510(k) Report

510(k) · Cleared

Cleared

Modified Vertiflex Spinal Screw System

K073143510(k) TraditionalCleared Apr 7, 2008152-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

Vertiflex, Inc. · MNI Orthosis, Spinal Pedicle Fixation

Cleared on Apr 7, 2008 as substantially equivalent to K062670 (Vertiflex (Tm), Incorporated, 2007) and 7 other predicates after a 152-day review. Its family tree reaches back 9 generations to 1990.

Decided
Apr 7, 2008
Review
152 days
Class
Class II
Product code
MNI
Recalls
None
Predicates
8

Its longest line of descent runs back 9 generations to K901587 (1990). 119 ancestors in all, the oldest K841189 (1984). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2007: 2 other ancestors2006: 6 other ancestors2005: 8 other ancestors2004: 15 other ancestors1999: 6 other ancestors2003: 10 other ancestors2002: 8 other ancestors2000: 11 other ancestors1998: 8 other ancestors1995: 6 other ancestors2001: 7 other ancestors1996: 7 other ancestors1993: 2 other ancestors1992: 5 other ancestors1990: 1 other ancestor1997: 4 other ancestors1994: 3 other ancestors1984: 1 other ancestorK901587 · 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) K993503 · Haider-Ucr Spinal System · International Advanced Medical Enterprises, Inc. · 2000K021623 · Ucr Spinal System, 5.5MM, 8.0MM Screws & Instruments · Iame, Inc. · 2002K032739 · Ucr Spinal System · Seaspine · 2003K043232 · Ucr Spinal System · Seaspine · 2004 · recalledK062670 · Vertiflex Spinal Screw System · Vertiflex (Tm), Incorporated · 20071980198519901995200020052010
Other ancestors, by generation 1 generation back: 7 other ancestors2 generations back: 20 other ancestors3 generations back: 44 other ancestors4 generations back: 30 other ancestors5 generations back: 8 other ancestors6 generations back: 1 other ancestor K062670 · Vertiflex Spinal Screw System · Vertiflex (Tm), Incorporated · 2007K043232 · Ucr Spinal System · Seaspine · 2004 · recalledK032739 · Ucr Spinal System · Seaspine · 2003K021623 · Ucr Spinal System, 5.5MM, 8.0MM Screws & Instruments · Iame, Inc. · 2002K993503 · Haider-Ucr Spinal System · International Advanced Medical Enterprises, Inc. · 2000K974749 · 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. · 1990−50
  1. Root · 9 generations backK901587 TSRH Sacral L-ConnectorDanek Medical, Inc. · 1990
  2. 5 generations between
  3. 3 generations backK032739 Ucr Spinal SystemSeaspine · 2003
  4. 2 generations backK043232 Ucr Spinal SystemSeaspine · 2004 · Recalled
  5. 1 generation backK062670 Vertiflex Spinal Screw SystemVertiflex (Tm), Incorporated · 2007
  6. This deviceK073143 Modified Vertiflex Spinal Screw SystemVertiflex, Inc. · 2008
Show all 9 generations
  1. Root · 9 generations backK901587 TSRH Sacral L-ConnectorDanek Medical, Inc. · 1990
  2. 8 generations backK950099 Synergy (TM) TI Posterior Spinal SystemBuckman Co., Inc. · 1997
  3. 7 generations backK973836 Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the…Cross Medical Products, Inc. · 1998
  4. 6 generations backK974749 Synergy Closed Variable Locking Screw (VLS), Part of the Cross…Cross Medical Products, Inc. · 1998
  5. 5 generations backK993503 Haider-Ucr Spinal SystemInternational Advanced Medical Enterprises, Inc. · 2000
  6. 4 generations backK021623 Ucr Spinal System, 5.5MM, 8.0MM Screws & InstrumentsIame, Inc. · 2002
  7. 3 generations backK032739 Ucr Spinal SystemSeaspine · 2003
  8. 2 generations backK043232 Ucr Spinal SystemSeaspine · 2004 · Recalled
  9. 1 generation backK062670 Vertiflex Spinal Screw SystemVertiflex (Tm), Incorporated · 2007
  10. This deviceK073143 Modified Vertiflex Spinal Screw SystemVertiflex, Inc. · 2008
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−9K901587TSRH Sacral L-ConnectorDanek Medical, Inc.1990—
−8K950099Synergy (TM) TI Posterior Spinal SystemBuckman Co., Inc.1997—
−7K973836Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross…Cross Medical Products, Inc.1998—
−6K974749Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy…Cross Medical Products, Inc.1998—
−5K993503Haider-Ucr Spinal SystemInternational Advanced Medical Enterprises, Inc.2000—
−4K021623Ucr Spinal System, 5.5MM, 8.0MM Screws & InstrumentsIame, Inc.2002—
−3K032739Ucr Spinal SystemSeaspine2003—
−2K043232Ucr Spinal SystemSeaspine20041
−1K062670Vertiflex Spinal Screw SystemVertiflex (Tm), Incorporated2007—
0 (this device)K073143Modified Vertiflex Spinal Screw SystemVertiflex, Inc.2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
199010
199250
199320
199430
199560
199670
199740
199880
199960
2000110
200170
200280
2003100
2004150
200580
200660
200720
FIG. 1 — Lineage of K073143, 1990–2008Source: 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? (8)

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
*K062670Vertiflex Spinal Screw System
Summary page 1
…s substantially equivalent, in whole or in part, to the following commercially available predicate device: VertiFlex®Spinal Screw System - (VertiFlex®, Inc.; K062670) Isobar®TTL System - (Scient'x; K991326, et seq) DynesysTM System - (Zimmer Spine; K031511, et seq) N Fix II (N…
Vertiflex (Tm), Incorporated2007—
*K991326Isobar Semi-Rigid Spinal System
Summary page 1
…t, to the following commercially available predicate device: VertiFlex®Spinal Screw System - (VertiFlex®, Inc.; K062670) Isobar®TTL System - (Scient'x; K991326, et seq) DynesysTM System - (Zimmer Spine; K031511, et seq) N Fix II (N Flex) System - (N Spine; K061774) CD HO…
Scien'Tx USA, Inc.1999—
*K031511Dynesys Spinal System
Summary page 1
…e device: VertiFlex®Spinal Screw System - (VertiFlex®, Inc.; K062670) Isobar®TTL System - (Scient'x; K991326, et seq) DynesysTM System - (Zimmer Spine; K031511, et seq) N Fix II (N Flex) System - (N Spine; K061774) CD HORIZON® System - (Medtronic; K063670 & K060615) Accu…
Centerpulse Spine-Tech, Inc.20044
*K061774Nfix II Pedicle Screw System
Summary page 1
…Inc.; K062670) Isobar®TTL System - (Scient'x; K991326, et seq) DynesysTM System - (Zimmer Spine; K031511, et seq) N Fix II (N Flex) System - (N Spine; K061774) CD HORIZON® System - (Medtronic; K063670 & K060615) AccuFlexT M (ProtexTM) System - (Globus Medical; K0520690…
N Spine, Inc.20067
*K063670Modifications to CD Horizon Spinal System
Summary page 1
…t'x; K991326, et seq) DynesysTM System - (Zimmer Spine; K031511, et seq) N Fix II (N Flex) System - (N Spine; K061774) CD HORIZON® System - (Medtronic; K063670 & K060615) AccuFlexT M (ProtexTM) System - (Globus Medical; K0520690 ZODIA C®DYNAMOTM System - Alphatec; K07208 1) 5.…
Medtronic Sofamor Danek2007—
*K060615CD Horizon Spinal System
Summary page 1
…26, et seq) DynesysTM System - (Zimmer Spine; K031511, et seq) N Fix II (N Flex) System - (N Spine; K061774) CD HORIZON® System - (Medtronic; K063670 & K060615) AccuFlexT M (ProtexTM) System - (Globus Medical; K0520690 ZODIA C®DYNAMOTM System - Alphatec; K07208 1) 5.4 Device…
Medtronic Sofamor Danek200634
*K052069Protex Stabilization System with Additional Componentes
Summary page 1
…seq) N Fix II (N Flex) System - (N Spine; K061774) CD HORIZON® System - (Medtronic; K063670 & K060615) AccuFlexT M (ProtexTM) System - (Globus Medical; K0520690 ZODIA C®DYNAMOTM System - Alphatec; K07208 1) 5.4 Device Description The Modified VertiFlex®Spinal Screw System is…
Globus Medical, Inc.2005—
*K072081Zodiac Dynamo Semi-Rigid Spinal System
Summary page 1
…1774) CD HORIZON® System - (Medtronic; K063670 & K060615) AccuFlexT M (ProtexTM) System - (Globus Medical; K0520690 ZODIA C®DYNAMOTM System - Alphatec; K07208 1) 5.4 Device Description The Modified VertiFlex®Spinal Screw System is, like the predicate VertiFlex® Spinal Screw S…
Alphatec Spine, Inc.2007—

Also cleared against K062670: 2 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 18 years and passes through 8 companies; a new generation was cleared every 1.2 years on median.
  • 16 of the 119 ancestors have a recall of any class.
  • 2 other devices also cite its predicate K062670.

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. 2008, 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?

When used as a pedicle screw fixation system in skeletally mature patients, the Modified VertiFlex® Spinal Screw System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic, lumbar, and sacral spine: Degenerative spondylolisthesis with objective evidence of neurological impairment, kyphosis, and failed previous fusion…

Read the full statement (120 words)

When used as a pedicle screw fixation system in skeletally mature patients, the Modified VertiFlex® Spinal Screw System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic, lumbar, and sacral spine: Degenerative spondylolisthesis with objective evidence of neurological impairment, kyphosis, and failed previous fusion (pseudoarthrosis).

In addition, when used as a pedicle screw fixation system, the Modified VertiFlex® Spinal Screw System is indicated in patients who are receiving fusions with autogenous graft, who are having the device fixed or attached to the lumbar or sacral spine, and who are having the device removed after the development of a solid fusion mass.

Indications for use as stated in the FDA summary.

Also cleared against K062670

2 other devices cite the same predicate.

  • K102870Exactech Proliant Polyaxial Pedicle Screw SystemExactech, Inc. · 2011
  • K073245Extended Vertiflex Spinal Screw SystemVertiflex, Inc. · 2008

More from Vertiflex, Inc.

5 FDA decisions under this applicant name. See the company

  • K122509Vertiflex Spinous Process Fixation PlateVertiflex, Inc. · 2012
  • K122662Vertiflex Direct Decompression SystemVertiflex, Inc. · 2012
  • K082270Octane Vertebral Body Replacement (VBR) SystemVertiflex, Inc. · 2008
  • K073245Extended Vertiflex Spinal Screw SystemVertiflex, Inc. · 2008

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/K073143 · printed Nov 5, 2026

Cite this page

510(k) Report. “K073143: Modified Vertiflex Spinal Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K073143

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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