PATRIOT SPACERS

K072970MAX1/18/2008

Applicant

GLOBUS MEDICAL, INC.

Intended Use

PATRIOT™ Spacers (Constitution™™ PLIF, Continental™™ ALIF, TransContinental™™ LLIF and Signature™™ TLIF 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 degeneration 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).PATRIOT™™ 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.

Indications for Use

PATRIOT™ Spacers (Constitution™™ PLIF, Continental™™ ALIF, TransContinental™™ LLIF and Signature™™ TLIF 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 degeneration 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).

Predicate Devices

  • P95002 - BAK Interbody Fusion System (MAX)