510(k) Report

510(k) · Cleared

Cleared

Inertia Pedicle Screw System

K101278510(k) SpecialCleared Dec 20, 2010228-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 · MNH Orthosis, Spondylolisthesis Spinal Fixation

Cleared on Dec 20, 2010 as substantially equivalent to K031655 (Medtronic Sofamor Danek USA, Inc., 2003) and 8 other predicates after a 228-day review. Its family tree reaches back 4 generations to 1990. 111 later devices descend from it.

Decided
Dec 20, 2010
Review
228 days
Class
Class II
Product code
MNH
Recalls
None
Predicates
9

Its longest line of descent runs back 4 generations to K901587 (1990). 32 ancestors in all. 111 later devices descend from it, 7 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2005: 1 other ancestor2004: 1 other ancestor2003: 3 other ancestors2002: 2 other ancestors1999: 1 other ancestor2001: 1 other ancestor2000: 4 other ancestors1998: 1 other ancestor1997: 1 other ancestor1996: 1 other ancestor1995: 2 other ancestors1994: 2 other ancestors1993: 2 other ancestors1992: 5 other ancestors1990: 1 other ancestor2022: 13 descendants cleared2018: 3 descendants cleared2023: 14 descendants cleared2013: 1 descendant cleared2014: 1 descendant cleared2019: 4 descendants cleared2016: 1 descendant cleared2020: 10 descendants cleared2024: 17 descendants cleared2021: 6 descendants cleared2025: 21 descendants cleared2026: 20 descendants clearedK901587 · TSRH Sacral L-Connector · Danek Medical, Inc. · 1990K950099 · Synergy (TM) TI Posterior Spinal System · Buckman Co., Inc. · 1997×2: 2 generations cleared close together, K973836 (1998), K974749 (1998) 1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 7 other ancestors2 generations back: 20 other ancestors3 generations back: 1 other ancestor 1 generation forward: 7 descendants2 generations forward: 4 descendants3 generations forward: 7 descendants4 generations forward: 22 descendants5 generations forward: 28 descendants6 generations forward: 24 descendants7 generations forward: 14 descendants8 generations forward: 4 descendants9 generations forward: 1 descendant K974749 · Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy Anterior and Posterior Spinal Systems · Cross Medical Products, Inc. · 1998K973836 · Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross Medical-Synergy Anterior Spinal System · Cross Medical Products, Inc. · 1998K950099 · Synergy (TM) TI Posterior Spinal System · Buckman Co., Inc. · 1997K901587 · TSRH Sacral L-Connector · Danek Medical, Inc. · 19900+5
  1. Root · 4 generations backK901587 TSRH Sacral L-ConnectorDanek Medical, Inc. · 1990
  2. 3 generations backK950099 Synergy (TM) TI Posterior Spinal SystemBuckman Co., Inc. · 1997
  3. 2 generations backK973836 Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the…Cross Medical Products, Inc. · 1998
  4. 1 generation backK974749 Synergy Closed Variable Locking Screw (VLS), Part of the Cross…Cross Medical Products, Inc. · 1998
  5. This deviceK101278 Inertia Pedicle Screw SystemNexxt Spine, LLC · 2010
  6. Descendant · cites it directly · 107 of its ownK132412 Inertia Mis Pedicle Screw SystemNexxt Spine, LLC · 2013
  7. Descendant · cites it directly · 106 of its ownK141376 Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx…Nexxt Spine, LLC · 2014
  8. Descendant · 2 generations on · 100 of its ownK181435 ATEC Cervical Spacer SystemAlphatec Spine, Inc. · 2018
  9. Descendant · 3 generations on · 99 of its ownK183705 IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc. · 2019
  10. Descendant · 4 generations on · 78 of its ownK191311 ATEC Lateral Interbody SystemAlphatec Spine, Inc. · 2019

Showing 5 of 111 descendants. See all descendants

Descendants cleared per year

2013: 12014: 12016: 12018: 32019: 42020: 102021: 62022: 132023: 142024: 172025: 212026: 20
2013high 21 (2025) · low 0 (2015)2026

Most influential descendants

Showing 5 of 111 · 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
−4K901587TSRH Sacral L-ConnectorDanek Medical, Inc.1990—
−3K950099Synergy (TM) TI Posterior Spinal SystemBuckman Co., Inc.1997—
−2K973836Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross…Cross Medical Products, Inc.1998—
−1K974749Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy…Cross Medical Products, Inc.1998—
0 (this device)K101278Inertia Pedicle Screw SystemNexxt Spine, LLC2010—
+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—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199250
199320
199420
199520
199610
199710
199810
199910
200040
200110
200220
200330
200410
200510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201410
201610
201830
201940
2020100
202160
2022130
2023140
2024170
2025210
2026200
FIG. 1 — Lineage of K101278, 1990–2026Source: 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 MNH? 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
*K031655CD Horizon Spinal System
Summary page 1
…Pedicle Screw System components are manufactured from titanium alloy (1i-6Ai-4V) as described by ASTM F136. Predicate Devices: CP HORIZONID (K031655, K041460) Moss Miami (K992168, K022623) Synergy VLS (K950099, K974749)…
Medtronic Sofamor Danek USA, Inc.20031
*K041460CD Horizon Spinal System
Summary page 1
…crew System components are manufactured from titanium alloy (1i-6Ai-4V) as described by ASTM F136. Predicate Devices: CP HORIZONID (K031655, K041460) Moss Miami (K992168, K022623) Synergy VLS (K950099, K974749)…
Medtronic Sofamor Danek USA, Inc.2004—
*K992168Moss Miami 6.35MM Polyaxial Screw
Summary page 1
…from titanium alloy (1i-6Ai-4V) as described by ASTM F136. Predicate Devices: CP HORIZONID (K031655, K041460) Moss Miami (K992168, K022623) Synergy VLS (K950099, K974749) Optima"' Spinal System (K024096, K031585…
Depuyacromed1999—
*K0226235.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System)
Summary page 1
…from titanium alloy (1i-6Ai-4V) as described by ASTM F136. Predicate Devices: CP HORIZONID (K031655, K041460) Moss Miami (K992168, K022623) Synergy VLS (K950099, K974749) Optima"' Spinal System (K024096, K031585, K051971…
Depuyacromed2002—
*K950099Synergy (TM) TI Posterior Spinal System
Summary page 1
…escribed by ASTM F136. Predicate Devices: CP HORIZONID (K031655, K041460) Moss Miami (K992168, K022623) Synergy VLS (K950099, K974749) Optima"' Spinal System (K024096, K031585, K051971)…
Buckman Co., Inc.1997—
*K974749Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy Anterior…
Summary page 1
…by ASTM F136. Predicate Devices: CP HORIZONID (K031655, K041460) Moss Miami (K992168, K022623) Synergy VLS (K950099, K974749) Optima"' Spinal System (K024096, K031585, K051971)…
Cross Medical Products, Inc.1998—
*K024096Optima, Spinal System
Summary page 1
…55, K041460) Moss Miami (K992168, K022623) Synergy VLS (K950099, K974749) Optima"' Spinal System (K024096, K031585, K051971) Page 14…
U&I Corp., America20033
*K031585U&I, Optima, Spinal System
Summary page 1
…60) Moss Miami (K992168, K022623) Synergy VLS (K950099, K974749) Optima"' Spinal System (K024096, K031585, K051971) Page 14…
U&I Corp., America20035
*K051971Optima Spinal System
Summary page 1
…Moss Miami (K992168, K022623) Synergy VLS (K950099, K974749) Optima"' Spinal System (K024096, K031585, K051971) Page 14…
U&I Corp.2005—

Also cleared against K031655: 24 other devices →

What descends from it? (111)

See all 111

7 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
K180458FOCUS Pedicle Screw SystemNvision Biomedical Technologies, LLC20181
K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230
K180324Patriot Spinal Fixation SystemValorus Spine20180

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 20 years and passes through 4 companies; a new generation was cleared every 6.2 years on median.
  • 4 of the 32 ancestors have a recall of any class.
  • Of its descendants, K132412 (Nexxt Spine, LLC, 2013) has gone furthest, with 107 descendants of its own.
  • 24 other devices also cite its predicate K031655.

How does its category compare?

All MNH devices

MNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · MNH

8in 2016

2007: 52008: 132009: 132010: 102011: 172012: 72013: 102014: 122015: 102016: 8
2007high 17 (2011) · low 0 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MNH

93in 2016

2007: 123 days median2008: 65 days median2009: 151 days median2010: 106 days median2011: 171 days median2012: 93 days median2013: 124 days median2014: 140 days median2015: 99 days median2016: 93 days median
2007high 171 (2011) · low 65 (2008)2026

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

Recalls per year · MNH

1in 2016

2009: 72012: 12013: 12016: 1
2007high 7 (2009) · low 0 (2007)2026

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

Adverse event reports per year · MNH

89in 2025

2007: 182008: 302009: 452010: 592011: 1072012: 4332013: 4642014: 2862015: 1522016: 2162017: 1742018: 1292019: 4032020: 4322021: 5312022: 2652023: 1212024: 3022025: 89
2007high 531 (2021) · low 18 (2007)2025

MAUDE reports naming product code MNH, 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
20075123018
20081365030
200913151745
201010106059
2011171710107
20127931433
2013101241464
2014121400286
201510990152
20168931216
20170—0174
20180—0129
20190—0403
20200—0432
20210—0531
20220—0265
20230—0121
20240—0302
20250—089
20260—0—

What is it indicated for?

The Inertia Pedicle Screw System is intended to provide immobilization 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 (TI to S2): severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; spinal stenosis; scoiosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

Indications for use as stated in the FDA summary.

Also cleared against K031655

24 other devices cite the same predicate.

  • K241663Eminent Spine 3D Titanium Pedicle Screw SystemEminent Spine · 2025
  • K143200MIS Z-Pedicle Screw SystemZ-Medical GmbH & Co. KG · 2015
  • K142591CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014
  • K133402K2M Modular HooksK2m, Inc. · 2014
  • K133690True Spinal Fussion SystemInnovative Surgical Designs · 2014
  • K133103Aversion Pedicle Screw SystemK7, LLC · 2014

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 MNH

The MNH category page

  • K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2016
  • K162801CastleLoc Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2016
  • K162143FixxSure® X-LinkInnovasis, Inc. · 2016
  • K161151Spinal fixation systemCanwell Medical Co., Ltd. · 2016
  • K162189ANAX™ 5.5 Spinal SystemU&I Corporation · 2016

https://510kreport.com/device/K101278 · printed Nov 6, 2026

Cite this page

510(k) Report. “K101278: 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/K101278

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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