510(k) · Cleared
Recalled · Class II · 2021Axle Interspinous Fusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
X-Spine Systems, Inc. · PEK Spinous Process Plate
Cleared on Jun 27, 2013 as substantially equivalent to K101471 (X-Spine Systems, Inc., 2010) and 3 other predicates after a 126-day review. Its family tree reaches back 6 generations to 1999. 18 later devices descend from it. It has been recalled once.
- Decided
- Jun 27, 2013
- Review
- 126 days
- Class
- Class II
- Product code
- PEK
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 6 generations to K990745 (1999). 26 ancestors in all, the oldest K781443 (1978). 18 later devices descend from it, 6 citing it directly.
- Root · 6 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 5 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
- 4 generations backK052123 Synthes Pangea SystemSynthes (Usa) · 2005
- 3 generations backK082572 Uss Iliosacral, Uss PolyaxialSynthes Spine · 2008
- 2 generations backK091445 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2010
- 1 generation backK101471 Axle Interspinous Fusion SystemX-Spine Systems, Inc. · 2010 · Recalled
- This deviceK130438 Axle Interspinous Fusion SystemX-Spine Systems, 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 · 2 generations on · 5 of its ownK212781 Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS…Spinal Simplicity, LLC · 2021
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
- 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 |
|---|---|---|---|---|---|
| −6 | K990745 | Modification to Synthes Universal Spinal System | Synthes Spine | 1999 | — |
| −5 | K992739 | Click'x | Synthes Spine | 2000 | 1 |
| −4 | K052123 | Synthes Pangea System | Synthes (Usa) | 2005 | — |
| −3 | K082572 | Uss Iliosacral, Uss Polyaxial | Synthes Spine | 2008 | — |
| −2 | K091445 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −1 | K101471 | Axle Interspinous Fusion System | X-Spine Systems, Inc. | 2010 | 1 |
| 0 (this device) | K130438 | Axle Interspinous Fusion System | X-Spine Systems, 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 | — |
| +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 |
|---|---|---|
| 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 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 5 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 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? (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 |
|---|---|---|---|
| * | K101471 | Axle Interspinous Fusion SystemSummary page 2…ended Uses e Surgical Approach * Anatomical Region o Implant Materials ¢ Product Features PREDICATE DEVICES ¢ X-spine Systems, Inc. - Axle Interspinous Fusion System (K101471) ¢ X-spine Systems, Inc. - Axle PEEK Interspinous Fusion System (K112592) ¢ Medtronic-Sofamor-Danek—CD Horizon Spinal System Sp… | 2010 |
| * | K112592 | Axle Peek Interspinous Fusion SystemSummary page 2…Product Features PREDICATE DEVICES ¢ X-spine Systems, Inc. - Axle Interspinous Fusion System (K101471) ¢ X-spine Systems, Inc. - Axle PEEK Interspinous Fusion System (K112592) ¢ Medtronic-Sofamor-Danek—CD Horizon Spinal System Spire Spinous Process Plate (K091445) e Lanx, LLC - Aspen Spinous Process F… | 2011 |
| * | K091445 | CD Horizon Spinal SystemSummary page 2…stem (K101471) ¢ X-spine Systems, Inc. - Axle PEEK Interspinous Fusion System (K112592) ¢ Medtronic-Sofamor-Danek—CD Horizon Spinal System Spire Spinous Process Plate (K091445) e Lanx, LLC - Aspen Spinous Process Fusion Plate (K071877) PERFORMANCE COMPARISON The implant components were tested usihg the… | 2010 |
| * | K071877 | Lanx Spinal Fixation SystemSummary page 2…nous Fusion System (K112592) ¢ Medtronic-Sofamor-Danek—CD Horizon Spinal System Spire Spinous Process Plate (K091445) e Lanx, LLC - Aspen Spinous Process Fusion Plate (K071877) PERFORMANCE COMPARISON The implant components were tested usihg the following standards: ASTM F1717 — Standard Test Methods fo… | 2007 |
What descends from it? (18)
See all 186 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140046 | Spinous Process Fusion (SPF) Plate | 2015 | 9 |
| K151863 | Precision Spine Interspinous Plate System | 2015 | 2 |
| K141508 | Romeo 2 Pad Posterior Axial Device | 2014 | 1 |
| K232484 | KeyLift™ Expandable Interlaminar Stabilization System | 2023 | 0 |
| K143631 | Benefix Interspinous Fixation System | 2015 | 0 |
| K143388 | Affix IIS Spinous Process Plate System | 2015 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 29, 2021 | Class II | Z-0533-2022 | Under Investigation by firm | The proximal opening of the inserts exhibit an out of specification condition which would prevent the crossbar plates from appropriately engaging with the insert. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
- 3 of the 26 ancestors have a recall of any class.
- Of its descendants, K140046 (Spinal Simplicity, LLC, 2015) has gone furthest, with 9 descendants of its own.
- 2 other devices also cite its predicate K101471.
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 Axle Interspinous Fusion System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1 inclusive). It is intended for plate fixation/attachment to spinous processes 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 Axle Interspinous Fusion System is intended for use with bone graft material, and not for stand-alone use.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K130438 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130438: Axle Interspinous Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130438
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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