Nevro1* Sacroiliac Transfixing and Fusion System:
Nevro1™ Sacroiliac (SI) Transfixing and Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
Contraindications may be relative or absolute. Nevro1SI Transfixing and Fusion System components are contraindicated in the following patient situations:
- Deformities.
- Tumor resection.
- Infection local to the operative site and/or signs of local inflammation.
- Failed previous fusion.
- Suspected or documented allergy or intolerance to the component materials.
- Any condition not described in the indications for use.
There are potential risks identified with the use of Nevro1 SI Transfixing and Fusion System. For information about risks, please refer to the Nevro1 Instructions for Use.
SICONUS SI Joint Fixation System:
The SICONUS™ SI Joint Fixation System is intended to provide fixation and stabilization of large bones, including the sacrum and ilium. It is intended for use in skeletally mature patients as an adjunct to sacroiliac joint fusion in the treatment of degenerative sacroiliitis, or sacroiliac joint disruptions.
Contraindications may be relative or absolute. SICONUS™ SI Joint Fixation System components are contraindicated in the following patient situations:
- When there is active systemic infection, infection localized to the site of the proposed implantation, or when the patient has demonstrated an allergy or foreign body sensitivity to any of the implant material.
- Severe osteoporosis may prevent adequate fixation and thus preclude the use of this or any other orthopedic implant.
- Conditions that may place excessive stresses on the bone and implants, such as severe obesity or degenerative diseases, are relative contraindications. The decision whether to use these devices in such conditions must be made by the physician taking into account the risks versus the benefits to the patients.
- Use of these implants is relatively contraindicated in patients whose activity, mental capacity, mental illness, alcoholism, drug abuse, occupation, or lifestyle may interfere with their ability to follow postoperative restrictions and who may place undue stresses on the implant during bone healing and may be at a higher risk for implant failure.
There are potential risks identified with the use of SICONUS SI Joint Fixation System. For information about risks, please refer to the SICONUS SI Joint Fixation System Instructions for Use.
VYRSA Pro:
The VYRSA™ Pro SI Fusion Spacer is intended for fracture fixation of large bones and large bone fragments of the pelvis for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. The Nevro Pro SI Fusion Spacer is to be used with autologous bone graft and implanted via an open or and minimally invasive posterior approach.
There are potential risks identified with the use of VYRSA Pro SI Fusion Spacer. For information about risks, please refer to the Nevro Pro manuals.
*Nevro has acquired VYRSA Technologies. For the purposes of marketing materials, the VYRSA products will be referenced as Nevro products. SICONUS™ SI Joint Fixation System or Lateral Screws or VYRSA™ Fix will be referenced** as NevroFix™ and VYRSA™ Pro SI Fusion System will be referenced** as NevroPro™.
**Pending regulatory registration