510(k) · Cleared
ClearedAffix (R) Next Gen Spinous Process Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nuvasive, Inc. · PEK Spinous Process Plate
Cleared on Dec 20, 2013 as substantially equivalent to K073278 (Nuvasive, Inc., 2008) and 2 other predicates after an 84-day review. Its family tree reaches back 5 generations to 2003. 18 later devices descend from it.
- Decided
- Dec 20, 2013
- Review
- 84 days
- Class
- Class II
- Product code
- PEK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K032037 (2003). 9 ancestors in all. 18 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK032037 CD Horizon (Addition of Spinous Process Plate)Medtronic Sofamor Danek · 2003
- 4 generations backK043053 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 3 generations backK071877 Lanx Spinal Fixation SystemLanx, LLC · 2007
- 2 generations backK100354 Primal OK Interspinous Fusion SystemOsteomed LP · 2010
- 1 generation backK131238 Affix Spinous Process Plate SystemNuvasive, Inc. · 2013
- This deviceK133052 Affix (R) Next Gen Spinous Process Plate SystemNuvasive, Inc. · 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 · cites it directly · 6 of its ownK163471 Kalitec Direct InSePtion™ MIS Fixation SystemKalitec Direct, LLC · 2017
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · 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
- K163471Kalitec Direct InSePtion™ MIS Fixation SystemKalitec Direct, LLC · 2017 · cites it directly6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K032037 | CD Horizon (Addition of Spinous Process Plate) | Medtronic Sofamor Danek | 2003 | — |
| −4 | K043053 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −3 | K071877 | Lanx Spinal Fixation System | Lanx, LLC | 2007 | — |
| −2 | K100354 | Primal OK Interspinous Fusion System | Osteomed LP | 2010 | — |
| −1 | K131238 | Affix Spinous Process Plate System | Nuvasive, Inc. | 2013 | — |
| 0 (this device) | K133052 | Affix (R) Next Gen Spinous Process Plate System | Nuvasive, Inc. | 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 | — |
| +1 | K163471 | Kalitec Direct InSePtion™ MIS Fixation System | Kalitec Direct, LLC | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 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? (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…ate Devices The subject Affix Next Gen Spinous Process Plate System is substantially equivalent to the predicate device, NuVasive Spinous Process Plate System (K073278), NuVasive Affix Spinous Process Plate System (K 13 1238) and Affix 11 Spinous Process Plate System (K 13241 1). D.… | 2008 |
| * | K131238 | Affix Spinous Process Plate SystemSummary page 1…Plate System is substantially equivalent to the predicate device, NuVasive Spinous Process Plate System (K073278), NuVasive Affix Spinous Process Plate System (K 13 1238) and Affix 11 Spinous Process Plate System (K 13241 1). D. Device Description The Affix Next Gen Spinous Process Pla… | 2013 |
| * | K132411 | Affix II Spinous Process Plate System Cleared while this submission was under review Summary page 1…ate device, NuVasive Spinous Process Plate System (K073278), NuVasive Affix Spinous Process Plate System (K 13 1238) and Affix 11 Spinous Process Plate System (K 13241 1). D. Device Description The Affix Next Gen Spinous Process Plate System is a posterior, non-pedicle supplemental fix… | 2013 |
What descends from it? (18)
See all 183 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 4 companies; a new generation was cleared every 2.4 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K140046 (Spinal Simplicity, LLC, 2015) has gone furthest, with 9 descendants of its own.
- 16 other devices also cite its predicate K073278.
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 Affix Next Gen Spinous Process Plate System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (TI - SI1). It is intended for plate fixation/attachment to the spinous process for the purpose of achieving supplemental fuision in the following conditions:
- Degenerative disc disease (DDD) - 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)
* Tumor
The Affix Next Gen Spinous Process Plate System is not intended for stand-alone use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133052 · printed Nov 5, 2026
Cite this page
510(k) Report. “K133052: Affix (R) Next Gen Spinous Process Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133052
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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