510(k) Report

510(k) · Cleared

Cleared

Vertiflex Spinous Process Fixation Plate

K122509510(k) TraditionalCleared Dec 17, 2012122-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

Vertiflex, Inc. · KWP Appliance, Fixation, Spinal Interlaminal

Cleared on Dec 17, 2012 as substantially equivalent to K073278 (Nuvasive, Inc., 2008) and 8 other predicates after a 122-day review. Its family tree reaches back 6 generations to 1999. 18 later devices descend from it.

Decided
Dec 17, 2012
Review
122 days
Class
Class II
Product code
KWP
Recalls
None
Predicates
9

Its longest line of descent runs back 6 generations to K990745 (1999). 30 ancestors in all, the oldest K781443 (1978). 18 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2012: 1 other ancestor2011: 1 other ancestor2010: 2 other ancestors2008: 2 other ancestors2007: 1 other ancestor2005: 2 other ancestors2003: 3 other ancestors2004: 1 other ancestor2000: 3 other ancestors2001: 3 other ancestors1998: 1 other ancestor1997: 1 other ancestor1996: 2 other ancestors1978: 1 other ancestor2014: 1 descendant cleared2015: 4 descendants cleared2013: 1 descendant cleared2022: 3 descendants cleared2016: 2 descendants cleared2021: 1 descendant cleared2020: 1 descendant cleared2023: 2 descendants cleared2017: 1 descendant cleared2024: 1 descendant cleared2025: 1 descendant clearedK990745 · Modification to Synthes Universal Spinal System · Synthes Spine · 1999K992739 · Click'x · Synthes Spine · 2000 · recalledK052123 · Synthes Pangea System · Synthes (Usa) · 2005K082572 · Uss Iliosacral, Uss Polyaxial · Synthes Spine · 2008×2: 2 generations cleared close together, K091445 (2010), K101471 (2010) 19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 8 other ancestors2 generations back: 1 other ancestor3 generations back: 3 other ancestors4 generations back: 10 other ancestors5 generations back: 2 other ancestors 1 generation forward: 3 descendants2 generations forward: 4 descendants3 generations forward: 6 descendants4 generations forward: 3 descendants5 generations forward: 1 descendant6 generations forward: 1 descendant K101471 · Axle Interspinous Fusion System · X-Spine Systems, Inc. · 2010 · recalledK091445 · CD Horizon Spinal System · Medtronic Sofamor Danek · 2010K082572 · Uss Iliosacral, Uss Polyaxial · Synthes Spine · 2008K052123 · Synthes Pangea System · Synthes (Usa) · 2005K992739 · Click'x · Synthes Spine · 2000 · recalledK990745 · Modification to Synthes Universal Spinal System · Synthes Spine · 1999−50+5
  1. Root · 6 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
  2. 5 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
  3. 4 generations backK052123 Synthes Pangea SystemSynthes (Usa) · 2005
  4. 3 generations backK082572 Uss Iliosacral, Uss PolyaxialSynthes Spine · 2008
  5. 2 generations backK091445 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2010
  6. 1 generation backK101471 Axle Interspinous Fusion SystemX-Spine Systems, Inc. · 2010 · Recalled
  7. This deviceK122509 Vertiflex Spinous Process Fixation PlateVertiflex, Inc. · 2012
  8. Descendant · cites it directly · 12 of its ownK132968 Univise Spinous Process Fixation Plate (35MM, 40MM)Stryker Spine · 2013
  9. Descendant · 2 generations on · 9 of its ownK140046 Spinous Process Fusion (SPF) PlateSpinal Simplicity, LLC · 2015
  10. Descendant · 3 generations on · 8 of its ownK151741 HA Minuteman G3 MIS Fusion PlateSpinal Simplicity, LLC · 2015
  11. Descendant · 4 generations on · 7 of its ownK163428 HA Minuteman G3-R MIS Fusion PlateSpinal Simplicity · 2017
  12. Descendant · 3 generations on · 6 of its ownK200066 Posterior Fusion Plate, HA Posterior Fusion PlateSpinal Simplicity, LLC · 2020

Showing 5 of 18 descendants. See all descendants

Descendants cleared per year

2013: 12014: 12015: 42016: 22017: 12020: 12021: 12022: 32023: 22024: 12025: 1
2013high 4 (2015) · low 0 (2018)2026

Most influential descendants

Showing 5 of 18 · See all
  • K132968Univise Spinous Process Fixation Plate (35MM, 40MM)Stryker Spine · 2013 · cites it directly12descendants
  • 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
−6K990745Modification to Synthes Universal Spinal SystemSynthes Spine1999—
−5K992739Click'xSynthes Spine20001
−4K052123Synthes Pangea SystemSynthes (Usa)2005—
−3K082572Uss Iliosacral, Uss PolyaxialSynthes Spine2008—
−2K091445CD Horizon Spinal SystemMedtronic Sofamor Danek2010—
−1K101471Axle Interspinous Fusion SystemX-Spine Systems, Inc.20101
0 (this device)K122509Vertiflex Spinous Process Fixation PlateVertiflex, Inc.2012—
+1K132968Univise Spinous Process Fixation Plate (35MM, 40MM)Stryker Spine2013—
+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—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
199620
199710
199810
200030
200130
200330
200410
200520
200710
200820
201020
201110
201210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201410
201540
201620
201710
202010
202110
202230
202320
202410
202510
FIG. 1 — Lineage of K122509, 1999–2025Source: 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
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What was it cleared against? (9)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K073278Spinous Process Plate System
Summary page 1
…evice is substantially equivalent, in whole or in part, to the following commercially available predicate devices: AffixTM~ Spinous Process Plate System (K073278; NuVasive, Inc.) AspenTM Spinal Fixation System (K071877, K100935; Lanx, LLC) AxieTM Interspinous Fusion System (…
Nuvasive, Inc.2008—
*K071877Lanx Spinal Fixation System
Summary page 1
…llowing commercially available predicate devices: AffixTM~ Spinous Process Plate System (K073278; NuVasive, Inc.) AspenTM Spinal Fixation System (K071877, K100935; Lanx, LLC) AxieTM Interspinous Fusion System (K101471; X-spine Systems, Inc.) PrimaLOKTM Interspinous F…
Lanx, LLC2007—
*K100935Lanx Spinal Fixation System
Summary page 1
…commercially available predicate devices: AffixTM~ Spinous Process Plate System (K073278; NuVasive, Inc.) AspenTM Spinal Fixation System (K071877, K100935; Lanx, LLC) AxieTM Interspinous Fusion System (K101471; X-spine Systems, Inc.) PrimaLOKTM Interspinous Fusion Sys…
Lanx, Inc.2010—
*K101471Axle Interspinous Fusion System
Summary page 1
…M~ Spinous Process Plate System (K073278; NuVasive, Inc.) AspenTM Spinal Fixation System (K071877, K100935; Lanx, LLC) AxieTM Interspinous Fusion System (K101471; X-spine Systems, Inc.) PrimaLOKTM Interspinous Fusion System (K100354; OsteoMed Spine, Inc.) SP-FixTM Spinous Pr…
X-Spine Systems, Inc.20101
*K100354Primal OK Interspinous Fusion System
Summary page 1
…l Fixation System (K071877, K100935; Lanx, LLC) AxieTM Interspinous Fusion System (K101471; X-spine Systems, Inc.) PrimaLOKTM Interspinous Fusion System (K100354; OsteoMed Spine, Inc.) SP-FixTM Spinous Process Fixation Plate (K 102195; Globus Medical, Inc.) SpireTM Spinous P…
Osteomed LP2010—
*K102195SP-Fix Spinous Process Fixation Plate
Summary page 1
…on System (K101471; X-spine Systems, Inc.) PrimaLOKTM Interspinous Fusion System (K100354; OsteoMed Spine, Inc.) SP-FixTM Spinous Process Fixation Plate (K 102195; Globus Medical, Inc.) SpireTM Spinous Process Plate (K032037, K043053, K102866; Medtronic, Inc.) 5.4 Device Descript…
Globus Medical, Inc.2011—
*K032037CD Horizon (Addition of Spinous Process Plate)
Summary page 1
…ous Fusion System (K100354; OsteoMed Spine, Inc.) SP-FixTM Spinous Process Fixation Plate (K 102195; Globus Medical, Inc.) SpireTM Spinous Process Plate (K032037, K043053, K102866; Medtronic, Inc.) 5.4 Device Description The VertiFlex® Spinous Process Fixation (SPF) Plate is a o…
Medtronic Sofamor Danek2003—
*K043053Modification to CD Horizon Spinal System
Summary page 1
…n System (K100354; OsteoMed Spine, Inc.) SP-FixTM Spinous Process Fixation Plate (K 102195; Globus Medical, Inc.) SpireTM Spinous Process Plate (K032037, K043053, K102866; Medtronic, Inc.) 5.4 Device Description The VertiFlex® Spinous Process Fixation (SPF) Plate is a one-piece…
Medtronic Sofamor Danek2005—
*DEN110002System 1E Process Biological Monitoring Kit
Our reading of the summary gave K102866, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN110002, System 1E Process Biological Monitoring Kit (STERIS Corporation), granted Mar 30, 2012; older De Novo requests were first filed under a 510(k) number, so this links to the grant.
STERIS Corporation2012—

Also cleared against K073278: 16 other devices →

What descends from it? (18)

See all 18

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

NumberDeviceApplicantDecidedDescendants
K132968Univise Spinous Process Fixation Plate (35MM, 40MM)Stryker Spine201312
K142378Interspinous Plate SystemPrecision Spine, Inc.20143
K142217Reliance Interspinous Plate SystemReliance Medical Systems, LLC20150

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 13 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
  • 3 of the 30 ancestors have a recall of any class.
  • Of its descendants, K132968 (Stryker Spine, 2013) has gone furthest, with 12 descendants of its own.
  • 16 other devices also cite its predicate K073278.

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. 2012, 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 VertiFlex® Spinous Process Fixation Plate is a posterior, non-pedicle supplemental fixation device intended for use at a single level in the non-cervical spine (T1 - S1). 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 VertiFlex® Spinous Process Fixation Plate is intended for use with bone graft, and is not intended for stand-alone use.

Indications for use as stated in the FDA summary.

Also cleared against K073278

16 other devices cite the same predicate.

  • K153302coflex-IFParadigm Spine, LLC · 2016
  • K142217Reliance Interspinous Plate SystemReliance Medical Systems, LLC · 2015
  • K142378Interspinous Plate SystemPrecision Spine, Inc. · 2014
  • K141508Romeo 2 Pad Posterior Axial DeviceSpineart · 2014
  • K133363Interbridge Interspinous Posterior Fixation SystemLdr Spine USA, Inc. · 2014
  • K133052Affix (R) Next Gen Spinous Process Plate SystemNuvasive, Inc. · 2013

More from Vertiflex, Inc.

5 FDA decisions under this applicant name. See the company

  • K122662Vertiflex Direct Decompression SystemVertiflex, Inc. · 2012
  • K082270Octane Vertebral Body Replacement (VBR) SystemVertiflex, Inc. · 2008
  • K073143Modified Vertiflex Spinal Screw SystemVertiflex, Inc. · 2008
  • K073245Extended Vertiflex Spinal Screw SystemVertiflex, Inc. · 2008

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/K122509 · printed Nov 6, 2026

Cite this page

510(k) Report. “K122509: Vertiflex Spinous Process Fixation Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122509

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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