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...