510(k) · Cleared
ClearedprimaLOK™ SP Interspinous Fusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wenzel Spine, Inc. · PEK Spinous Process Plate
Cleared on Aug 15, 2023 as substantially equivalent to K213266 (Lespine Innovations, LLC, 2021) and 1 other predicate after a 56-day review. Its family tree reaches back 5 generations to 2003.
- Decided
- Aug 15, 2023
- Review
- 56 days
- Class
- Class II
- Product code
- PEK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K032037 (2003). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK032037 CD Horizon (Addition of Spinous Process Plate)Medtronic Sofamor Danek · 2003
- 4 generations backK043053 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 3 generations backK071877 Lanx Spinal Fixation SystemLanx, LLC · 2007
- 2 generations backK102020 Vega Span Spinous Process Plate SystemSpinefrontier, Inc. · 2010
- 1 generation backK213266 Inspan ScrewLES Fusion SystemLespine Innovations, LLC · 2021
- This deviceK231807 primaLOK™ SP Interspinous Fusion SystemWenzel Spine, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K032037 | CD Horizon (Addition of Spinous Process Plate) | Medtronic Sofamor Danek | 2003 | — |
| −4 | K043053 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −3 | K071877 | Lanx Spinal Fixation System | Lanx, LLC | 2007 | — |
| −2 | K102020 | Vega Span Spinous Process Plate System | Spinefrontier, Inc. | 2010 | — |
| −1 | K213266 | Inspan ScrewLES Fusion System | Lespine Innovations, LLC | 2021 | — |
| 0 (this device) | K231807 | primaLOK™ SP Interspinous Fusion System | Wenzel Spine, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PEK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PEK device
- #1 K253250 Minuteman® G6 MIS Fusion Platescore 15.2 · 17 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K213266 | Inspan ScrewLES Fusion SystemSummary page 4…5800 Date Prepared: August 9, 2023 Classifications: 21 CFR §888.3050 Class: II Product Codes: PEK Primary Predicate: K213266, LESpine Innovations, Inspan® ScrewLES® Fusion Additional Predicate: K100354, Wenzel Spine Inc., primaLOK™ SP Interspinous Fu… | 2021 |
| * | K100354 | Primal OK Interspinous Fusion SystemSummary page 4…8.3050 Class: II Product Codes: PEK Primary Predicate: K213266, LESpine Innovations, Inspan® ScrewLES® Fusion Additional Predicate: K100354, Wenzel Spine Inc., primaLOK™ SP Interspinous Fusion System… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 5 companies; a new generation was cleared every 2.4 years on median.
- 1 of the 11 ancestors has a recall of any class.
- 2 other devices also cite its predicate K213266.
How does its category compare?
All PEK devicesPEK Spinous Process Plate: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · PEK
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PEK
60in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PEK
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PEK
3in 2025
MAUDE reports naming product code PEK, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 10 | 118 | 0 | 0 |
| 2014 | 8 | 120 | 0 | 2 |
| 2015 | 6 | 166 | 0 | 3 |
| 2016 | 4 | 176 | 0 | 0 |
| 2017 | 3 | 94 | 0 | 0 |
| 2018 | 4 | 69 | 0 | 2 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 2 | — | 0 | 2 |
| 2021 | 2 | — | 1 | 17 |
| 2022 | 3 | 135 | 0 | 11 |
| 2023 | 4 | 60 | 0 | 8 |
| 2024 | 1 | — | 0 | 5 |
| 2025 | 1 | — | 0 | 3 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The primalLOK™ SP Interspinous Fusion System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). It is intended for 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), spondylolisthesis, trauma (i.e., fracture or dislocation), tumor, and/or lumbar spinal stenosis. The primalLOK™ SP Interspinous Fusion System is intended for use with bone graft material and not intended for stand-alone use.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K231807 · printed Nov 4, 2026
Cite this page
510(k) Report. “K231807: primaLOK™ SP Interspinous Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K231807
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026