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 Jul 8, 2022 as substantially equivalent to K141317 (Aurora Spine, Inc., 2014) and 3 other predicates after a 56-day review. Its family tree reaches back 6 generations to 2003.
- Decided
- Jul 8, 2022
- Review
- 56 days
- Class
- Class II
- Product code
- PEK
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K032037 (2003). 13 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK032037 CD Horizon (Addition of Spinous Process Plate)Medtronic Sofamor Danek · 2003
- 5 generations backK043053 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 4 generations backK071877 Lanx Spinal Fixation SystemLanx, LLC · 2007
- 3 generations backK133091 Zip Mis Interspinous Fusion SystemAurora Spine · 2013
- 2 generations backK140715 Zip Mis Interspinous Fusion SystemAurora Spine, Inc. · 2014
- 1 generation backK141317 Zip Mis Interspinous Fusion SystemAurora Spine, Inc. · 2014
- This deviceK221399 ZIP™ MIS Interspinous Fusion SystemAurora Spine, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K032037 | CD Horizon (Addition of Spinous Process Plate) | Medtronic Sofamor Danek | 2003 | — |
| −5 | K043053 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −4 | K071877 | Lanx Spinal Fixation System | Lanx, LLC | 2007 | — |
| −3 | K133091 | Zip Mis Interspinous Fusion System | Aurora Spine | 2013 | — |
| −2 | K140715 | Zip Mis Interspinous Fusion System | Aurora Spine, Inc. | 2014 | — |
| −1 | K141317 | Zip Mis Interspinous Fusion System | Aurora Spine, Inc. | 2014 | — |
| 0 (this device) | 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 |
| 2010 | 1 | 0 |
| 2021 | 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? (4)
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 |
|---|---|---|---|
| * | K141317 | Zip Mis Interspinous Fusion SystemSummary page 5…Aurora Spine ZIP™ MIS Interspinous Fusion System with modified indications is substantially equivalent to the predicate Aurora Spine ZIP™ MIS Interspinous Fusion System (K141317, K140715, K133091) with respect to intended use, design, function, performance and materials. Additional Predicate Device: The A… | 2014 |
| * | K140715 | Zip Mis Interspinous Fusion SystemSummary page 5…ine ZIP™ MIS Interspinous Fusion System with modified indications is substantially equivalent to the predicate Aurora Spine ZIP™ MIS Interspinous Fusion System (K141317, K140715, K133091) with respect to intended use, design, function, performance and materials. Additional Predicate Device: The Aurora ZIP… | 2014 |
| * | K133091 | Zip Mis Interspinous Fusion SystemSummary page 5…MIS Interspinous Fusion System with modified indications is substantially equivalent to the predicate Aurora Spine ZIP™ MIS Interspinous Fusion System (K141317, K140715, K133091) with respect to intended use, design, function, performance and materials. Additional Predicate Device: The Aurora ZIP™ MIS Int… | 2013 |
| * | K213266 | Inspan ScrewLES Fusion SystemSummary page 5…performance and materials. Additional Predicate Device: The Aurora ZIP™ MIS Interspinous Fusion System is substantially equivalent to the InSpan ScrewLES Fusion System (K213266) with respect to intended use, design, function, performance, materials, and indications for use. Technological Characteristics:… | 2021 |
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 19 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- 1 of the 13 ancestors has a recall of any class.
- 1 other device also cites its predicate K141317.
How does its category compare?
All PEK devicesPEK Spinous Process Plate: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 ZIP™ MIS 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 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), lumbar spinal stenosis, spondylolisthesis, trauma (i.e., fracture or dislocation), and/or tumor. The Aurora Spine ZIP™ 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/K221399 · printed Nov 5, 2026
Cite this page
510(k) Report. “K221399: 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/K221399
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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