STALIF TT INTERVERTEBRAL BODY FUSION SYSTEM

K073109OVD6/4/2008

Applicant

SURGICRAFT LTD.

Intended Use

The STALIF™ TT Intervertebral Body Fusion 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. Patients with previous non-fusion spinal surgery at the treated level may be treated. These implants may be implanted via a laparoscopic or an open anterior approach.

Indications for Use

The STALIF™ TT Intervertebral Body Fusion 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. Patients with previous non-fusion spinal surgery at the treated level may be treated. These implants may be implanted via a laparoscopic or an open anterior approach.

Predicate Devices

  • K080083 - Intrepid™ Spinal System Device, Medtronic Sofamor Danek, USA (OVD)
  • K051027, K041617 - STALIF™ TT Vertebral Body Replacement Device, Surgicraft Limited (OVD)
  • K072415 - STALIFT™ C Intervertebral Body Fusion Device, Surgicraft Limited (OVD)
  • P970015, S022 - LT-Cage Lumbar Tapered Fusion Device, Medtronic Sofamor Danek, USA (OVD)