KINEFLEX FDA PANEL MEETING CANCELLED (Orthopedics This Week)
SpinalMotion, Inc.’s two-day FDA orthopedic panel meeting scheduled July 24 and 25, 2013 has been cancelled.
The FDA announced the cancellation on July 11 without comment. The company told us they have no comment on the cancellation.
The company was to present evidence of the safety and effectiveness of the Kineflex/C Cervical and the Kineflex Lumbar Artificial Discs.
The Kineflex/C is a metal-on-metal (cobalt chrome molybdenum alloy) cervical total disc replacement device. The device is indicated for reconstruction of the intervertebral disc at one level from C3-C7 following single-level discectomy for intractable radiculopathy or myelopathy due to a single-level abnormality localized to the disc space.
The Kineflex Lumbar disc is a metal-on-metal (cobalt chrome molybdenum alloy) lumbar total disc replacement device. The device is indicated for reconstruction of the intervertebral disc at one level (L4-L5 or L5-S1) following single-level discectomy for lumbar degenerative disc disease (DDD) where DDD is defined as discogenic back pain with degeneration of the disc as confirmed by patient history, physical examination, an...
