510(k) · Cleared
ClearedVertiflex Spinal Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vertiflex (Tm), Incorporated · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Jan 12, 2007 as substantially equivalent to K043232 (Seaspine, 2004) and 6 other predicates after a 127-day review. Its family tree reaches back 8 generations to 1990. 12 later devices descend from it.
- Decided
- Jan 12, 2007
- Review
- 127 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 8 generations to K901587 (1990). 54 ancestors in all. 12 later devices descend from it, 3 citing it directly.
- Root · 8 generations backK901587 TSRH Sacral L-ConnectorDanek Medical, Inc. · 1990
- 7 generations backK950099 Synergy (TM) TI Posterior Spinal SystemBuckman Co., Inc. · 1997
- 6 generations backK973836 Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the…Cross Medical Products, Inc. · 1998
- 5 generations backK974749 Synergy Closed Variable Locking Screw (VLS), Part of the Cross…Cross Medical Products, Inc. · 1998
- 4 generations backK993503 Haider-Ucr Spinal SystemInternational Advanced Medical Enterprises, Inc. · 2000
- 3 generations backK021623 Ucr Spinal System, 5.5MM, 8.0MM Screws & InstrumentsIame, Inc. · 2002
- 2 generations backK032739 Ucr Spinal SystemSeaspine · 2003
- 1 generation backK043232 Ucr Spinal SystemSeaspine · 2004 · Recalled
- This deviceK062670 Vertiflex Spinal Screw SystemVertiflex (Tm), Incorporated · 2007
- Descendant · cites it directly · 10 of its ownK073245 Extended Vertiflex Spinal Screw SystemVertiflex, Inc. · 2008
- Descendant · cites it directly · 9 of its ownK102870 Exactech Proliant Polyaxial Pedicle Screw SystemExactech, Inc. · 2011
- Descendant · 2 generations on · 4 of its ownK151704 Diplomat® Spinal SystemSignus Medizintechnik GmbH · 2016
- Descendant · 3 generations on · 2 of its ownK191932 Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA · 2019
- Descendant · 4 generations on · 1 of its ownK231809 Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone…Ulrich Medical USA · 2023
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K073245Extended Vertiflex Spinal Screw SystemVertiflex, Inc. · 2008 · cites it directly10descendants
- K102870Exactech Proliant Polyaxial Pedicle Screw SystemExactech, Inc. · 2011 · cites it directly9descendants
- K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH · 2016 · 2 generations on4descendants
- K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA · 2019 · 3 generations on2descendants
- K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA · 2023 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K901587 | TSRH Sacral L-Connector | Danek Medical, Inc. | 1990 | — |
| −7 | K950099 | Synergy (TM) TI Posterior Spinal System | Buckman Co., Inc. | 1997 | — |
| −6 | K973836 | Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross… | Cross Medical Products, Inc. | 1998 | — |
| −5 | K974749 | Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy… | Cross Medical Products, Inc. | 1998 | — |
| −4 | K993503 | Haider-Ucr Spinal System | International Advanced Medical Enterprises, Inc. | 2000 | — |
| −3 | K021623 | Ucr Spinal System, 5.5MM, 8.0MM Screws & Instruments | Iame, Inc. | 2002 | — |
| −2 | K032739 | Ucr Spinal System | Seaspine | 2003 | — |
| −1 | K043232 | Ucr Spinal System | Seaspine | 2004 | 1 |
| 0 (this device) | K062670 | Vertiflex Spinal Screw System | Vertiflex (Tm), Incorporated | 2007 | — |
| +1 | K073245 | Extended Vertiflex Spinal Screw System | Vertiflex, Inc. | 2008 | — |
| +1 | K102870 | Exactech Proliant Polyaxial Pedicle Screw System | Exactech, Inc. | 2011 | — |
| +2 | K151704 | Diplomat® Spinal System | Signus Medizintechnik GmbH | 2016 | — |
| +3 | K191932 | Momentum™ Posterior Spinal Fixation System | Ulrich Medical USA | 2019 | — |
| +4 | K231809 | Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement… | Ulrich Medical USA | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 5 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 4 | 0 |
| 2003 | 7 | 0 |
| 2004 | 7 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
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
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K043232 | Ucr Spinal SystemSummary page 1…The subject device is substantially equivalent, in whole or in part, to the following commercially available predicate devices: UCR Spinal System (Seaspine; K043232) VIPER TM Spine System (DePuy; K061520) XiaR Spinal System (Stryker; K060979) Click'X®R)System (Synthes; K03117… | 2004 |
| * | K061520 | Viper Spine SystemSummary page 1…nt, in whole or in part, to the following commercially available predicate devices: UCR Spinal System (Seaspine; K043232) VIPER TM Spine System (DePuy; K061520) XiaR Spinal System (Stryker; K060979) Click'X®R)System (Synthes; K031175) ST36OTM Spinal Fixation System (Zimm… | 2006 |
| * | K060979 | Xia Titanium and 4.5 Spinal SystemsSummary page 1…commercially available predicate devices: UCR Spinal System (Seaspine; K043232) VIPER TM Spine System (DePuy; K061520) XiaR Spinal System (Stryker; K060979) Click'X®R)System (Synthes; K031175) ST36OTM Spinal Fixation System (Zimmer; K041925) CD HORIZON®Spinal System… | 2006 |
| * | K031175 | Click'x Monoaxial Screws and HooksSummary page 1…es: UCR Spinal System (Seaspine; K043232) VIPER TM Spine System (DePuy; K061520) XiaR Spinal System (Stryker; K060979) Click'X®R)System (Synthes; K031175) ST36OTM Spinal Fixation System (Zimmer; K041925) CD HORIZON®Spinal System (Medtronic Sofamor Danek; K043343) P… | 2003 |
| * | K041925 | ST360 Spinal Fixation SystemSummary page 1…IPER TM Spine System (DePuy; K061520) XiaR Spinal System (Stryker; K060979) Click'X®R)System (Synthes; K031175) ST36OTM Spinal Fixation System (Zimmer; K041925) CD HORIZON®Spinal System (Medtronic Sofamor Danek; K043343) PathFinderTMSpinal System (Spinal Concepts; K030625) 5.4… | 2004 |
| * | K043343 | Modification to: CD Horizon Spinal SystemSummary page 1…ryker; K060979) Click'X®R)System (Synthes; K031175) ST36OTM Spinal Fixation System (Zimmer; K041925) CD HORIZON®Spinal System (Medtronic Sofamor Danek; K043343) PathFinderTMSpinal System (Spinal Concepts; K030625) 5.4 Device Description The VertiFlexTM Spinal Screw System is… | 2004 |
| * | K030625 | Spinal Concepts Inc. PathfinderSummary page 1…ST36OTM Spinal Fixation System (Zimmer; K041925) CD HORIZON®Spinal System (Medtronic Sofamor Danek; K043343) PathFinderTMSpinal System (Spinal Concepts; K030625) 5.4 Device Description The VertiFlexTM Spinal Screw System is a posterior, non-cervical instrumentation system con… | 2003 |
What descends from it? (12)
See all 123 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 17 years and passes through 7 companies; a new generation was cleared every 2.1 years on median.
- 8 of the 54 ancestors have a recall of any class.
- Of its descendants, K073245 (Vertiflex, Inc., 2008) has gone furthest, with 10 descendants of its own.
- 5 other devices also cite its predicate K043232.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · MNH
8in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · MNH
93in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNH
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNH
89in 2025
MAUDE reports naming product code MNH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 5 | 123 | 0 | 18 |
| 2008 | 13 | 65 | 0 | 30 |
| 2009 | 13 | 151 | 7 | 45 |
| 2010 | 10 | 106 | 0 | 59 |
| 2011 | 17 | 171 | 0 | 107 |
| 2012 | 7 | 93 | 1 | 433 |
| 2013 | 10 | 124 | 1 | 464 |
| 2014 | 12 | 140 | 0 | 286 |
| 2015 | 10 | 99 | 0 | 152 |
| 2016 | 8 | 93 | 1 | 216 |
| 2017 | 0 | — | 0 | 174 |
| 2018 | 0 | — | 0 | 129 |
| 2019 | 0 | — | 0 | 403 |
| 2020 | 0 | — | 0 | 432 |
| 2021 | 0 | — | 0 | 531 |
| 2022 | 0 | — | 0 | 265 |
| 2023 | 0 | — | 0 | 121 |
| 2024 | 0 | — | 0 | 302 |
| 2025 | 0 | — | 0 | 89 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
When used as a posterior, noncervical pedicle screw system, the VertiFlexTM Spinal 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 of the thoracic, lumbar, and sacral spine: * Degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by…
Read the full statement (116 words)
When used as a posterior, noncervical pedicle screw system, the VertiFlexTM Spinal 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 of the thoracic, lumbar, and sacral spine:
* Degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies;
* Severe spondylolisthesis (Grades 3 and 4) of the L5-SI vertebra;
* Degenerative spondylolisthesis;
* Trauma (i.e., fracture or dislocation);
* Spinal stenosis;
* Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis);
* Tumor;
* Pseudoarthrosis; and/or
* Failed previous fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062670 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062670: Vertiflex Spinal 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/K062670
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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