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, Inc. · PEK Spinous Process Plate
Cleared on Apr 17, 2014 as substantially equivalent to K133091 (Aurora Spine, 2013) after a 27-day review. Its family tree reaches back 4 generations to 2003. 3 later devices descend from it.
- Decided
- Apr 17, 2014
- Review
- 27 days
- Class
- Class II
- Product code
- PEK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K032037 (2003). 7 ancestors in all. 3 later devices descend from it, 2 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 backK133091 Zip Mis Interspinous Fusion SystemAurora Spine · 2013
- This deviceK140715 Zip Mis Interspinous Fusion SystemAurora Spine, Inc. · 2014
- Descendant · cites it directly · 2 of its ownK141317 Zip Mis Interspinous Fusion SystemAurora Spine, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK221399 ZIP™ MIS Interspinous Fusion SystemAurora Spine, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK173334 SeaSpine Spinous Process SystemSeaSpine Orthopedics Corporation · 2018
Most influential descendants
Showing 3 of 3 · See all- K141317Zip Mis Interspinous Fusion SystemAurora Spine, Inc. · 2014 · cites it directly2descendants
- K221399ZIP™ MIS Interspinous Fusion SystemAurora Spine, Inc. · 2022 · cites it directly0descendants
- K173334SeaSpine Spinous Process SystemSeaSpine Orthopedics Corporation · 2018 · 2 generations on0descendants
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 | K133091 | Zip Mis Interspinous Fusion System | Aurora Spine | 2013 | — |
| 0 (this device) | K140715 | Zip Mis Interspinous Fusion System | Aurora Spine, Inc. | 2014 | — |
| +1 | K141317 | Zip Mis Interspinous Fusion System | Aurora Spine, Inc. | 2014 | — |
| +1 | K221399 | ZIP™ MIS Interspinous Fusion System | Aurora Spine, Inc. | 2022 | — |
| +2 | K173334 | SeaSpine Spinous Process System | SeaSpine Orthopedics Corporation | 2018 | — |
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 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 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? (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 |
|---|---|---|---|
| * | K133091 | Zip Mis Interspinous Fusion SystemSummary page 2…e Device: The modified Aurora Spine ZIPTM MIS Interspinious Fusion System is substantially equivalent to the predicate Aurora Spine ZIPTM MIS Interspinous Fusion System (K 133091) with respect to indications, design, function, performance and materials. Substantial Equivalence: Finite element analysis (FEA… | 2013 |
What descends from it? (3)
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 11 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K141317 (Aurora Spine, Inc., 2014) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K133091.
How does its category compare?
All PEK devicesPEK Spinous Process Plate: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 ZIPTM MIS Interspinous Fusion System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (Ti-SI). It is intended for plate fixation/attachment to the 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), and/or tumor. The Aurora Spine ZIPTM MIS Interspinous Fusion System 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/K140715 · printed Nov 5, 2026
Cite this page
510(k) Report. “K140715: Zip Mis Interspinous Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K140715
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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