FDA clears Wenzel Spine's primaLOK for expanded indications

August 22, 2023 By Sean Whooley

Austin, Texas-based Wenzel Spine designed primaLOK SP to provide surgeons with an effective and reliable solution for spinal stabilization. It’s now commercially available in the U.S.

The system combines cutting-edge engineering with a patient-focused design, Wenzel Spine says. Its design aims to provide a comprehensive solution for spinal fusion procedures, according to the company. New clinical indications with FDA clearance allow for the use of primaLOK SP at multiple levels in treating lumbar spinal stenosis.

“We are proud to receive FDA clearance to update the clinical indications for primaLOK SP,” Wenzel Spine CEO William E. Wilson said. “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.”

Features of primaLOK SP include a unique locking mechanism that ensures secure stabilization. This reduces the risk of migration and providing stability during the critical fusion process. It also enables precision and versatility with a high degree of flexibility. The system accommodates various patient anatomies and offers surgeons the ability to tailor each procedure to individual needs.

Wenzel Spine said the minimally invasive approach minimizes tissue disruption. That potentially leads to reduced post-operative pain, shorter hospital stays and quicker patient recovery. Its enhanced radiographic visibility also allows surgeons to confidently assess implant placement and fusion progress.

Texas-based neurosurgeon Dr. Charles Gordon called the system a “significant advancement for spinal fusion procedures.” Gordon founded Texas Spine & Joint Hospital in Tyler, Texas.

“Its versatile locking mechanism and patient-centric design truly set it apart,” Gordon said. “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.”

Filed Under: 510(k), Food & Drug Administration (FDA), Implants, Orthopedics, Regulatory/Compliance, Spine Tagged With: FDA, Wenzel Spine