510(k) · Cleared
ClearedExtended Vertiflex Spinal Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vertiflex, Inc. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Feb 15, 2008 as substantially equivalent to K062670 (Vertiflex (Tm), Incorporated, 2007) after an 88-day review. Its family tree reaches back 9 generations to 1990. 10 later devices descend from it.
- Decided
- Feb 15, 2008
- Review
- 88 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K901587 (1990). 55 ancestors in all. 10 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK901587 TSRH Sacral L-ConnectorDanek Medical, Inc. · 1990
- 5 generations between
- 3 generations backK032739 Ucr Spinal SystemSeaspine · 2003
- 2 generations backK043232 Ucr Spinal SystemSeaspine · 2004 · Recalled
- 1 generation backK062670 Vertiflex Spinal Screw SystemVertiflex (Tm), Incorporated · 2007
- This deviceK073245 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
- Descendant · 2 generations on · 1 of its ownK141282 PGS 5.5 MM Cannulated Pedicle ScrewPinnacle Spine Group · 2014
Show all 9 generations
- Root · 9 generations backK901587 TSRH Sacral L-ConnectorDanek Medical, Inc. · 1990
- 8 generations backK950099 Synergy (TM) TI Posterior Spinal SystemBuckman Co., Inc. · 1997
- 7 generations backK973836 Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the…Cross Medical Products, Inc. · 1998
- 6 generations backK974749 Synergy Closed Variable Locking Screw (VLS), Part of the Cross…Cross Medical Products, Inc. · 1998
- 5 generations backK993503 Haider-Ucr Spinal SystemInternational Advanced Medical Enterprises, Inc. · 2000
- 4 generations backK021623 Ucr Spinal System, 5.5MM, 8.0MM Screws & InstrumentsIame, Inc. · 2002
- 3 generations backK032739 Ucr Spinal SystemSeaspine · 2003
- 2 generations backK043232 Ucr Spinal SystemSeaspine · 2004 · Recalled
- 1 generation backK062670 Vertiflex Spinal Screw SystemVertiflex (Tm), Incorporated · 2007
- This deviceK073245 Extended Vertiflex Spinal Screw SystemVertiflex, Inc. · 2008
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- 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
- K141282PGS 5.5 MM Cannulated Pedicle ScrewPinnacle Spine Group · 2014 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K901587 | TSRH Sacral L-Connector | Danek Medical, Inc. | 1990 | — |
| −8 | K950099 | Synergy (TM) TI Posterior Spinal System | Buckman Co., Inc. | 1997 | — |
| −7 | K973836 | Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross… | Cross Medical Products, Inc. | 1998 | — |
| −6 | K974749 | Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy… | Cross Medical Products, Inc. | 1998 | — |
| −5 | K993503 | Haider-Ucr Spinal System | International Advanced Medical Enterprises, Inc. | 2000 | — |
| −4 | K021623 | Ucr Spinal System, 5.5MM, 8.0MM Screws & Instruments | Iame, Inc. | 2002 | — |
| −3 | K032739 | Ucr Spinal System | Seaspine | 2003 | — |
| −2 | K043232 | Ucr Spinal System | Seaspine | 2004 | 1 |
| −1 | K062670 | Vertiflex Spinal Screw System | Vertiflex (Tm), Incorporated | 2007 | — |
| 0 (this device) | 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 | — |
| +2 | K141282 | PGS 5.5 MM Cannulated Pedicle Screw | Pinnacle Spine Group | 2014 | — |
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 |
|---|---|---|
| 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 NKB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NKB device
- #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K062670 | Vertiflex Spinal Screw SystemSummary page 1…s substantially equivalent, in whole or in part, to the following commercially available predicate devices: VerfiFlex®Spinal Screw System (VertiFlex®t, Inc., K062670) 5.4 Device Description The Extended VertiFlex®R Spinal Screw System is a posterior, non-cervical instrumentation s… | 2007 |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102870 | Exactech Proliant Polyaxial Pedicle Screw System | 2011 | 9 |
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.
- 8 of the 55 ancestors have a recall of any class.
- Of its descendants, K102870 (Exactech, Inc., 2011) has gone furthest, with 9 descendants of its own.
- 2 other devices also cite its predicate K062670.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · NKB
24in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKB
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKB
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NKB
1,171in 2025
MAUDE reports naming product code NKB, 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 | 38 | 87 | 4 | 34 |
| 2008 | 36 | 59 | 5 | 82 |
| 2009 | 44 | 71 | 33 | 171 |
| 2010 | 37 | 111 | 4 | 462 |
| 2011 | 48 | 84 | 3 | 577 |
| 2012 | 60 | 79 | 13 | 1,747 |
| 2013 | 35 | 73 | 0 | 1,962 |
| 2014 | 46 | 90 | 3 (1) | 1,671 |
| 2015 | 55 | 90 | 3 | 1,446 |
| 2016 | 50 | 84 | 1 | 1,585 |
| 2017 | 63 | 69 | 1 | 1,618 |
| 2018 | 56 | 61 | 3 | 1,684 |
| 2019 | 39 | 84 | 1 | 1,915 |
| 2020 | 48 | 68 | 1 | 2,076 |
| 2021 | 32 | 61 | 0 | 1,745 |
| 2022 | 34 | 88 | 5 | 1,339 |
| 2023 | 44 | 72 | 2 | 919 |
| 2024 | 39 | 57 | 3 | 1,614 |
| 2025 | 24 | 61 | 1 | 1,171 |
| 2026 | 30 | 91 | 3 | — |
What is it indicated for?
When used as a posterior, noncervical pedicle screw system, the Extended VertiFlex® 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…
Read the full statement (117 words)
When used as a posterior, noncervical pedicle screw system, the Extended VertiFlex® 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-S1 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/K073245 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073245: Extended Vertiflex Spinal Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073245
Report an extraction error
Are you the manufacturer?
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