510(k) · Cleared
ClearedAffix IIS Spinous Process Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nu Vasive, Incorporated · PEK Spinous Process Plate
Cleared on Mar 5, 2015 as substantially equivalent to K132411 (Nu Vasive, Incorporated, 2013) and 2 other predicates after a 99-day review. Its family tree reaches back 7 generations to 1999.
- Decided
- Mar 5, 2015
- Review
- 99 days
- Class
- Class II
- Product code
- PEK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K990745 (1999). 39 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet.
- Root · 7 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 6 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
- 5 generations backK052123 Synthes Pangea SystemSynthes (Usa) · 2005
- 4 generations backK082572 Uss Iliosacral, Uss PolyaxialSynthes Spine · 2008
- 3 generations backK091445 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2010
- 2 generations backK101471 Axle Interspinous Fusion SystemX-Spine Systems, Inc. · 2010 · Recalled
- 1 generation backK130438 Axle Interspinous Fusion SystemX-Spine Systems, Inc. · 2013 · Recalled
- This deviceK143388 Affix IIS Spinous Process Plate SystemNu Vasive, Incorporated · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K990745 | Modification to Synthes Universal Spinal System | Synthes Spine | 1999 | — |
| −6 | K992739 | Click'x | Synthes Spine | 2000 | 1 |
| −5 | K052123 | Synthes Pangea System | Synthes (Usa) | 2005 | — |
| −4 | K082572 | Uss Iliosacral, Uss Polyaxial | Synthes Spine | 2008 | — |
| −3 | K091445 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −2 | K101471 | Axle Interspinous Fusion System | X-Spine Systems, Inc. | 2010 | 1 |
| −1 | K130438 | Axle Interspinous Fusion System | X-Spine Systems, Inc. | 2013 | 1 |
| 0 (this device) | K143388 | Affix IIS Spinous Process Plate System | Nu Vasive, Incorporated | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 4 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | K132411 | Affix II Spinous Process Plate SystemSummary page 4…evices The subject Affix IIS Spinous Process Plate System is substantially equivalent to the primary predicate device, NuVasive Affix II Spinous Process Plate (K132411) and additional predicate devices Lanx Spinous Process Fusion Plate (K121940) and Axle Interspinous Fusion System (K130… | 2013 |
| * | K121940 | Lanx Spinal Fixation SystemSummary page 4…uivalent to the primary predicate device, NuVasive Affix II Spinous Process Plate (K132411) and additional predicate devices Lanx Spinous Process Fusion Plate (K121940) and Axle Interspinous Fusion System (K130438). D. Device Description The Affix IIS Spinous Process Plate System is… | 2012 |
| * | K130438 | Axle Interspinous Fusion SystemSummary page 4…sive Affix II Spinous Process Plate (K132411) and additional predicate devices Lanx Spinous Process Fusion Plate (K121940) and Axle Interspinous Fusion System (K130438). D. Device Description The Affix IIS Spinous Process Plate System is a posterior, non-pedicle supplemental fixation… | 2013 |
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 16 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 4 of the 39 ancestors have a recall of any class.
- 2 other devices also cite its predicate K132411.
How does its category compare?
All PEK devicesPEK Spinous Process Plate: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 IIS Spinous Process Plate System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the lumbosacral spine (L1 – 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 (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 IIS Spinous Process Plate System is not intended for stand-alone use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143388 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143388: Affix IIS 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/K143388
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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