CRESCENT™ Spinal System

K171031MAX7/6/2017

Applicant

Medtronic Sofamor Danek

Intended Use

interbody fusion with autogenous bone graft in patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. 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 six months of non-operative treatment. These devices are intended to be used with supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine.

Indications for Use

The CRESCENT™ Spinal System is indicated for interbody fusion with autogenous bone graft in patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. 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 six months of non-operative treatment. These devices are intended to be used with supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine.

Predicate Devices

  • K094025 - CRESCENT™ Spinal System (MAX)
  • K110543 - CRESCENT™ Spinal System Titanium (MAX)
  • K132897 - Clydesdale Spinal System (MAX)
  • K132053 - Rampart-O, Rampart-T (MAX)