510(k) · Cleared
Recalled · 2011Axle Interspinous Fusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
X-Spine Systems, Inc. · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Nov 24, 2010 as substantially equivalent to K091445 (Medtronic Sofamor Danek, 2010) after a 181-day review. Its family tree reaches back 5 generations to 1999. 26 later devices descend from it. It has been recalled once.
- Decided
- Nov 24, 2010
- Review
- 181 days
- Class
- Class II
- Product code
- KWP
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 5 generations to K990745 (1999). 19 ancestors in all, the oldest K781443 (1978). 26 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 4 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
- 3 generations backK052123 Synthes Pangea SystemSynthes (Usa) · 2005
- 2 generations backK082572 Uss Iliosacral, Uss PolyaxialSynthes Spine · 2008
- 1 generation backK091445 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2010
- This deviceK101471 Axle Interspinous Fusion SystemX-Spine Systems, Inc. · 2010
- Descendant · cites it directly · 18 of its ownK130438 Axle Interspinous Fusion SystemX-Spine Systems, Inc. · 2013 · Recalled
- Descendant · cites it directly · 18 of its ownK122509 Vertiflex Spinous Process Fixation PlateVertiflex, Inc. · 2012
- Descendant · 2 generations on · 12 of its ownK132968 Univise Spinous Process Fixation Plate (35MM, 40MM)Stryker Spine · 2013
- Descendant · 2 generations on · 9 of its ownK140046 Spinous Process Fusion (SPF) PlateSpinal Simplicity, LLC · 2015
- Descendant · 3 generations on · 8 of its ownK151741 HA Minuteman G3 MIS Fusion PlateSpinal Simplicity, LLC · 2015
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K130438Axle Interspinous Fusion SystemX-Spine Systems, Inc. · 2013 · cites it directly18descendants
- K122509Vertiflex Spinous Process Fixation PlateVertiflex, Inc. · 2012 · cites it directly18descendants
- K132968Univise Spinous Process Fixation Plate (35MM, 40MM)Stryker Spine · 2013 · 2 generations on12descendants
- K140046Spinous Process Fusion (SPF) PlateSpinal Simplicity, LLC · 2015 · 2 generations on9descendants
- K151741HA Minuteman G3 MIS Fusion PlateSpinal Simplicity, LLC · 2015 · 3 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K990745 | Modification to Synthes Universal Spinal System | Synthes Spine | 1999 | — |
| −4 | K992739 | Click'x | Synthes Spine | 2000 | 1 |
| −3 | K052123 | Synthes Pangea System | Synthes (Usa) | 2005 | — |
| −2 | K082572 | Uss Iliosacral, Uss Polyaxial | Synthes Spine | 2008 | — |
| −1 | K091445 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2010 | — |
| 0 (this device) | K101471 | Axle Interspinous Fusion System | X-Spine Systems, Inc. | 2010 | — |
| +1 | K130438 | Axle Interspinous Fusion System | X-Spine Systems, Inc. | 2013 | 1 |
| +1 | K122509 | Vertiflex Spinous Process Fixation Plate | Vertiflex, Inc. | 2012 | — |
| +2 | K132968 | Univise Spinous Process Fixation Plate (35MM, 40MM) | Stryker Spine | 2013 | — |
| +2 | K140046 | Spinous Process Fusion (SPF) Plate | Spinal Simplicity, LLC | 2015 | — |
| +3 | K151741 | HA Minuteman G3 MIS Fusion Plate | Spinal Simplicity, LLC | 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 | 2 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 6 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 3 | 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 KWP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K091445 | CD Horizon Spinal System Cleared while this submission was under review Summary page 2…that, for the purposes of FDA's regulation of medical devices, the Axle Interspinous Fusion System is substantially equivalent to the Medtronic CD Horizon Spinal System (K091445), specifically the Medtronic SPIRE Spinous Process Plate component, based on a technological comparison including the following c… | 2010 |
What descends from it? (26)
See all 263 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 15, 2011 | Not classified | Z-0034-2012 | Component design/selection | The firm learned that the Torque Driver Handles were not actuating at a proper torque. It was determined that the handles were speed determinant and could output a higher torque if the handles were turned at a very slow speed. |
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 1.8 years on median.
- 1 of the 19 ancestors has a recall of any class.
- Of its descendants, K130438 (X-Spine Systems, Inc., 2013) has gone furthest, with 18 descendants of its own.
- 26 other devices also cite its predicate K091445.
How does its category compare?
All KWP devicesKWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · KWP
9in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · KWP
113in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWP
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWP
494in 2025
MAUDE reports naming product code KWP, 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 | 14 | 96 | 2 | 210 |
| 2008 | 13 | 50 | 1 | 594 |
| 2009 | 12 | 89 | 23 | 682 |
| 2010 | 14 | 186 | 2 | 474 |
| 2011 | 12 | 67 | 6 | 792 |
| 2012 | 18 | 112 | 1 | 918 |
| 2013 | 12 | 99 | 3 | 1,090 |
| 2014 | 13 | 138 | 0 | 1,022 |
| 2015 | 9 | 113 | 1 | 1,348 |
| 2016 | 0 | — | 3 | 1,379 |
| 2017 | 0 | — | 0 | 864 |
| 2018 | 0 | — | 1 | 657 |
| 2019 | 0 | — | 2 | 518 |
| 2020 | 0 | — | 0 | 796 |
| 2021 | 0 | — | 0 | 525 |
| 2022 | 0 | — | 2 | 335 |
| 2023 | 0 | — | 0 | 332 |
| 2024 | 0 | — | 0 | 436 |
| 2025 | 0 | — | 0 | 494 |
| 2026 | 0 | — | 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 (TI-Si 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 as stated in the FDA summary.
https://510kreport.com/device/K101471 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101471: 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/K101471
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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