510(k) Report

510(k) · Cleared

Cleared

VyLink™ Spinal Screw System

K213750510(k) TraditionalCleared Feb 28, 202290-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

Vy Spine, LLC · NKB Thoracolumbosacral Pedicle Screw System

Cleared on Feb 28, 2022 as substantially equivalent to K081978 (Reliance Medical Systems, LLC, 2009) and 6 other predicates after a 90-day review. Its family tree reaches back 19 generations to 2004. 1 later device descends from it.

Decided
Feb 28, 2022
Review
90 days
Class
Class II
Product code
NKB
Recalls
None
Predicates
7

Its longest line of descent runs back 19 generations to K040583 (2004). 303 ancestors in all, the oldest K781443 (1978). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2016: 3 other ancestors2015: 2 other ancestors2013: 1 other ancestor2012: 5 other ancestors2010: 10 other ancestors2009: 6 other ancestors2008: 17 other ancestors2007: 13 other ancestors2006: 19 other ancestors2005: 23 other ancestors2004: 29 other ancestors2003: 18 other ancestors2002: 21 other ancestors1999: 10 other ancestors1996: 10 other ancestors1995: 8 other ancestors1994: 3 other ancestors1991: 1 other ancestor1988: 1 other ancestor2001: 23 other ancestors2000: 20 other ancestors1998: 15 other ancestors1997: 7 other ancestors1984: 1 other ancestor2011: 7 other ancestors1985: 1 other ancestor1978: 1 other ancestor1993: 2 other ancestors1992: 5 other ancestors1990: 2 other ancestors2023: 1 descendant cleared×7: 7 generations cleared close together, K040583 (2004), K041118 (2004), K042025 (2004), K043151 (2005), K050809 (2005), K052187 (2005), K053101 (2006) ×2: 2 generations cleared close together, K091442 (2009), K091974 (2009) K102555 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2010×2: 2 generations cleared close together, K112473 (2011), K113174 (2011) K121630 · Range Spinal System · K2m, Inc. · 2012K130932 · Firebird Spinal Fixation System · Orthofix, Inc. · 2013 · recalledK151488 · Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System · Orthofix, Inc. · 2015 · recalledK153428 · Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System · Orthofix, Inc. · 2016 · recalledK171082 · Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline Fixation Screw, Phoenix CDX MIS Spinal Fixation System, Firebird NXG Spinal Fixation System · Orthofix, Inc. · 2017 · recalledK180179 · Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird® NXG Spinal Fixation System; Phoenix® Minimally Invasive Spinal Fixation System; Phoenix® CDX™ Minimally Invasive Spinal Fixation System; JANUS® Midline Fixation Screw; JANUS® Fenestrated Screw · Orthofix, Inc. · 2018K210874 · Reliance Spinal Screw System · Reliance Medical Systems, LLC · 202119801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 6 other ancestors2 generations back: 26 other ancestors3 generations back: 38 other ancestors4 generations back: 40 other ancestors5 generations back: 31 other ancestors6 generations back: 30 other ancestors7 generations back: 28 other ancestors8 generations back: 37 other ancestors9 generations back: 21 other ancestors10 generations back: 10 other ancestors11 generations back: 15 other ancestors12 generations back: 2 other ancestors 1 generation forward: 1 descendant K210874 · Reliance Spinal Screw System · Reliance Medical Systems, LLC · 2021K180179 · Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird® NXG Spinal Fixation System; Phoenix® Minimally Invasive Spinal Fixation System; Phoenix® CDX™ Minimally Invasive Spinal Fixation System; JANUS® Midline Fixation Screw; JANUS® Fenestrated Screw · Orthofix, Inc. · 2018K171082 · Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline Fixation Screw, Phoenix CDX MIS Spinal Fixation System, Firebird NXG Spinal Fixation System · Orthofix, Inc. · 2017 · recalledK153428 · Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System · Orthofix, Inc. · 2016 · recalledK151488 · Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System · Orthofix, Inc. · 2015 · recalledK130932 · Firebird Spinal Fixation System · Orthofix, Inc. · 2013 · recalledK121630 · Range Spinal System · K2m, Inc. · 2012K113174 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2011 · recalledK112473 · CD Horizon Spinal System · Medtronic Sofamor Danek, Inc. · 2011K102555 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2010K091974 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2009 · recalledK091442 · CD Horizon Spinal System · Medtronic Sofamor Danek · 2009K053101 · CD Horizon Spinal System · Medtronic Sofamor Danek · 2006K052187 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2005K050809 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2005K043151 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2005K042025 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek, Inc. · 2004 · recalledK041118 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek · 2004K040583 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2004−15−10−50
  1. Root · 19 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 15 generations between
  3. 3 generations backK171082 Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System…Orthofix, Inc. · 2017 · Recalled
  4. 2 generations backK180179 Firebird® Spinal Fixation Systems: Firebird System; Firebird…Orthofix, Inc. · 2018
  5. 1 generation backK210874 Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2021
  6. This deviceK213750 VyLink™ Spinal Screw SystemVy Spine, LLC · 2022
  7. Descendant · cites it directly · 0 of its ownK231744 VyLink™ Spinal Screw SystemVy Spine, LLC · 2023
Show all 19 generations
  1. Root · 19 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 18 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  3. 17 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
  4. 16 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  5. 15 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
  6. 14 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  7. 13 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
  8. 12 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
  9. 11 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
  10. 10 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
  11. 9 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
  12. 8 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
  13. 7 generations backK121630 Range Spinal SystemK2m, Inc. · 2012
  14. 6 generations backK130932 Firebird Spinal Fixation SystemOrthofix, Inc. · 2013 · Recalled
  15. 5 generations backK151488 Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc. · 2015 · Recalled
  16. 4 generations backK153428 Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc. · 2016 · Recalled
  17. 3 generations backK171082 Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System…Orthofix, Inc. · 2017 · Recalled
  18. 2 generations backK180179 Firebird® Spinal Fixation Systems: Firebird System; Firebird…Orthofix, Inc. · 2018
  19. 1 generation backK210874 Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2021
  20. This deviceK213750 VyLink™ Spinal Screw SystemVy Spine, LLC · 2022

Most influential descendants

Showing 1 of 1 · See all
  • K231744VyLink™ Spinal Screw SystemVy Spine, LLC · 2023 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−19K040583Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−18K041118Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−17K042025Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20044
−16K043151Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−15K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005—
−14K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−13K053101CD Horizon Spinal SystemMedtronic Sofamor Danek2006—
−12K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009—
−11K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20091
−10K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010—
−9K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011—
−8K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20111
−7K121630Range Spinal SystemK2m, Inc.2012—
−6K130932Firebird Spinal Fixation SystemOrthofix, Inc.20131
−5K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.20151
−4K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.20161
−3K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS…Orthofix, Inc.20171
−2K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System…Orthofix, Inc.2018—
−1K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC2021—
0 (this device)K213750VyLink™ Spinal Screw SystemVy Spine, LLC2022—
+1K231744VyLink™ Spinal Screw SystemVy Spine, LLC2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
198410
198510
198810
199020
199110
199250
199320
199430
199580
1996100
199770
1998150
1999100
2000200
2001230
2002210
2003180
2004290
2005230
2006190
2007130
2008170
200960
2010100
201170
201250
201310
201520
201630

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202310
FIG. 1 — Lineage of K213750, 2004–2023Source: 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 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. #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K081978Reliance Spinal Screw System
Summary page 4
…NKB, KWP, KWQ Substantial Equivalence The VyLink™ Spinal Screw is substantially equivalent to the legally marketed primary predicate Reliance Spinal Screw (K081978, K101112, K110896, K123521, K152131, K162066, and K210874). The VyLink™ Spinal Screw is equivalent to these commercially availabl…
Reliance Medical Systems, LLC2009—
*K101112Reliance Spinal Screw System
Summary page 4
…NKB, KWP, KWQ Substantial Equivalence The VyLink™ Spinal Screw is substantially equivalent to the legally marketed primary predicate Reliance Spinal Screw (K081978, K101112, K110896, K123521, K152131, K162066, and K210874). The VyLink™ Spinal Screw is equivalent to these commercially available devices…
Reliance Medical Systems2010—
*K110896Reliance Spinal Screw System
Summary page 4
…KWP, KWQ Substantial Equivalence The VyLink™ Spinal Screw is substantially equivalent to the legally marketed primary predicate Reliance Spinal Screw (K081978, K101112, K110896, K123521, K152131, K162066, and K210874). The VyLink™ Spinal Screw is equivalent to these commercially available devices in terms…
Reliance Medical Systems, LLC2012—
*K123521Reliance Spinal Screw System
Summary page 4
…Substantial Equivalence The VyLink™ Spinal Screw is substantially equivalent to the legally marketed primary predicate Reliance Spinal Screw (K081978, K101112, K110896, K123521, K152131, K162066, and K210874). The VyLink™ Spinal Screw is equivalent to these commercially available devices in terms of mater…
Reliance Medical Systems, LLC2013—
*K152131Reliance Spinal Screw System
Summary page 4
…ial Equivalence The VyLink™ Spinal Screw is substantially equivalent to the legally marketed primary predicate Reliance Spinal Screw (K081978, K101112, K110896, K123521, K152131, K162066, and K210874). The VyLink™ Spinal Screw is equivalent to these commercially available devices in terms of material, inte…
Reliance Medical Systems, LLC2015—
*K162066Reliance Spinal Screw System
Summary page 4
…alence The VyLink™ Spinal Screw is substantially equivalent to the legally marketed primary predicate Reliance Spinal Screw (K081978, K101112, K110896, K123521, K152131, K162066, and K210874). The VyLink™ Spinal Screw is equivalent to these commercially available devices in terms of material, intended use,…
Reliance Medical Systems, LLC2016—
*K210874Reliance Spinal Screw System
Summary page 4
…Link™ Spinal Screw is substantially equivalent to the legally marketed primary predicate Reliance Spinal Screw (K081978, K101112, K110896, K123521, K152131, K162066, and K210874). The VyLink™ Spinal Screw is equivalent to these commercially available devices in terms of material, intended use, levels of at…
Reliance Medical Systems, LLC2021—

Also cleared against K081978: 5 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230

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 7 companies; a new generation was cleared every 10 months on median.
  • 36 of the 303 ancestors have a recall of any class.
  • Of its descendants, K231744 (Vy Spine, LLC, 2023) has gone furthest, with 0 descendants of its own.
  • 5 other devices also cite its predicate K081978.

How does its category compare?

All NKB devices

NKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.

FDA decisions per year · NKB

24in 2025

2007: 382008: 362009: 442010: 372011: 482012: 602013: 352014: 462015: 552016: 502017: 632018: 562019: 392020: 482021: 322022: 342023: 442024: 392025: 242026 (partial year): 30
2007high 63 (2017) · low 24 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NKB

61in 2025

2007: 87 days median2008: 59 days median2009: 71 days median2010: 111 days median2011: 84 days median2012: 79 days median2013: 73 days median2014: 90 days median2015: 90 days median2016: 84 days median2017: 69 days median2018: 61 days median2019: 84 days median2020: 68 days median2021: 61 days median2022: 88 days median2023: 72 days median2024: 57 days median2025: 61 days median2026 (partial year): 91 days median
2007high 111 (2010) · low 57 (2024)2026

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

Recalls per year · NKB

1in 2025

2007: 42008: 52009: 332010: 42011: 32012: 132014: 3, 1 Class I2015: 32016: 12017: 12018: 32019: 12020: 12022: 52023: 22024: 32025: 12026 (partial year): 3
2007high 33 (2009) · low 0 (2013)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · NKB

1,171in 2025

2007: 342008: 822009: 1712010: 4622011: 5772012: 1,7472013: 1,9622014: 1,6712015: 1,4462016: 1,5852017: 1,6182018: 1,6842019: 1,9152020: 2,0762021: 1,7452022: 1,3392023: 9192024: 1,6142025: 1,171
2007high 2,076 (2020) · low 34 (2007)2025

MAUDE reports naming product code NKB, 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
20073887434
20083659582
2009447133171
2010371114462
201148843577
20126079131,747
2013357301,962
201446903 (1)1,671
2015559031,446
2016508411,585
2017636911,618
2018566131,684
2019398411,915
2020486812,076
2021326101,745
2022348851,339
202344722919
2024395731,614
2025246111,171
202630913—

What is it indicated for?

The VyLink™ Spinal Screw System is a pedicle screw system 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: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative…

Read the full statement (310 words)

The VyLink™ Spinal Screw System is a pedicle screw system 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: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The VyLink™ Spinal Screw System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5–S1 vertebra in skeletally-mature patients receiving fusion by autogenous bone graft and having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

When used posteriorly, the VyLink™ Spinal Screw System is also a hook and sacral/iliac screw fixation system of the noncervical spine indicated for: spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis). Levels of fixation are for the thoracic, lumbar and sacral spine.

When used in a percutaneous, posterior approach with MIS instrumentation, the VyLink™ Spinal Screw System components are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudarthrosis, and failed previous fusion in skeletally-mature patients.

The VyLink™ Spinal Screw System, when used with staples and two rods as an anterior thoracic/lumbar screw fixation system, is indicated for spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous-failed fusion (pseudarthrosis).

The Vy Spine™ VySpan™ PCT System can also be linked to the Vy Spine™ VyLink™ Screw System using the dual diameter rods.

Indications for use as stated in the FDA summary.

Also cleared against K081978

5 other devices cite the same predicate.

  • K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2016
  • K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2015
  • K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2013
  • K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2012
  • K101112Reliance Spinal Screw SystemReliance Medical Systems · 2010

More from Vy Spine, LLC

21 FDA decisions under this applicant name. See the company

  • K260697VyPlate™ Anterior Cervical Plate SystemVy Spine, LLC · 2026
  • K253432DiversiVy™ Facet Screw SystemVy Spine, LLC · 2026
  • K253158VyBrate™ VBR SystemVy Spine, LLC · 2026
  • K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC · 2025
  • K242784Vy Spine™ VyLam™ Laminoplasty SystemVy Spine, LLC · 2024

Recent decisions in NKB

The NKB category page

  • K261217AnyPlus II Spinal Fixation SystemGS Medical Co., Ltd. · 2026
  • K263062NOVIX Pedicle Screw SystemTdm Co., Ltd. · 2026
  • K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC · 2026
  • K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc. · 2026
  • K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd. · 2026

https://510kreport.com/device/K213750 · printed Nov 5, 2026

Cite this page

510(k) Report. “K213750: VyLink™ 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/K213750

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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