PARAMOUNT INTERVERTEBRAL BODY FUSION DEVICE

K072120MAX10/11/2007

Applicant

INNOVATIVE SPINAL TECHNOLOGIES INC

Intended Use

The Paramount™™ IBF device, when used with autogenous bone graft, is indicated for use 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 level(s). 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.

Indications for Use

The Paramount™™ IBF device, when used with autogenous bone graft, is indicated for use 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 level(s). 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.

Predicate Devices

  • K062759 - Paramount™™ VBR System (MAX)
  • P950002 - BAK™™ Interbody Fusion System (MAX)