Technical Assessment of Nu-Fix
December 2009
This Technical Assessment was prepared by the AANS Emerging Technology Committee using systematic review methodology, and summarizes the findings of studies published and other publicly available information as of December 2009 on Nu-Fix by Nutech Medical. As a summary, this document does not make recommendations for or against the use of Nu-Fix by Nutech Medical. It should not be construed as an official position of the American Association of Neurological Surgeons. Readers are encouraged to consider the information presented in this assessment and reach their own conclusions concerning the subject matter.
The American Association of Neurological Surgeons has developed and is providing this Technical Assessment as an educational tool. Patient care and treatment should always be based on a physician’s independent medical judgment given the individual patient’s clinical circumstances.
| Assessment Date |
Dec/2009 |
| Manufacturer |
Nutech Medical
Birmingham, AL
Currently certified as a Tissue Bank |
| Website |
http://nufix.org/ |
| Stated Purpose |
Minimally Invasive Spinal Facet Fusion |
| Cost of Device |
$5,000 per set to treat 1 level |
| FDA Approval |
Cortical Bone Screw 510(k), FDA approved as a bone graft to provide stability for primary and secondary healing of bone. |
| Usage History |
Introduced to US market in 2006. Company reports several thousand procedures covering all 50 states. |
| Current Providers |
Majority (60-70%) Pain Clinic Physicians, remainder divided between Ortho, PM&R, Neurosurgery. Company estimates that approximately 150 – 200 physicians have been trained. |
| Site of Service |
Ambulatory Surgery Center (>75%), some office, few inpatient. |
| Clinical Indications |
Facet arthrosis with spine pain |
| Diseases Treated |
Cervical, Thoracic and lumbar degenerative pain |
| Technique |
Allograft interference screw is percutaneuosly or through stab incision, inserted into the facet joint (cervical, thoracic, or lumbar) to stiffen the joint and promote fusion. |
| Supporting Literature |
No current publications in US literature. Two vendor sponsored unpublished articles are attached. |
| Vendor Suggested Coding |
Vendor suggests the use of 22600, 22610 or 22612 (posterior fusion cervical, thoracic or lumbar).
Currently a Cat III tracking Code has been approved by CPT and id soon to be released |
| Assessment |
FDA approved as a threaded bone dowel for minimally invasive facet fusion. Marketing has been primarily aimed at non-surgeons in out patient pain clinic settings. There is no published data to assess safety, efficacy, or outcomes. There is no relevant biomechanical data available to use as a comparison to currently performed spinal fusion procedures. Manufacturer sponsored literature is very limited in number, scope and follow-up. In conclusion there is insufficient objective information to evaluate the safety and utility of this device or to make recommendations regarding clinical usage. |
| **The manufacturer has been contacted requesting any possible scientific data not identified in a literature search. |