IMPIX SPACER

K072226•MAX•12/10/2007

Applicant

MEDICREA TECHNOLOGIES

Intended Use

IMPIX-C Cervical Interbody Device is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level from C3-C7. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. This device is to be used with autogenous bone graft. IMPIX-C Cervical Interbody Device is to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage. IMPIX-L Lumbar Interbody Device is 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-L Lumbar Interbody Device is 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.

Indications for Use

IMPIX-C Cervical Interbody Device is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level from C3-C7. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. This device is to be used with autogenous bone graft. IMPIX-C Cervical Interbody Device is to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage. IMPIX-L Lumbar Interbody Device is 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-L Lumbar Interbody Device is 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

  • 1 - BAK/C Vista Interbody Fusion - peek-optima It1, Zimmer Spine, Inc (P980048 S003) (MAX)
  • 2 - BRANTIGEN I/F CAGE, DePuy Spine Inc, (P960025) (MAX)
  • 3 - LT-CAGE PEEK LUMBAR - peek-optima It1, Medtronic (P970015 S022) (MAX)
  • 4 - BAK INTERBODY LUMBAR FUSION - 65% peek optima/35% carbon fiber, Zimmer Spine (P950002 S011) (MAX)