510(k) · Cleared
ClearedZip Mis Interspinous Fusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aurora Spine · PEK Spinous Process Plate
Cleared on Nov 27, 2013 as substantially equivalent to K071877 (Lanx, LLC, 2007) and 1 other predicate after a 58-day review. Its family tree reaches back 3 generations to 2003. 14 later devices descend from it.
- Decided
- Nov 27, 2013
- Review
- 58 days
- Class
- Class II
- Product code
- PEK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K032037 (2003). 6 ancestors in all. 14 later devices descend from it, 4 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 deviceK133091 Zip Mis Interspinous Fusion SystemAurora Spine · 2013
- Descendant · cites it directly · 9 of its ownK140046 Spinous Process Fusion (SPF) PlateSpinal Simplicity, LLC · 2015
- Descendant · 2 generations on · 8 of its ownK151741 HA Minuteman G3 MIS Fusion PlateSpinal Simplicity, LLC · 2015
- Descendant · 3 generations on · 7 of its ownK163428 HA Minuteman G3-R MIS Fusion PlateSpinal Simplicity · 2017
- Descendant · 2 generations on · 6 of its ownK200066 Posterior Fusion Plate, HA Posterior Fusion PlateSpinal Simplicity, LLC · 2020
- Descendant · 2 generations on · 5 of its ownK212781 Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS…Spinal Simplicity, LLC · 2021
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K140046Spinous Process Fusion (SPF) PlateSpinal Simplicity, LLC · 2015 · cites it directly9descendants
- K151741HA Minuteman G3 MIS Fusion PlateSpinal Simplicity, LLC · 2015 · 2 generations on8descendants
- K163428HA Minuteman G3-R MIS Fusion PlateSpinal Simplicity · 2017 · 3 generations on7descendants
- K200066Posterior Fusion Plate, HA Posterior Fusion PlateSpinal Simplicity, LLC · 2020 · 2 generations on6descendants
- K212781Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion Plate, HA…Spinal Simplicity, LLC · 2021 · 2 generations on5descendants
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) | K133091 | Zip Mis Interspinous Fusion System | Aurora Spine | 2013 | — |
| +1 | K140046 | Spinous Process Fusion (SPF) Plate | Spinal Simplicity, LLC | 2015 | — |
| +2 | K151741 | HA Minuteman G3 MIS Fusion Plate | Spinal Simplicity, LLC | 2015 | — |
| +3 | K163428 | HA Minuteman G3-R MIS Fusion Plate | Spinal Simplicity | 2017 | — |
| +2 | K200066 | Posterior Fusion Plate, HA Posterior Fusion Plate | Spinal Simplicity, LLC | 2020 | — |
| +2 | K212781 | Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion… | Spinal Simplicity, LLC | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K071877 | Lanx Spinal Fixation System | 2007 |
| * | K073278 | Spinous Process Plate SystemSummary page 2…d has the same indications, for use, design, function, and materials used. These devices include the Lanx Spinous Process Fusion Plate (K071l877) and the NuVasive Afflx (K073278). Performance Standards: Testing performed on this device indicates that the Aurora Spine ZIPUM MIS Interspinous Fusion System i… | 2008 |
What descends from it? (14)
See all 144 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 10 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K140046 (Spinal Simplicity, LLC, 2015) has gone furthest, with 9 descendants of its own.
- 17 other devices also cite its predicate K071877.
How does its category compare?
All PEK devicesPEK Spinous Process Plate: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 Aurora Spine ZIPTAI MIS Interspinlous Fusion System is a posterior. non-pedicle supplemental fixation device. intended for u.se nta Single level in the non-cervical spine (TI -SI). It is intended for plate flxaiion/attachmnein to tile spinlous Process for the purpose of achieving supplemental fusion ill thle f'ollowin± conditions: degenerative disc disease (deflned as back pain ol' discogenic origin wvith degeneration of' the disc confirmed by…
Read the full statement (100 words)
The Aurora Spine ZIPTAI MIS Interspinlous Fusion System is a posterior. non-pedicle supplemental fixation device. intended for u.se nta Single level in the non-cervical spine (TI -SI). It is intended for plate flxaiion/attachmnein to tile spinlous Process for the purpose of achieving supplemental fusion ill thle f'ollowin± conditions: degenerative disc disease (deflned as back pain ol' discogenic origin wvith degeneration of' the disc confirmed by history and radiographic studies). spondvlolisthiesis. traumna (i.e.. fracture or dislocation), and/or tumor. The Aurora Spine ZI11iNI MIS Inierspinlots Fusion Systemn is intended lfor 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/K133091 · printed Nov 4, 2026
Cite this page
510(k) Report. “K133091: Zip Mis 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/K133091
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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