510(k) Report

510(k) · Cleared

Cleared

Axle Peek Interspinous Fusion System

K112592510(k) SpecialCleared Dec 5, 201189-day reviewClass II21 CFR 888.3050

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

X-Spine Systems, Inc. · KWP Appliance, Fixation, Spinal Interlaminal

Cleared on Dec 5, 2011 after an 89-day review. The FDA summary names no predicate by number. 20 later devices descend from it.

Decided
Dec 5, 2011
Review
89 days
Class
Class II
Product code
KWP
Recalls
None
Predicates
0

20 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2013: 2 descendants cleared2014: 1 descendant cleared2015: 5 descendants cleared2023: 2 descendants cleared2016: 3 descendants cleared2021: 1 descendant cleared2022: 2 descendants cleared2020: 1 descendant cleared2017: 1 descendant cleared2024: 1 descendant cleared2025: 1 descendant cleared2010201520202025
  1. This deviceK112592 Axle Peek Interspinous Fusion SystemX-Spine Systems, Inc. · 2011
  2. Descendant · cites it directly · 18 of its ownK130438 Axle Interspinous Fusion SystemX-Spine Systems, Inc. · 2013 · Recalled
  3. Descendant · 2 generations on · 9 of its ownK140046 Spinous Process Fusion (SPF) PlateSpinal Simplicity, LLC · 2015
  4. Descendant · 3 generations on · 8 of its ownK151741 HA Minuteman G3 MIS Fusion PlateSpinal Simplicity, LLC · 2015
  5. Descendant · 4 generations on · 7 of its ownK163428 HA Minuteman G3-R MIS Fusion PlateSpinal Simplicity · 2017
  6. Descendant · 3 generations on · 6 of its ownK200066 Posterior Fusion Plate, HA Posterior Fusion PlateSpinal Simplicity, LLC · 2020

Showing 5 of 20 descendants. See all descendants

Descendants cleared per year

2013: 22014: 12015: 52016: 32017: 12020: 12021: 12022: 22023: 22024: 12025: 1
2013high 5 (2015) · low 0 (2018)2026

Most influential descendants

Showing 5 of 20 · See all
  • K130438Axle Interspinous Fusion SystemX-Spine Systems, Inc. · 2013 · cites it directly18descendants
  • K140046Spinous Process Fusion (SPF) PlateSpinal Simplicity, LLC · 2015 · 2 generations on9descendants
  • K151741HA Minuteman G3 MIS Fusion PlateSpinal Simplicity, LLC · 2015 · 3 generations on8descendants
  • K163428HA Minuteman G3-R MIS Fusion PlateSpinal Simplicity · 2017 · 4 generations on7descendants
  • K200066Posterior Fusion Plate, HA Posterior Fusion PlateSpinal Simplicity, LLC · 2020 · 3 generations on6descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K112592Axle Peek Interspinous Fusion SystemX-Spine Systems, Inc.2011—
+1K130438Axle Interspinous Fusion SystemX-Spine Systems, Inc.20131
+2K140046Spinous Process Fusion (SPF) PlateSpinal Simplicity, LLC2015—
+3K151741HA Minuteman G3 MIS Fusion PlateSpinal Simplicity, LLC2015—
+4K163428HA Minuteman G3-R MIS Fusion PlateSpinal Simplicity2017—
+3K200066Posterior Fusion Plate, HA Posterior Fusion PlateSpinal Simplicity, LLC2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201320
201410
201550
201630
201710
202010
202110
202220
202320
202410
202510
FIG. 1 — Lineage of K112592, 2011–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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
Get a 510(k) Report

What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (20)

See all 20

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K130438Axle Interspinous Fusion SystemX-Spine Systems, Inc.201318
K141508Romeo 2 Pad Posterior Axial DeviceSpineart20141
K130066Spectrum Spine Spinous Process DeviceSpectrum Spine IP Holdings, LLC20130

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?

  • Of its descendants, K130438 (X-Spine Systems, Inc., 2013) has gone furthest, with 18 descendants of its own.

How does its category compare?

All KWP devices

KWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · KWP

9in 2015

2007: 142008: 132009: 122010: 142011: 122012: 182013: 122014: 132015: 9
2007high 18 (2012) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWP

113in 2015

2007: 96 days median2008: 50 days median2009: 89 days median2010: 186 days median2011: 67 days median2012: 112 days median2013: 99 days median2014: 138 days median2015: 113 days median
2007high 186 (2010) · low 50 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KWP

2in 2022

2007: 22008: 12009: 232010: 22011: 62012: 12013: 32015: 12016: 32018: 12019: 22022: 2
2007high 23 (2009) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KWP

494in 2025

2007: 2102008: 5942009: 6822010: 4742011: 7922012: 9182013: 1,0902014: 1,0222015: 1,3482016: 1,3792017: 8642018: 6572019: 5182020: 7962021: 5252022: 3352023: 3322024: 4362025: 494
2007high 1,379 (2016) · low 210 (2007)2025

MAUDE reports naming product code KWP, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200714962210
200813501594
2009128923682
2010141862474
201112676792
2012181121918
2013129931,090
20141313801,022
2015911311,348
20160—31,379
20170—0864
20180—1657
20190—2518
20200—0796
20210—0525
20220—2335
20230—0332
20240—0436
20250—0494
20260—0—

What is it indicated for?

The Axle PEEK 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 PEEK 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.

More from X-Spine Systems, Inc.

34 FDA decisions under this applicant name. See the company

  • K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc. · 20181 recall
  • K180153X-spine Cortical Bone Screw SystemX-Spine Systems, Inc. · 2018
  • K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc. · 20171 recall
  • K171567IRIX-A Lumbar Integrated Fusion SystemX-Spine Systems, Inc. · 20171 recall
  • K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc. · 2017

Recent decisions in KWP

The KWP category page

  • K143278LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd. · 2015
  • K150753OASYS SystemStryker Corporation · 2015
  • K150851Sure Lok Mini Posterior Cervical/Upper Thoracic SystemPrecision Spine, Inc. · 2015
  • K142867Reliance Posterior Cervical-Thoracic SystemReliance Medical Systems, LLC · 2015
  • K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 20153 recalls

https://510kreport.com/device/K112592 · printed Nov 6, 2026

Cite this page

510(k) Report. “K112592: Axle Peek 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/K112592

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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