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Wenzel Spine Granted FDA Clearance to Expand Clinical Indications for the primaLOK SP Solution

Wednesday, August 23, 2023

Wenzel Spine, a pioneering medical technology firm dedicated to developing minimally invasive surgical solutions and diagnostic platforms for spinal disorder treatments, is thrilled to announce the recent FDA clearance for their revolutionary primaLOK SP System. This achievement stands as a notable leap forward in spinal fusion technology, presenting both patients and surgeons with a dependable and highly effective means of spinal stabilization. By seamlessly integrating cutting-edge engineering with patient-centric design, the primaLOK SP System offers a holistic approach to spinal fusion procedures.

This clearance is a testament to Wenzel Spine's steadfast commitment to delivering top-quality products that enhance surgical outcomes and elevate the well-being of patients. The expanded clinical indications granted by the FDA enable the primaLOK SP to be utilized across various levels, extending treatment possibilities to those suffering from lumbar spinal stenosis.

Key Attributes of the primaLOK SP System encompass:

  • Innovative Locking Mechanism: Distinguished by its inventive locking mechanism, the primaLOK SP System guarantees secure stabilization, effectively minimizing migration risks and ensuring stability during the critical fusion process.
  • Precision and Adaptability: Engineered with precision, the polyaxial primaLOK SP System offers exceptional flexibility, accommodating diverse patient anatomies. This empowers surgeons to tailor each procedure to the individual needs of their patients.
  • Minimal Tissue Disruption: Embracing a minimally invasive approach, the system significantly reduces tissue disruption. This potential reduction in postoperative discomfort may lead to shorter hospital stays and speedier patient recovery.
  • Enhanced Radiographic Visibility: The device's design prioritizes improved radiographic visibility, empowering surgeons to confidently assess implant placement and track fusion progress.

The primaLOK SP System represents a substantial stride in spinal fusion procedures, attributed to its adaptable locking mechanism and patient-oriented design. Wenzel Spine's achievement in obtaining FDA clearance underscores their unwavering dedication to propelling spinal healthcare forward and revolutionizing the realm of spinal fusion surgeries.



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