologics aim to improve efficiency and consistency. Bringing those elements together while maintaining the focus on successful fusion can benefit both patients and care teams.
The Infuse™ bone graft TLIF approval is one example of that evolution: taking an established technology, rigorously studying it in a new setting, and building the evidence to support broader use.
In a rapidly moving field, innovation isn’t just about what comes next. It’s also about proving what works.
Footnotes
†DO NOT USE IF PREGNANT/NURSING. AVOID PREGNANCY FOR ONE YEAR. See the ISW for boxed warning and risks.
‡Accurate and accessed September 9, 2026.
References
- Phani Kiran S, Sudhir G. J Clin Orthop Trauma. 2021;22:101592.
- FDA. Summary of Safety and Effectiveness Data (P000058).
- Burkus JK, Gornet MF, Schuler TC, Kleeman TJ, Zdeblick TA. J Bone Joint Surg Am. 2009;91(5):1181-1189.
- Medtronic. FDA approval of Infuse™ bone graft for TLIF procedures. 2026.
- FDA. Summary of Safety and Effectiveness Data (P000058/S096).
- ClinicalTrials.gov. NCT04073563. Updated 2026.
- Medtronic. FDA approval of Infuse™ bone graft for one- and two-level TLIF procedures. 2026.
- Medtronic. INFUSE Bone Graft for TLIF Receives Eligibility for Medicare New Technology Add-on Payment, Advancing Reimbursement Support for Hospitals and Spine Surgeons. 2026.
