iFuse Implant SystemTM Solution

SI-BONE, Inc. has developed an innovative, patented, intramedullary implant system to treat Sacroiliac (SI) Joint dysfunction. The iFuse Implant SystemTM consists of Fusion Implants and associated surgical instruments.
iFuse Implants

The detailed surgical technique description includes the implantation of 7.0mm or 4.0mm triangular Fusion Implants with arc plasma spray surface to increase the interference fit of the implant.

Most patients receive three fusion implants, although four have been used in larger patients. Available implant lengths range from 30mm to 55mm in 5mm increments. These implants are delivered to the Sacroiliac (SI) Joint using a cannulated delivery system and soft tissue protection instruments.

The SI-BONE iFuse Implant SystemTM is indicated for fracture fixation of large bones and large bone fragments of the pelvis for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

Key benefits of the iFuse Implant SystemTM include:

  • Less invasive surgery with no extensive soft tissue stripping
  • Simple surgical approach
  • Triangular profile minimizes rotation and micromotion
  • Rigid titanium rods provide immediate post-op Sacroiliac (SI) Joint stability
  • Porous plasma spray coating with irregular surface supports stable bone fixation/fusion
  • Large surface area promotes accelerated time to weight bearing
  • Biomechanically superior to conventional surgical fixation

Surgical Technique

Locate area for incision Make ~ 3 cm incision
Insert Steinmann Pin Determine length of
iFuse Implant
Drill Broach
Insert iFuse Implant Repeat, as needed, for
additional iFuse Implants
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SI-BONETM and iFuse Implant SystemTM are trademarks of SI-BONE, Inc.
An Advanced Approach to Surgical Management of SI Joint Dysfunction
Up to 25% of all low back pain is SI Joint in origin – but the diagnosis of SI Joint disease is frequently overlooked. (Cohen, et al.)
It is common to link low back pain with protruding disc even when neurological signs are absent. (Weksler, et al.)
It is common for pain from SI Joint dysfunction to mimic discogenic or radicular low back pain. (Weksler, et al.)
Many patients go on to receive lumbar fusion instead of SI Joint fusion – so SI Joint disease should be strongly considered in differential diagnosis of low back pain. (Weksler, et al.)
Now there is an approach to surgical management of SI Joint dysfunction that’s easier and less invasive than traditional open surgery.
The iFuse Implant System consists of porous plasma spray coated implants, surgically inserted across the SI Joint to create fixation leading to fusion—from the inside.
The iFuse creates a biomechanically rigorous fixation/fusion system, designed to support reliable fixation/fusion and acute weight bearing capacity.
With the iFuse Implant System, there is no need for BMP in conjunction with autologous bone graft or additional pedicle screws, rods or hollow modular anchorage screws or cannulated compression screws or threaded cages within the joint or fracture fixation screws.
iFuse benefits:
The iFuse Implant System is designed to be the sacroiliac joint fusion/fixation method of choice for spine surgeons.
iFuse is a minimally invasive surgical solution to replace open surgical SI Joint fusion.
With iFuse there's minimal incision size, minimal soft tissue stripping, minimal tendon irritation and reduced risk of infection.
iFuse is a simplified minimally invasive surgical procedure.
Just drill, broach, insert Implants and close.
iFuse has a simple technique which reduces OR time to less than 1 hour.
iFuse has 3X shear and 7X bending strength compared with screws.
iFuse has improved patient perception of stability post-implant.
The incidence of SI joint degeneration in patients was 75% at 5 years post-fusion, which was significantly higher than in the non-fusion group, 38.2%. (Ha, et al.)
Among patients with one-segment fusion, 91% developed SI joint degeneration. (Ha, et al.)
Regardless of whether the fusion includes the sacrum, the SI joint is influenced by increased mechanical stress arising from lumbar/lumbosacral fusion. (Ha, et al.)
Posterolateral lumbar/lumbosacral fusion can be a cause of SIJ degeneration. (Ha, et al.)