510(k) · Cleared
ClearedVega Span Spinous Process Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spinefrontier, Inc. · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Sep 1, 2010 as substantially equivalent to K073278 (Nuvasive, Inc., 2008) and 2 other predicates after a 44-day review. Its family tree reaches back 3 generations to 2003. 8 later devices descend from it.
- Decided
- Sep 1, 2010
- Review
- 44 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K032037 (2003). 8 ancestors in all. 8 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK032037 CD Horizon (Addition of Spinous Process Plate)Medtronic Sofamor Danek · 2003
- 2 generations backK043053 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 1 generation backK071877 Lanx Spinal Fixation SystemLanx, LLC · 2007
- This deviceK102020 Vega Span Spinous Process Plate SystemSpinefrontier, Inc. · 2010
- Descendant · cites it directly · 3 of its ownK213266 Inspan ScrewLES Fusion SystemLespine Innovations, LLC · 2021
- Descendant · cites it directly · 3 of its ownK121316 Lanx Spinal Fization SystemLanx, Inc. · 2012
- Descendant · 2 generations on · 1 of its ownK131156 Lanx Spinal Fixation SystemLanx, Inc. · 2013
- Descendant · 2 generations on · 0 of its ownK232605 Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES…Lesspine Innovations · 2023
- Descendant · 2 generations on · 0 of its ownK231807 primaLOK™ SP Interspinous Fusion SystemWenzel Spine, Inc. · 2023
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K213266Inspan ScrewLES Fusion SystemLespine Innovations, LLC · 2021 · cites it directly3descendants
- K121316Lanx Spinal Fization SystemLanx, Inc. · 2012 · cites it directly3descendants
- K131156Lanx Spinal Fixation SystemLanx, Inc. · 2013 · 2 generations on1descendant
- K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations · 2023 · 2 generations on0descendants
- K231807primaLOK™ SP Interspinous Fusion SystemWenzel Spine, Inc. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K032037 | CD Horizon (Addition of Spinous Process Plate) | Medtronic Sofamor Danek | 2003 | — |
| −2 | K043053 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −1 | K071877 | Lanx Spinal Fixation System | Lanx, LLC | 2007 | — |
| 0 (this device) | K102020 | Vega Span Spinous Process Plate System | Spinefrontier, Inc. | 2010 | — |
| +1 | K213266 | Inspan ScrewLES Fusion System | Lespine Innovations, LLC | 2021 | — |
| +1 | K121316 | Lanx Spinal Fization System | Lanx, Inc. | 2012 | — |
| +2 | K131156 | Lanx Spinal Fixation System | Lanx, Inc. | 2013 | — |
| +2 | K232605 | Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System… | Lesspine Innovations | 2023 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 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 KWP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K073278 | Spinous Process Plate SystemSummary page 1…on Orthosis (21 CFR 888.3050), Class 11 Product Code: KWP 3. Predicate Devices K073278 - Nuvasive Spinous Process Plate System K071877 - Lanx Spinal Fixation System K050675 - DePuy Expedium Sp… | 2008 |
| * | K071877 | Lanx Spinal Fixation SystemSummary page 1…888.3050), Class 11 Product Code: KWP 3. Predicate Devices K073278 - Nuvasive Spinous Process Plate System K071877 - Lanx Spinal Fixation System K050675 - DePuy Expedium Spinous Process Plates 4. Device Description… | 2007 |
| * | K050675 | Expedium Spine System Spinous Process Fusion PlateSummary page 1…KWP 3. Predicate Devices K073278 - Nuvasive Spinous Process Plate System K071877 - Lanx Spinal Fixation System K050675 - DePuy Expedium Spinous Process Plates 4. Device Description The VegaTm SPAN#Tm Spinous Process Plate Sys… | 2005 |
What descends from it? (8)
2 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 7 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K213266 (Lespine Innovations, LLC, 2021) has gone furthest, with 3 descendants of its own.
- 16 other devices also cite its predicate K073278.
How does its category compare?
All KWP devicesKWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · KWP
9in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · KWP
113in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWP
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWP
494in 2025
MAUDE reports naming product code KWP, 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 | 14 | 96 | 2 | 210 |
| 2008 | 13 | 50 | 1 | 594 |
| 2009 | 12 | 89 | 23 | 682 |
| 2010 | 14 | 186 | 2 | 474 |
| 2011 | 12 | 67 | 6 | 792 |
| 2012 | 18 | 112 | 1 | 918 |
| 2013 | 12 | 99 | 3 | 1,090 |
| 2014 | 13 | 138 | 0 | 1,022 |
| 2015 | 9 | 113 | 1 | 1,348 |
| 2016 | 0 | — | 3 | 1,379 |
| 2017 | 0 | — | 0 | 864 |
| 2018 | 0 | — | 1 | 657 |
| 2019 | 0 | — | 2 | 518 |
| 2020 | 0 | — | 0 | 796 |
| 2021 | 0 | — | 0 | 525 |
| 2022 | 0 | — | 2 | 335 |
| 2023 | 0 | — | 0 | 332 |
| 2024 | 0 | — | 0 | 436 |
| 2025 | 0 | — | 0 | 494 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The VegaTm SPAN~m Spinous Process Plate 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, or degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies). 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/K102020 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102020: Vega Span Spinous Process Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102020
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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