FDA Product Code PEK: Spinous Process Plate
A Posterior, Non-pedicle Supplemental Fixation Device Intended For Single Level Use In The Non-cervical Spine (t1-s1). It Is Intended For Single Level Plate Fixation/attachment To Spinous Process For The Purpose Of Achieving Supplemental Fusion In The Following Conditions: Degenerative Disc Disease (defined As Back Pain Of Discogenic Origin With Degeneration Of The Disc Confirmed By History And Radiographic Studies), Trauma (i.e., Fracture Or Dislocation), Spondylolisthesis, And/or Tumor. It Is Not Intended For Stand-alone Use.
Leading manufacturers include Spinal Simplicity, LLC and Wenzel Spine, Inc..
FDA 510(k) Cleared Spinous Process Plate Devices (Product Code PEK)
About Product Code PEK - Regulatory Context
510(k) Submission Activity
48 total 510(k) submissions under product code PEK since 2013, with 48 receiving FDA clearance (average review time: 133 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 7 in the prior period.
FDA Review Time
Recent submissions under PEK have taken an average of 63 days to reach a decision - down from 134 days historically, suggesting improved FDA processing for this classification.
PEK devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →