PEK — Spinous Process Plate Class II
FDA product code PEK covers "Spinous Process Plate", a Class II medical device regulated under 21 CFR 888.3050. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PEK
- Device Class
- Class II
- Regulation Number
- 888.3050
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Definition
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253250 | spinal simplicity | Minuteman® G6 MIS Fusion Plate | December 1, 2025 |
| K234051 | spinal simplicity | Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA Posterior | January 18, 2024 |
| K233527 | spinal simplicity | Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterio | November 29, 2023 |
| K232484 | amplio spine | KeyLift Expandable Interlaminar Stabilization System | October 19, 2023 |
| K231807 | wenzel spine | primaLOK SP Interspinous Fusion System | August 15, 2023 |
| K223790 | dio medical | Huvex Interspinous Fusion System | March 9, 2023 |
| K221023 | spinal simplicity | Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman G3/HA | August 19, 2022 |
| K221399 | aurora spine | ZIP MIS Interspinous Fusion System | July 8, 2022 |
| K211880 | spinal simplicity | Minuteman G5 MIS Fusion Plate | March 11, 2022 |
| K212781 | spinal simplicity | Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion Plate, | December 15, 2021 |
| K213266 | lespine innovations | Inspan ScrewLES Fusion System | December 3, 2021 |
| K200066 | spinal simplicity | Posterior Fusion Plate, HA Posterior Fusion Plate | December 10, 2020 |
| K201704 | paradigm spine | CoFix System | August 4, 2020 |
| K182352 | medical designs | SP-LINK System | November 21, 2018 |
| K180817 | globus medical | AERIAL Interspinous Fixation | May 21, 2018 |
| K180156 | globus medical | SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation System | March 7, 2018 |
| K173334 | seaspine orthopedics corporation | SeaSpine Spinous Process System | February 22, 2018 |
| K163471 | kalitec direct | Kalitec Direct InSePtion MIS Fixation System | March 16, 2017 |
| K162849 | dio medical co | Huvex Interspinous Fixation System | February 16, 2017 |
| K163428 | spinal simplicity | HA Minuteman G3-R MIS Fusion Plate | February 2, 2017 |