PEK · Spinous Process Plate
Orthopedic · 21 CFR 888.3050 · Class 2
Overview
| Product Code | PEK |
|---|---|
| Device Name | Spinous Process Plate |
| Regulation | 21 CFR 888.3050 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 48)
Showing 20 most recent of 48 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253250 | Minuteman® G6 MIS Fusion Plate | Spinal Simplicity, LLC | Dec 1, 2025 | SESE |
| K234051 | Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3 | Spinal Simplicity, LLC | Jan 18, 2024 | SESE |
| K233527 | Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3 MIS Fusion Plate | Spinal Simplicity, LLC | Nov 29, 2023 | SESE |
| K232484 | KeyLift Expandable Interlaminar Stabilization System | Flospine | Oct 19, 2023 | SESE |
| K231807 | primaLOK SP Interspinous Fusion System | Wenzel Spine, Inc. | Aug 15, 2023 | SESE |
| K223790 | Huvex Interspinous Fusion System | Dio Medical Corp. | Mar 9, 2023 | SESE |
| K221023 | Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman G3/HA Minuteman G3, HA Minuteman G3-R, Minuteman G5 | Spinal Simplicity, LLC | Aug 19, 2022 | SESE |
| K221399 | ZIP MIS Interspinous Fusion System | Aurora Spine, Inc. | Jul 8, 2022 | SESE |
| K211880 | Minuteman G5 MIS Fusion Plate | Spinal Simplicity, LLC | Mar 11, 2022 | SESE |
| K212781 | 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 | Dec 15, 2021 | SESE |
| K213266 | Inspan ScrewLES Fusion System | Lespine Innovations, LLC | Dec 3, 2021 | SESE |
| K200066 | Posterior Fusion Plate, HA Posterior Fusion Plate | Spinal Simplicity, LLC | Dec 10, 2020 | SESE |
| K201704 | CoFix System | Paradigm Spine GmbH | Aug 4, 2020 | SESE |
| K182352 | SP-LINK System | Medical Designs, LLC | Nov 21, 2018 | SESE |
| K180817 | AERIAL Interspinous Fixation | Globus Medical, Inc. | May 21, 2018 | SESE |
| K180156 | SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation System | Globus Medical, Inc. | Mar 7, 2018 | SESE |
| K173334 | SeaSpine Spinous Process System | SeaSpine Orthopedics Corporation | Feb 22, 2018 | SESE |
| K163471 | Kalitec Direct InSePtion MIS Fixation System | Kalitec Direct, LLC | Mar 16, 2017 | SESE |
| K162849 | Huvex Interspinous Fixation System | Dio Medical Co., Ltd. | Feb 16, 2017 | SESE |
| K163428 | HA Minuteman G3-R MIS Fusion Plate | Spinal Simplicity | Feb 2, 2017 | SESE |
Top Applicants
- Spinal Simplicity, LLC — 9 clearances
- Precision Spine, Inc. — 3 clearances
- Globus Medical, Inc. — 3 clearances
- Aurora Spine, Inc. — 3 clearances
- Nuvasive, Inc. — 2 clearances
