Approved Products in the USA: AxiaLIF

Abstract

Axial lumbar interbody fusion (AxiaLIF) was a device used to treat instability and disc degeneration in L4-L5 and L5-S1. Through a paracoccygeal incision and presacral approach, muscular and ligamentous dissection could be avoided. The discectomy and instrumentation was performed through via trans-sacral rod. AxiaLIF was approved in 2004 through a 510 (k) clearance from a predicate device which was an anterior thoracolumbar plate for trauma and deemed a class 2 device with a moderate risk to the patient. While early studies had encouraging results in terms of fusion rates and improvement in clinical outcome measures, most also had a conflict of interest. As the technology was rapidly adopted, the first reports of complications which were visceral injuries emerged casting doubt onto its effectiveness. Only a handful of studies focused on the long-term fusion rate, restoration of lordosis, and indirect decompression. In retrospect, it is apparent that the 510 (k) clearance and classification of the device was incorrect because the predicate was not substantially equivalent to the existing device. The experience with AxiaLIF provides a cautionary tale about new technology – that it should be safe, clinically effective, and have long-term data prior to rapid adoption.