INTREPID SPINAL SYSTEM

K080083MAX4/10/2008

Applicant

MEDTRONIC SOFAMOR DANEK

Intended Use

The INTREPID™ Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1.

Indications for Use

The INTREPID™ Spinal System is indicated for use 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 implants may be implanted via a laparoscopic or an open anterior approach. The INTREPID™ interbody device is intended to be used with the three titanium alloy screws which accompany the implant. If the physician chooses to use less than three, or none of the provided screws, then additional supplemental fixation, which has been cleared by the FDA for use in the lumbar spine, must be used to augment stability.

Predicate Devices

  • K072253 - SynFIX-LR Spacer (MAX)
  • P970015 - LT-CAGE® Peek Lumbar Tapered Fusion Device (MAX)
  • P950002 - BAK® Cage (MAX)
  • P950019 - RAY® Threaded Fusion Cage (MAX)
  • P960025 - Lumbar I/F Cage (MAX)
  • K072120 - PARAMOUNT Intervertebral Body Fusion Device (MAX)