510(k) Report

510(k) · Cleared

Cleared

Aversion Pedicle Screw System

K133103510(k) TraditionalCleared Jan 27, 2014119-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

K7, LLC · MNI Orthosis, Spinal Pedicle Fixation

Cleared on Jan 27, 2014 as substantially equivalent to K031655 (Medtronic Sofamor Danek USA, Inc., 2003) and 6 other predicates after a 119-day review. Its family tree reaches back 7 generations to 1995.

Decided
Jan 27, 2014
Review
119 days
Class
Class II
Product code
MNI
Recalls
None
Predicates
7

Its longest line of descent runs back 7 generations to K950697 (1995). 57 ancestors in all, the oldest K901587 (1990). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2004: 7 other ancestors2003: 4 other ancestors2002: 2 other ancestors1999: 2 other ancestors1998: 3 other ancestors1997: 3 other ancestors2008: 2 other ancestors2007: 3 other ancestors2006: 2 other ancestors2001: 4 other ancestors2000: 2 other ancestors1996: 1 other ancestor1995: 2 other ancestors1994: 2 other ancestors1993: 2 other ancestors1992: 5 other ancestors1990: 2 other ancestors2005: 2 other ancestorsK950697 · Depuy Motech Moss Miami Spinal System - Pedicle Fixation · Depuy Motech · 1995×2: 2 generations cleared close together, K050461 (2005), K052761 (2005) ×2: 2 generations cleared close together, K060361 (2006), K060979 (2006) K082942 · Modfication to: Expedium Spine System · Depuy Spine, Inc. · 2008K090648 · Viper 2 System · Depuy Spine, Inc. · 2009199019952000200520102015
Other ancestors, by generation 1 generation back: 6 other ancestors2 generations back: 26 other ancestors3 generations back: 7 other ancestors4 generations back: 6 other ancestors5 generations back: 1 other ancestor6 generations back: 3 other ancestors7 generations back: 1 other ancestor K090648 · Viper 2 System · Depuy Spine, Inc. · 2009K082942 · Modfication to: Expedium Spine System · Depuy Spine, Inc. · 2008K060979 · Xia Titanium and 4.5 Spinal Systems · Stryker Spine · 2006K060361 · Xia Spinal System, Xia 4.5 Spinal System · Stryker Spine · 2006 · recalledK052761 · Modification to: Xia 4.5 Spinal System · Stryker Spine · 2005K050461 · Xia 4.5 Spinal System · Stryker Spine · 2005K950697 · Depuy Motech Moss Miami Spinal System - Pedicle Fixation · Depuy Motech · 1995−50
  1. Root · 7 generations backK950697 Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech · 1995
  2. 6 generations backK050461 Xia 4.5 Spinal SystemStryker Spine · 2005
  3. 5 generations backK052761 Modification to: Xia 4.5 Spinal SystemStryker Spine · 2005
  4. 4 generations backK060361 Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine · 2006 · Recalled
  5. 3 generations backK060979 Xia Titanium and 4.5 Spinal SystemsStryker Spine · 2006
  6. 2 generations backK082942 Modfication to: Expedium Spine SystemDepuy Spine, Inc. · 2008
  7. 1 generation backK090648 Viper 2 SystemDepuy Spine, Inc. · 2009
  8. This deviceK133103 Aversion Pedicle Screw SystemK7, LLC · 2014
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K950697Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech1995—
−6K050461Xia 4.5 Spinal SystemStryker Spine2005—
−5K052761Modification to: Xia 4.5 Spinal SystemStryker Spine2005—
−4K060361Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine20061
−3K060979Xia Titanium and 4.5 Spinal SystemsStryker Spine2006—
−2K082942Modfication to: Expedium Spine SystemDepuy Spine, Inc.2008—
−1K090648Viper 2 SystemDepuy Spine, Inc.2009—
0 (this device)K133103Aversion Pedicle Screw SystemK7, LLC2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199020
199250
199320
199420
199520
199610
199730
199830
199920
200020
200140
200220
200340
200470
200520
200620
200730
200820
FIG. 1 — Lineage of K133103, 1995–2014Source: 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.

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  • 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? (7)

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
…he Aversion Pedicle Screw System is manufactured from titanium alloy (Ti-6AI-4V ELI) as described by ASTM F1 36. Predicate Devices: CD HORIZON® (K031 655/K041 460) Moss@ Miami (K992168/K022623) Synergy TM VLS (K950099/K974749)…
Medtronic Sofamor Danek USA, Inc.20031
*K041460CD Horizon Spinal System
Summary page 1
…on Pedicle Screw System is manufactured from titanium alloy (Ti-6AI-4V ELI) as described by ASTM F1 36. Predicate Devices: CD HORIZON® (K031 655/K041 460) Moss@ Miami (K992168/K022623) Synergy TM VLS (K950099/K974749)…
Medtronic Sofamor Danek USA, Inc.2004—
*K992168Moss Miami 6.35MM Polyaxial Screw
Summary page 1
…titanium alloy (Ti-6AI-4V ELI) as described by ASTM F1 36. Predicate Devices: CD HORIZON® (K031 655/K041 460) Moss@ Miami (K992168/K022623) Synergy TM VLS (K950099/K974749) Viper Tm2 (K090648) Performance Data:…
Depuyacromed1999—
*K0226235.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System)
Summary page 1
…alloy (Ti-6AI-4V ELI) as described by ASTM F1 36. Predicate Devices: CD HORIZON® (K031 655/K041 460) Moss@ Miami (K992168/K022623) Synergy TM VLS (K950099/K974749) Viper Tm2 (K090648) Performance Data: St…
Depuyacromed2002—
*K950099Synergy (TM) TI Posterior Spinal System
Summary page 1
…scribed by ASTM F1 36. Predicate Devices: CD HORIZON® (K031 655/K041 460) Moss@ Miami (K992168/K022623) Synergy TM VLS (K950099/K974749) Viper Tm2 (K090648) Performance Data: Static compression bending and torsion, and dynamic…
Buckman Co., Inc.1997—
*K974749Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy Anterior…
Summary page 1
…by ASTM F1 36. Predicate Devices: CD HORIZON® (K031 655/K041 460) Moss@ Miami (K992168/K022623) Synergy TM VLS (K950099/K974749) Viper Tm2 (K090648) Performance Data: Static compression bending and torsion, and dynamic compress…
Cross Medical Products, Inc.1998—
*K090648Viper 2 System
Summary page 1
…ZON® (K031 655/K041 460) Moss@ Miami (K992168/K022623) Synergy TM VLS (K950099/K974749) Viper Tm2 (K090648) Performance Data: Static compression bending and torsion, and dynamic compression bending tests we…
Depuy Spine, Inc.2009—

Also cleared against K031655: 24 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 19 years and passes through 4 companies; a new generation was cleared every 7 months on median.
  • 2 of the 57 ancestors have a recall of any class.
  • 24 other devices also cite its predicate K031655.

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. 2014, 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 Aversion Pedicle Screw System is intended far posterior, noncervical (Ti-Si) pedicle fixation to provide immobilization and stabilization in skeletally mature patients as an adjunct to fusion for 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 LS-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, spinal stenosis, scoliosis, kyphosis, lardosis, spinal tumor, pseudarthrosis and failed previous fusion

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
  • K130958True Spinal Fixation SystemInnovative Surgical Designs · 2013

More from K7, LLC

3 FDA decisions under this applicant name. See the company

  • K133126K7 Lumbar SpacersK7, LLC · 2013
  • K123388K7C SpacerK7, LLC · 2013

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/K133103 · printed Nov 6, 2026

Cite this page

510(k) Report. “K133103: Aversion 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/K133103

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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