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SI-Cure Implant

The SI-Cure Implant was conceived and designed to optimize the treatment of patients with SI joint pain by providing compression, fixation and fusion. We have more than 5-years of clinical experience using a straightforward and clinically proven lateral technique. By focusing on fusion, the SI-Cure Implant offers patients the potential for great outcomes.

  • Patented design provides graft contact along the length of the implant
  • Features a Self-HarvestingTM design that collects autograft as the Implant is advanced, thus eliminating the need for bone graft.
  • As the Implant is advanced, the helical design pushes the bone into the open architecture of the implant allowing the Self-AdvancingTM autograft to backfill the length of the Implant.
Intraoperative flouro image demonstrating SI-Cure Implant self-harvesting fenestrations 
Intraoperative flouro image demonstrating SI-Cure Implant placement
3-month postoperative CT image demonstrating bony ingrowth

SEE HOW SI-CURE WORKS

SI-Cure Sacroiliac Joint Fusion System

The SI-Cure Sacroiliac Joint Fusion System consists of Implants and a set of surgical instruments. The SI-Cure implants are cannulated, and fully threaded with double helix threads designed to be inserted into pre-drilled bone. The Implants are fabricated from medical grade titanium alloy, Ti-6Al-4V (ASTM F-136) and have a textured surface that encourages bony on-growth. The SI-Cure Implants come in various sizes to accommodate varying patient anatomy. Optional pivoting washers are included for each screw diameter to aid in conforming to patient anatomy.

Implant Specifications

  • 9.5mm and 11mm Diameters
  • Optional Load Distribution Cap
  • Lengths 35-90mm

9.5mm Diameter Implants

9 .5mm x 35mm, 900.095.35
9 .5mm x 40mm, 900.095.40
9 .5mm x 45mm, 900.095.45
9 .5mm x 50mm, 900.095.50
9 .5mm x 55mm, 900.095.55
9 .5mm x 60mm, 900.095.60
9.5mm x 65mm, 900.095.65
9.5mm x 70mm, 900.095.70
9.5mm x 75mm, 900.095.75
9.5mm x 80mm, 900.095.80
9.5mm x 85mm, 900.095.85
9.5mm x 90mm, 900.095.90

9.5mm LOAD DISTRIBUTION CAP

9 .5mm, 900.095

11mm Diameter Implants

11mm x 35mm, 900.11.35
11mm x 40mm, 900.11.40
11mm x 45mm, 900.11.45
11mm x 50mm, 900.11.50
11mm x 55mm, 900.11.55
11mm x 60mm, 900.11.60
11mm x 65mm, 900.11.65
11mm x 70mm, 900.11.70
11mm x 75mm, 900.11.75
11mm x 80mm, 900.11.80
11mm x 85mm, 900.11.85
11mm x 90mm, 900.11.90

11mm LOAD DISTRIBUTION CAP

11mm, 900.11

Surgical Instrument System

The SI-Cure Surgical Instrument System is comprised of various surgical instruments used to prepare the site to insert the implants.

All instruments are made in the United States from surgical grade materials.

Indications for Use 

The SI-Cure Sacroiliac Joint Fusion System is intended for sacroiliac fusion for the following conditions:

  • Sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.
  • To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
  • Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.

Contraindications

Contraindications for use of the SI-Cure Sacroiliac Joint Fusion System include,
but are not limited to:

• Infection
• Tumor
• Severe osteoporosis
• Mental or physical impairments that limit a patient’s ability to comply with necessary limitation of postoperative instructions.

Refer to the SI-Cure Sacroiliac Joint Fusion System package insert document (FRM-002.4) for complete safety information including:

• Warnings and Precautions
• Potential Adverse Events
• Care and Handling of Instruments
• Sterilization and Packaging

Resources

SI-Cure Sacroiliac Joint Fusion System Package Insert, FRM-002.4 Rev C

International Society for the Advancement of Spine Surgery Policy 2020 Update—Minimally Invasive Surgical Sacroiliac Joint Fusion (for Chronic Sacroiliac Joint Pain): Coverage Indications, Limitations, and Medical Necessity