Cascadia Interbody System

K150481MAX8/20/2015

Applicant

K2M, Inc.

Intended Use

The system functions as an intervertebral body fusion device to provide support and stabilization of the lumbar segments of the spine.

Indications for Use

The CASCADIA implants are indicated for use with autogenous bone graft as intervertebral body fusion devices in skeletally mature patients. The implants are intended for use at either one level or two contiguous levels, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar implants are intended to be used in patients who have had six months of non-operative treatment. For all the above indications the CASCADIA implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including K2M Pedicle Screw and Hook Systems, and K2M Spinal Plate Systems.

Predicate Devices

  • K082698 - K2M Aleutian IBF Spinal System (MAX)
  • K110843 - K2M Aleutian IBF Spinal System (MAX)
  • K113561 - Zimmer TM Ardis (MAX)
  • K112316 - 4WEB STS (MAX)
  • K100945 - Advanced Medical Technology Fuse (MAX)
  • K141405 - Signus Mobis II ST (MAX)