510(k) Report

510(k) · Cleared

Cleared

Spinous Process Plate System

K073278510(k) TraditionalCleared Mar 28, 2008128-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

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

Cleared on Mar 28, 2008 after a 128-day review. The FDA summary names no predicate by number. 58 later devices descend from it.

Decided
Mar 28, 2008
Review
128 days
Class
Class II
Product code
KWP
Recalls
None
Predicates
0

58 later devices descend from it, 17 citing it directly.

Descendants, by year cleared 2011: 3 descendants cleared2014: 7 descendants cleared2010: 2 descendants cleared2015: 5 descendants cleared2013: 9 descendants cleared2016: 4 descendants cleared2012: 3 descendants cleared2021: 3 descendants cleared2018: 3 descendants cleared2017: 2 descendants cleared2022: 4 descendants cleared2023: 5 descendants cleared2020: 3 descendants cleared2019: 1 descendant cleared2024: 3 descendants cleared2025: 1 descendant cleared20052010201520202025
  1. This deviceK073278 Spinous Process Plate SystemNuvasive, Inc. · 2008
  2. Descendant · cites it directly · 32 of its ownK102195 SP-Fix Spinous Process Fixation PlateGlobus Medical, Inc. · 2011
  3. Descendant · cites it directly · 30 of its ownK131238 Affix Spinous Process Plate SystemNuvasive, Inc. · 2013
  4. Descendant · cites it directly · 20 of its ownK132411 Affix II Spinous Process Plate SystemNu Vasive, Incorporated · 2013
  5. Descendant · cites it directly · 18 of its ownK133052 Affix (R) Next Gen Spinous Process Plate SystemNuvasive, Inc. · 2013
  6. Descendant · cites it directly · 18 of its ownK122509 Vertiflex Spinous Process Fixation PlateVertiflex, Inc. · 2012

Showing 5 of 58 descendants. See all descendants

Descendants cleared per year

2010: 22011: 32012: 32013: 92014: 72015: 52016: 42017: 22018: 32019: 12020: 32021: 32022: 42023: 52024: 32025: 1
2010high 9 (2013) · low 0 (2026)2026

Most influential descendants

Showing 5 of 58 · See all
  • K102195SP-Fix Spinous Process Fixation PlateGlobus Medical, Inc. · 2011 · cites it directly32descendants
  • K131238Affix Spinous Process Plate SystemNuvasive, Inc. · 2013 · cites it directly30descendants
  • K132411Affix II Spinous Process Plate SystemNu Vasive, Incorporated · 2013 · cites it directly20descendants
  • K133052Affix (R) Next Gen Spinous Process Plate SystemNuvasive, Inc. · 2013 · cites it directly18descendants
  • K122509Vertiflex Spinous Process Fixation PlateVertiflex, Inc. · 2012 · cites it directly18descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K073278Spinous Process Plate SystemNuvasive, Inc.2008—
+1K102195SP-Fix Spinous Process Fixation PlateGlobus Medical, Inc.2011—
+1K131238Affix Spinous Process Plate SystemNuvasive, Inc.2013—
+1K132411Affix II Spinous Process Plate SystemNu Vasive, Incorporated2013—
+1K133052Affix (R) Next Gen Spinous Process Plate SystemNuvasive, Inc.2013—
+1K122509Vertiflex Spinous Process Fixation PlateVertiflex, Inc.2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201020
201130
201230
201390
201470
201550
201640
201720
201830
201910
202030
202130
202240
202350
202430
202510
FIG. 1 — Lineage of K073278, 2008–2025Source: 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? (58)

See all 58

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

NumberDeviceApplicantDecidedDescendants
K102195SP-Fix Spinous Process Fixation PlateGlobus Medical, Inc.201132
K131238Affix Spinous Process Plate SystemNuvasive, Inc.201330
K132411Affix II Spinous Process Plate SystemNu Vasive, Incorporated201320
K133052Affix (R) Next Gen Spinous Process Plate SystemNuvasive, Inc.201318
K122509Vertiflex Spinous Process Fixation PlateVertiflex, Inc.201218
K133091Zip Mis Interspinous Fusion SystemAurora Spine201314
K103205Bridgepoint Spinous Process Camp- Posterior Fixation SystemAlphatec Spine, Inc.201114
K102020Vega Span Spinous Process Plate SystemSpinefrontier, Inc.20108
K133363Interbridge Interspinous Posterior Fixation SystemLdr Spine USA, Inc.20145
K093438Paradigm Interspinous Fusion PlateParadigm Spine, LLC20105

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, K102195 (Globus Medical, Inc., 2011) has gone furthest, with 32 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. 2008, 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 NuVasive® Spinous Process Plate System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (Ti - SI). It is intended for plate fixation/attachment to spinous process 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. It is not intended for stand-alone use.

Indications for use as stated in the FDA summary.

More from Nuvasive, Inc.

117 FDA decisions under this applicant name. See the company

  • P200022/S016Simplify® Cervical Artificial DiscNuvasive, Inc. · 2025
  • P200022/S017Simplify® Cervical Artificial DiscNuvasive, Inc. · 2025
  • P200022/S012Simplify DiscNuvasive, Inc. · 2025
  • P200022/S015Simplify Cervical Artificial DiscNuvasive, Inc. · 2025
  • P200022/S014Simplify Cervical Artificial DiscNuvasive, Inc. · 2024

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/K073278 · printed Nov 5, 2026

Cite this page

510(k) Report. “K073278: Spinous Process Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K073278

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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