510(k) · Cleared
ClearedInspan ScrewLES Fusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lespine Innovations, LLC · PEK Spinous Process Plate
Cleared on Dec 3, 2021 as substantially equivalent to K102020 (Spinefrontier, Inc., 2010) after a 64-day review. Its family tree reaches back 4 generations to 2003. 3 later devices descend from it.
- Decided
- Dec 3, 2021
- Review
- 64 days
- Class
- Class II
- Product code
- PEK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K032037 (2003). 9 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK032037 CD Horizon (Addition of Spinous Process Plate)Medtronic Sofamor Danek · 2003
- 3 generations backK043053 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 2 generations backK071877 Lanx Spinal Fixation SystemLanx, LLC · 2007
- 1 generation backK102020 Vega Span Spinous Process Plate SystemSpinefrontier, Inc. · 2010
- This deviceK213266 Inspan ScrewLES Fusion SystemLespine Innovations, LLC · 2021
- Descendant · cites it directly · 0 of its ownK232605 Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES…Lesspine Innovations · 2023
- Descendant · cites it directly · 0 of its ownK231807 primaLOK™ SP Interspinous Fusion SystemWenzel Spine, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK221399 ZIP™ MIS Interspinous Fusion SystemAurora Spine, Inc. · 2022
Most influential descendants
Showing 3 of 3 · See all- K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations · 2023 · cites it directly0descendants
- K231807primaLOK™ SP Interspinous Fusion SystemWenzel Spine, Inc. · 2023 · cites it directly0descendants
- K221399ZIP™ MIS Interspinous Fusion SystemAurora Spine, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K032037 | CD Horizon (Addition of Spinous Process Plate) | Medtronic Sofamor Danek | 2003 | — |
| −3 | K043053 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −2 | K071877 | Lanx Spinal Fixation System | Lanx, LLC | 2007 | — |
| −1 | K102020 | Vega Span Spinous Process Plate System | Spinefrontier, Inc. | 2010 | — |
| 0 (this device) | K213266 | Inspan ScrewLES Fusion System | Lespine Innovations, LLC | 2021 | — |
| +1 | K232605 | Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System… | Lesspine Innovations | 2023 | — |
| +1 | K231807 | primaLOK™ SP Interspinous Fusion System | Wenzel Spine, Inc. | 2023 | — |
| +1 | K221399 | ZIP™ MIS Interspinous Fusion System | Aurora Spine, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 2 | 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? (1)
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 |
|---|---|---|---|
| * | K102020 | Vega Span Spinous Process Plate SystemSummary page 4…e is intended for use with bone graft material and is not intended for stand-alone use. Device Description: The Inspan ScrewLES Fusion System, previously cleared (under K102020) and marketed as, “VegaTM SPANTM Spinous Process Plate System”, consists of plates of varying length and hub diameters, set screw… | 2010 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 18 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K232605 (Lesspine Innovations, 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K102020.
How does its category compare?
All PEK devicesPEK Spinous Process Plate: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 Inspan ScrewLES Fusion System is a posterior non-pedicle supplemental fixation system intended for use in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to the spinous process for the purpose of achieving supplemental fusion for the following indications: spondylolisthesis, trauma (fracture or dislocation), tumor, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), or lumbar spinal stenosis. The device is intended for use with bone graft material and is not intended for stand-alone use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213266 · printed Nov 4, 2026
Cite this page
510(k) Report. “K213266: Inspan ScrewLES 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/K213266
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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