Wenzel Spine has gained US Food and Drug Administration (FDA) clearance for its primaLOK SP system—marking a “significant advancement in spinal fusion technology”, offering surgeons and patients a highly effective and reliable solution for spinal stabilisation, according to the company.
The primaLOK SP system combines cutting-edge engineering with patient-focused design to provide a comprehensive solution for spinal fusion procedures, Wenzel Spine also claims. The new clinical indications from this latest FDA clearance allow for the primaLOK SP to be used at multiple levels and to treat patients with lumbar spinal stenosis.
“The primaLOK SP system is a significant advancement for spinal fusion procedures,” said Charles Gordon (Texas Spine & Joint Hospital, Tyler, USA). “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.”
As per a Wenzel Spine press release, key features and benefits of the primaLOK SP system—which is now commercially available in the USA—include:
- Innovative locking mechanism: The primaLOK SP system boasts a unique locking mechanism that ensures secure stabilisation, reducing the risk of migration and providing stability during the critical fusion process
- Precision and versatility: Engineered with precision, the unique polyaxial primaLOK SP system offers a high degree of flexibility to accommodate various patient anatomies and offers surgeons the ability to tailor each procedure to individual needs
- Minimised tissue disruption: The system’s minimally invasive approach minimises tissue disruption, potentially leading to reduced postoperative pain, shorter hospital stays, and quicker patient recovery
- Enhanced radiographic visibility: The device design prioritises enhanced radiographic visibility, allowing surgeons to confidently assess implant placement and fusion progress
“We are proud to receive FDA clearance to update the clinical indications for primaLOK SP,” said Wenzel Spine CEO William E Wilson. “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.”
