SPINAL SIMPLICITY CLAIMS FIRST FDA CLEARANCE USING PERCUTANEOUS LATERAL APPROACH (Orthopedics This Week)
Overland Park, Kansas-based Spinal Simplicity, LLC, claims it has the only ISP (interspinous process) fusion device utilizing a percutaneous lateral approach to the spine cleared by the FDA for U.S. patients.
On January 9, 2015, the company announced the 510(k) FDA clearance of its Minuteman lateral percutaneous interlaminar fusion device.
The Minuteman
The device, according to the company, is a “pre-packaged sterile supplemental posterior fixation system” which offers a “minimally invasive alternative to traditional pedicle screws and other spinous process plates” placed in open procedures for the treatment of degenerative disc disease, spondylolisthesis, tumors and/or trauma. The system can be placed in patients utilizing two minimally invasive approaches to the spine, posterior unilateral or “lateral percutaneous (PercLIF-Percutaneous Lateral Interlaminar Fusion).”
While the company used several ISP fusion devices as predicate devices to gain FDA 510(k) clearance, Carlos Gonzalez, the company’s director of sales and marketing, told OTW that Lanx’s (Biomet, Inc.) Aspen device ...
