510(k) Report

510(k) · Cleared

Cleared

Inertia Pedicle Screw System

K090984510(k) TraditionalCleared Jun 30, 200984-day reviewClass II21 CFR 888.3070

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

Nexxt Spine, LLC · MNI Orthosis, Spinal Pedicle Fixation

Cleared on Jun 30, 2009 after an 84-day review. The FDA summary names no predicate by number. 108 later devices descend from it.

Decided
Jun 30, 2009
Review
84 days
Class
Class II
Product code
MNI
Recalls
None
Predicates
0

108 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2022: 13 descendants cleared2023: 14 descendants cleared2013: 1 descendant cleared2014: 1 descendant cleared2019: 4 descendants cleared2016: 1 descendant cleared2018: 1 descendant cleared2024: 17 descendants cleared2021: 6 descendants cleared2025: 21 descendants cleared2020: 9 descendants cleared2026: 20 descendants cleared20052010201520202025
  1. This deviceK090984 Inertia Pedicle Screw SystemNexxt Spine, LLC · 2009
  2. Descendant · cites it directly · 107 of its ownK132412 Inertia Mis Pedicle Screw SystemNexxt Spine, LLC · 2013
  3. Descendant · cites it directly · 106 of its ownK141376 Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx…Nexxt Spine, LLC · 2014
  4. Descendant · 2 generations on · 100 of its ownK181435 ATEC Cervical Spacer SystemAlphatec Spine, Inc. · 2018
  5. Descendant · 3 generations on · 99 of its ownK183705 IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc. · 2019
  6. Descendant · 4 generations on · 78 of its ownK191311 ATEC Lateral Interbody SystemAlphatec Spine, Inc. · 2019

Showing 5 of 108 descendants. See all descendants

Descendants cleared per year

2013: 12014: 12016: 12018: 12019: 42020: 92021: 62022: 132023: 142024: 172025: 212026: 20
2013high 21 (2025) · low 0 (2015)2026

Most influential descendants

Showing 5 of 108 · See all
  • K132412Inertia Mis Pedicle Screw SystemNexxt Spine, LLC · 2013 · cites it directly107descendants
  • K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC · 2014 · cites it directly106descendants
  • K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc. · 2018 · 2 generations on100descendants
  • K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc. · 2019 · 3 generations on99descendants
  • K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc. · 2019 · 4 generations on78descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K090984Inertia Pedicle Screw SystemNexxt Spine, LLC2009—
+1K132412Inertia Mis Pedicle Screw SystemNexxt Spine, LLC2013—
+1K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure…Nexxt Spine, LLC2014—
+2K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018—
+3K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.2019—
+4K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.2019—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201410
201610
201810
201940
202090
202160
2022130
2023140
2024170
2025210
2026200
FIG. 1 — Lineage of K090984, 2009–2026Source: 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 MNI? 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?

The FDA summary names no predicate by number.

What descends from it? (108)

See all 108

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

NumberDeviceApplicantDecidedDescendants
K132412Inertia Mis Pedicle Screw SystemNexxt Spine, LLC2013107
K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC2014106
K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913
K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221
K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230

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, K132412 (Nexxt Spine, LLC, 2013) has gone furthest, with 107 descendants of its own.

How does its category compare?

All MNI devices

MNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · MNI

1in 2017

2007: 202008: 232009: 182010: 162011: 172012: 192013: 142014: 62015: 122016: 72017: 1
2007high 23 (2008) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MNI

168in 2016

2007: 82 days median2008: 64 days median2009: 86 days median2010: 74 days median2011: 111 days median2012: 75 days median2013: 77 days median2014: 104 days median2015: 54 days median2016: 168 days median
2007high 168 (2016) · low 54 (2015)2026

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

Recalls per year · MNI

1in 2018

2007: 262008: 82009: 32010: 12012: 12013: 42015: 12018: 1
2007high 26 (2007) · low 0 (2011)2026

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

Adverse event reports per year · MNI

80in 2025

2007: 832008: 1082009: 1382010: 1262011: 1462012: 2002013: 8242014: 3012015: 2602016: 1172017: 2472018: 1342019: 1882020: 1152021: 2702022: 2142023: 1222024: 1142025: 80
2007high 824 (2013) · low 80 (2025)2025

MAUDE reports naming product code MNI, 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
200720822683
200823648108
200918863138
201016741126
2011171110146
201219751200
201314774824
201461040301
201512541260
201671680117
20171—0247
20180—1134
20190—0188
20200—0115
20210—0270
20220—0214
20230—0122
20240—0114
20250—080
20260—0—

What is it indicated for?

The InertiaTM Pedicle Screw System is intended to provide ilmnobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S I vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

Indications for use as stated in the FDA summary.

More from Nexxt Spine, LLC

22 FDA decisions under this applicant name. See the company

  • K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC · 2023
  • K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC · 2022
  • K220291NEXXT SPINE NAVIGATION SystemNexxt Spine, LLC · 2022
  • K202230NEXXT MATRIXX Stand Alone ALIF SystemNexxt Spine, LLC · 2020
  • K202192STRUXXURE®-L and STRUXXURE®-A Plate SystemNexxt Spine, LLC · 2020

Recent decisions in MNI

The MNI category page

  • K171497Mikron Spinal Fixation SystemMikron Makina Sanayi Ticaret Co., Ltd. · 2017
  • K160731LumFix Spinal Fixation SytemCG Bio Co., Ltd. · 2016
  • K151458Double Medical Universal Spine SystemDouble Medical Technology, Inc. · 2016
  • K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A. · 2016
  • K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A. · 2016

https://510kreport.com/device/K090984 · printed Nov 6, 2026

Cite this page

510(k) Report. “K090984: Inertia Pedicle Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090984

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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