FDA product code PEK: Spinous Process Plate
PEK is the FDA product code for spinous process plate. It is a Class II device, regulated under 21 CFR 888.3050 and reviewed by the Orthopedic panel. FDA has cleared 48 510(k) submissions under PEK, 9 in the last five years, from 32 different applicants. The average 510(k) review took 133 days (median 96); 46 days on average over the last three years. FDA has posted 1 recall for PEK devices, 1 initiated in the last five years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Spinous Process Plate |
| Device class | Class II |
| Regulation | 21 CFR 888.3050 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for PEK
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 3 | 93 |
| 2018 | 4 | 76 |
| 2020 | 2 | 188 |
| 2021 | 2 | 84 |
| 2022 | 3 | 151 |
| 2023 | 4 | 57 |
| 2024 | 1 | 28 |
| 2025 | 1 | 63 |
Compare with all 510(k) review times · Search every PEK clearance
Top PEK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Spinal Simplicity, LLC | 9 | 2025-12-01 |
| Aurora Spine, Inc. | 3 | 2022-07-08 |
| Globus Medical, Inc. | 3 | 2018-05-21 |
| Precision Spine, Inc. | 3 | 2016-05-04 |
| Nu Vasive, Incorporated | 2 | 2015-03-05 |
27 more applicants have PEK clearances. See the full list in Caduvo.
Most recent PEK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253250 | Spinal Simplicity, LLC | Minuteman® G6 MIS Fusion Plate | 2025-12-01 | 63 |
| K234051 | Spinal Simplicity, LLC | 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 | 2024-01-18 | 28 |
| K233527 | Spinal Simplicity, LLC | 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 | 2023-11-29 | 28 |
| K232484 | Amplio Spine, LLC | KeyLift Expandable Interlaminar Stabilization System | 2023-10-19 | 64 |
| K231807 | Wenzel Spine, Inc. | primaLOK SP Interspinous Fusion System | 2023-08-15 | 56 |
Recalls for PEK devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 0 still open. Most recent: 2021-12-29.
| Year | Recalls |
|---|---|
| 2021 | 1 |
Frequently asked questions
What is FDA product code PEK?
PEK is the FDA product code for spinous process plate. It is a Class II device, regulated under 21 CFR 888.3050 and reviewed by the Orthopedic panel.
What device class is PEK?
Class II, regulation 21 CFR 888.3050. Typical premarket route: 510(k).
How long does a 510(k) take for product code PEK?
Across 48 cleared submissions the average was 133 days from receipt to decision (median 96).
Which companies have the most PEK clearances?
Spinal Simplicity, LLC (9); Aurora Spine, Inc. (3); Globus Medical, Inc. (3); Precision Spine, Inc. (3); Nu Vasive, Incorporated (2).
Have PEK devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2021-12-29.
Next steps
- Run an FDA pathway report with predicate devices for product code PEK
- Run a recall and safety report across every PEK manufacturer
- Watch product code PEK for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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