Wenzel Spine’s primaLOK SP OK’ed for Multiple Fusion Levels

Wenzel Spine has earned U.S. Food and Drug Administration (FDA) clearance for an expanded indication of its primaLOK SP system for spinal fusion procedures, allowing it to be used at multiple levels and to treat spinal stenosis.
 
The company said primaLOK SP features a locking mechanism that helps with secure spinal stabilization, reducing migration and offering stability during fusion. Its polyaxial design can accommodate various anatomies and each procedure using primaLOK SP can be tailored to individual needs.
 
“We are proud to receive FDA clearance to update the clinical indications for primaLOK SP. This achievement reflects our ongoing commitment to innovation and excellence in our spinal solutions. We believe this system will significantly contribute to improved patient outcomes through a less invasive approach,” William E. Wilson, CEO of Wenzel Spine told the press.
 
A minimally invasive surgical approach minimizes tissue disruption, which might lead to less post-op pain, shorter hospital stays, and quicker recovery. primaLOK’s design also prioritizes better radiographic visibility to help assess implant placement and fusion progress.
 
Dr. Charles Gordon, MD, a renowned neurosurgeon and founder of Texas Spine & Joint Hospital, told the press, “The primaLOK SP System is a significant advancement for spinal fusion procedures. Its versatile locking mechanism and patient-centric design truly set it apart. These expanded clinical indications will allow me to further incorporate this system into my practice and provide my patients with a higher level of care.”
 
primaLOK is now commercially available in the U.S.