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, Globus Medical, Inc. and Aurora Spine, Inc..
49
Total
49
Cleared
133d
Avg days
2013
Since
Declining activity -
2 submissions in the last 2 years
vs 5 in the prior period
Review times improving: avg
102d
recently vs 134d historically
FDA 510(k) Cleared Spinous Process Plate Devices (Product Code PEK)
49 devices
Cleared
Oct 02, 2026
Minuteman G6 MIS Fusion Plate
Spinal Simplicity, LLC
Orthopedic
141d
Cleared
Dec 01, 2025
Minuteman® G6 MIS Fusion Plate
Spinal Simplicity, LLC
Orthopedic
63d
Cleared
Jan 18, 2024
Minuteman G5 MIS Fusion Plate
Spinal Simplicity, LLC
Orthopedic
28d
Cleared
Nov 29, 2023
Minuteman G5 MIS Fusion Plate
Spinal Simplicity, LLC
Orthopedic
28d
Cleared
Oct 19, 2023
KeyLift™ Expandable Interlaminar Stabilization System
Flospine
Orthopedic
64d
Cleared
Aug 15, 2023
primaLOK™ SP Interspinous Fusion System
Wenzel Spine, Inc.
Orthopedic
56d
Cleared
Mar 09, 2023
Huvex Interspinous Fusion System
Dio Medical Corp.
Orthopedic
80d
Cleared
Aug 19, 2022
Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman G3/HA Minuteman G3, HA Minuteman G3-R, Minuteman G5
Spinal Simplicity, LLC
Orthopedic
135d
Cleared
Jul 08, 2022
ZIP™ MIS Interspinous Fusion System
Aurora Spine, Inc.
Orthopedic
56d
Cleared
Mar 11, 2022
Minuteman G5 MIS Fusion Plate
Spinal Simplicity, LLC
Orthopedic
263d
Cleared
Dec 15, 2021
Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion Plate, HA Minuteman G3 MIS Fusion Plate, HA Minuteman G3-R MIS Fusion Plate
Spinal Simplicity, LLC
Orthopedic
105d
Cleared
Dec 03, 2021
Inspan ScrewLES Fusion System
Lespine Innovations, LLC
Orthopedic
64d
Cleared
Dec 10, 2020
Posterior Fusion Plate, HA Posterior Fusion Plate
Spinal Simplicity, LLC
Orthopedic
332d
Cleared
Aug 04, 2020
CoFix System
Paradigm Spine GmbH
Orthopedic
43d
Cleared
Nov 21, 2018
SP-LINK™ System
Medical Designs, LLC
Orthopedic
84d
Cleared
May 21, 2018
AERIAL™ Interspinous Fixation
Globus Medical, Inc.
Orthopedic
53d
Cleared
Mar 07, 2018
SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation System
Globus Medical, Inc.
Orthopedic
47d
Cleared
Feb 22, 2018
SeaSpine Spinous Process System
SeaSpine Orthopedics Corporation
Orthopedic
122d
Cleared
Mar 16, 2017
Kalitec Direct InSePtion™ MIS Fixation System
Kalitec Direct, LLC
Orthopedic
94d
Cleared
Feb 16, 2017
Huvex Interspinous Fixation System
Dio Medical Co., Ltd.
Orthopedic
128d
Cleared
Feb 02, 2017
HA Minuteman G3-R MIS Fusion Plate
Spinal Simplicity
Orthopedic
58d
Cleared
Oct 19, 2016
Z-Clamp ISP System
Zavation, LLC
Orthopedic
191d
Cleared
Sep 08, 2016
coflex-IF
Paradigm Spine, LLC
Orthopedic
300d
Cleared
Jul 28, 2016
Spinal Elements' Spinous Process Plate System
Spinal Elements, Inc.
Orthopedic
160d
About Product Code PEK - Regulatory Context
510(k) Submission Activity
49 total 510(k) submissions under product code PEK since 2013, with 49 receiving FDA clearance (average review time: 133 days).
Submission volume has declined in recent years - 2 submissions in the last 24 months compared to 5 in the prior period.
FDA 510(k) Review Time - PEK Product Code
Recent submissions under PEK have taken an average of 102 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 →