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PATRIOT® TransContinental™ Spacers are interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with deqeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).

The PATRIOT® TransContinental® Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the PROTEX® or REVERE® Stabilization System.

The PATRIOT® TransContinental® Spacers are lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The spacers are inserted using an anterior or lateral approach to the lumbar spine. The devices are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. These spacers are to be filled with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion.

PATRIOT® Spacers are made from radiolucent polymer, with titanium alloy or tantalum markers, as specified in F2026, F136, F1295, and F560.

This document is a 510(k) premarket notification for the PATRIOT® TransContinental® Spacer, an intervertebral body fusion device. It describes the device and its intended use, but it does NOT contain a study or data proving the device meets acceptance criteria.

The 510(k) process is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. It does not typically require new clinical studies with acceptance criteria in the same way a PMA (Premarket Approval) submission would.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them because this document does not contain that information. It primarily focuses on demonstrating substantial equivalence to predicate devices, which is a different regulatory pathway.

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