ALIF Interfixated System

K151214OVD6/25/2015

Applicant

NuVasive, Incorporated

Intended Use

The ALIF Interfixated System is intended for spinal fusion procedures with autograft. The 10° - 20° lordotic cages may be used as a standalone system, while the 25° - 30° lordotic cages must be used with supplemental internal spinal fixation systems.

Indications for Use

The ALIF Interfixated System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2 to S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved level(s). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the system.

Predicate Devices

  • K123045 - NuVasive Brigade™ Hyperlordotic System (OVD)
  • K100043 - NuVasive CoRoent™ XLR Standalone System (OVD)
  • K120918 - NuVasive CoRoent™ Titanium System (OVD)
  • K071795 - NuVasive CoRoent™ System (OVD)
  • K073109 - Surgicraft™ Limited STALIF® TT Intervertebral Body Fusion System (OVD)
  • K141942 - Centinel Spine™ Midline I™ / Midline I-Ti™ (OVD)