IMPIX 3D Print Cages

K163595MAX11/13/2017

Applicant

MEDICREA INTERNATIONAL S.A.

Intended Use

To provide immobilization and stabilization of anterior spinal segments, to augment the development of a solid spinal fusion, to provide stability to ease fusion, to be mechanically resistant to allow the fusion of the operated level

Indications for Use

IMPIX 3D Print cages are indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft. IMPIX 3D Print cages are to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

Predicate Devices

  • K150481 - K2M Cascadia Interbody System (MAX)
  • K072226 - MEDICREA INTERNATIONAL IMPIX-L (MAX)
  • K121760 - CAPSTONE® Spinal System (MAX)
  • 083798 - MEDICREA IMPIX ALIF (MAX)
  • K151214 - NUVASIVE INTERFIXED SYSTEM (MAX)