iFuse 3D™ Implant System

iFuse 3D™ Implant System

SI-BONE

iFuse 3D™ Implant System

  • The only clinically proven sacroiliac (SI) joint fusion system.
  • Over 100 publications – 2 RCT.
  • Over 100,000 cases performed worldwide.
  • Minimally invasive SI joint fusion is a surgical solution for SI joint pain when non-surgical methods have failed to provide sustained relief. The iFuse Implant System®, available since 2009, is a minimally invasive surgical (MIS) option designed to provide immediate SI joint stabilisation and allow long-term fusion.
  • SI-BONE offers a wide range of training options.

Sacropelvic Solutions

  • SI joint dysfunction: Clinically proven.
  • Pelvic trauma: Fix. Fuse. Fortify.
  • Spinopelvic fixation: Fixation. Fusion. Foundation
  • Minimally invasive surgery
  • Patented triangular design
  • 3D printed
  • Self-harvesting technology1
  • Six times greater rotational resistance vs. a 12mm screw2
  • Demonstrated clinical outcomes3-7
    • Rapid pain relief
    • Improvement of back function
    • High patient satisfaction
    • Superior outcome to non-surgical management3-4
  • Low revision rate3-7
  • Long-term five year results8
    • Minimally invasive lateral transiliac sacroiliac joint fusion
    • Multicentre prospective trial
    • 103 Patients/12 Sites
    • 3D printed trabecular surface mimics native cancellous bone and enhances osteointegration1
  • 95% Patient satisfaction
  • 88% Bridging bone within the SI joint
  • 36% Decrease in opioid use
  • 54 Pt VAS improvement
  • 26 Pt ODI improvement
  1. MacBarb R, Lindsey D, Woods S, et al. Int J Spine Surg 2017;11:116–28.
  2. SI-BONE 300610-TS. Torsional Rigidity of the iFuse Implant Compared with a SI Joint.Screw in a Sawbones Model. March 12, 2018.
  3. Polly DW, Swofford J, Whang PG, et al. Int J Spine Surg 2016;10:Article 28.
  4. Dengler J, Kools D, Pflugmacher R, et al. J Bone Joint Surg Am 2019;101:400–11.
  5. Whang PG, Darr E, Meyer SC, et al. Med Devices (Auckl) 2019;12:411-422 [Epub 2019 Sep 26].
  6. Duhon BS, Bitan F, Lockstadt H, et al. Int J Spine Surg 2016;10:Article 13.
  7. Patel V, Kovalsky D, Meyer SC, et al. Med Devices (Auckl). 2021;Volume 14:211–6.
  8. Whang PG, Darr E, Meyer SC, et al. Med Devices (Auckl) 2019;12:411-422 [Epub 2019 Sep 26].

SI-BONE internal:

Source: 11232.062623 (EN) EMEA Combined Brochure

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