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The NIDO™ Pedicle Screw System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, and/or lordosis), spinal tumor, pseudarthrosis and failed previous fusion.

The NIDO™ Pedicle Screw System is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. It is also intended for the following indications: trauma (i.e. fracture or dislocation); spinal stenosis; deformities or curvatures (i.e. scoliosis, and/or lordosis), tumor; pseudoarthrosis; and failed previous fusion.

The NIDO™ Pedicle Screw System Cannulated/Fenestrated Screws are intended to be used with saline and radiopaque dye.

The NIDO™ Pedicle Screw System is a modular head, multiple component posterior spinal fixation system which consists of subject modular pedicle screw tulips, and rod connectors manufactured from Titanium alloy Ti-6Al-4V per ASTM F136.

The subject pedicle screws are available in solid and cannulated/fenestrated configurations in various sizes to match patient anatomy. The fenestrated/cannulated screws are cannulated for use over a guidewire; they are fenestrated to allow the surgeon to apply a radiopaque dye or saline solution. The fenestrated/cannulated screws are not intended to allow for the use of bone cement. Screw tulips are available in standard, extended tab and closed styles, with a universal locking cap to lock the construct. Rod connectors are provided in domino, lateral and tulip styles.

The subject components are intended for use with previously cleared rods and crosslinks connectors from the primary predicate Cosmolock Pedicle Screw System.

This document is a 510(k) premarket notification decision letter from the FDA regarding a medical device, the NIDO™ Pedicle Screw System. It determines the device is substantially equivalent to legally marketed predicate devices.

Crucially, this document states: "No clinical studies were necessary to demonstrate substantial equivalence."

This means that the information requested regarding acceptance criteria, device performance from a clinical study, sample sizes for test sets, expert consensus, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for test/training sets cannot be provided from this document.

The device's substantial equivalence was determined based on non-clinical testing (mechanical tests) and comparison of technological characteristics (material, design, manufacturing process, indications for use) to predicate devices. Therefore, the requested clinical performance data and study details are not present.

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