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The EUROPA™ Pedicle Screw System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.

The EUROPA™ Pedicle Screw System is intended for posterior, noncervical pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The EUROPA™ Pedicle Screw System is comprised of both Open and Minimally Invasive Surgery (MIS) polyaxial pedicle screw and rod components that are available in different sizes to accommodate various patient anatomical and physiological requirements. The pedicle screws are manufactured from Ti-6Al-4V ELI alloy (ASTM F136). The rods are manufactured from Molybdenum-47.5Rhenium alloy (ASTM F3273) or cobalt chromium alloy (ASTM F1537).

This document is a 510(k) summary for the EUROPA™ Pedicle Screw System, seeking market clearance for sterile-packaged rod components. It is a Class II medical device, and the submission is a "Special 510(k)" because it is nearly identical to previously cleared devices (K180337, K182970), with the only change being the terminal sterilization method for the rod components.

Therefore, the document does not provide information about acceptance criteria or a study proving the device meets those criteria for the following reasons:

• No new performance data is presented or required. The submission explicitly states under "IX. PERFORMANCE DATA": "Performance data is not provided in this submission." This is because the device is largely identical to its predicate devices, and the change (sterilization method) is addressed through an "Adequate description of the sterilization method" rather than a clinical or performance study.
• This is a 510(k) summary. A 510(k) submission generally demonstrates substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive new performance studies as would be required for a PMA (Premarket Approval Application). A "Special 510(k)" limits the required information even further when the modifications do not affect the device's fundamental function, safety, or effectiveness.

Based on the provided text, I cannot extract the requested information regarding acceptance criteria and performance study details because the document explicitly states that no performance data is provided for this submission.

The document's purpose is to get clearance for a minor change (sterilization of a component) to an already cleared device, not to present novel performance data.

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