510(k) · Cleared
ClearedVyLink™ Spinal Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vy Spine, LLC · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Oct 13, 2023 as substantially equivalent to K213750 (Vy Spine, LLC, 2022) and 1 other predicate after a 121-day review. Its family tree reaches back 20 generations to 2004.
- Decided
- Oct 13, 2023
- Review
- 121 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 20 generations to K040583 (2004). 425 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet.
- Root · 20 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 16 generations between
- 3 generations backK180179 Firebird® Spinal Fixation Systems: Firebird System; Firebird…Orthofix, Inc. · 2018
- 2 generations backK210874 Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2021
- 1 generation backK213750 VyLink™ Spinal Screw SystemVy Spine, LLC · 2022
- This deviceK231744 VyLink™ Spinal Screw SystemVy Spine, LLC · 2023
Show all 20 generations
- Root · 20 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 19 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 18 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 17 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 16 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 15 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 14 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 13 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 12 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 11 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 10 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 9 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 8 generations backK121630 Range Spinal SystemK2m, Inc. · 2012
- 7 generations backK130932 Firebird Spinal Fixation SystemOrthofix, Inc. · 2013 · Recalled
- 6 generations backK151488 Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc. · 2015 · Recalled
- 5 generations backK153428 Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc. · 2016 · Recalled
- 4 generations backK171082 Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System…Orthofix, Inc. · 2017 · Recalled
- 3 generations backK180179 Firebird® Spinal Fixation Systems: Firebird System; Firebird…Orthofix, Inc. · 2018
- 2 generations backK210874 Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2021
- 1 generation backK213750 VyLink™ Spinal Screw SystemVy Spine, LLC · 2022
- This deviceK231744 VyLink™ Spinal Screw SystemVy Spine, LLC · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −19 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −18 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −17 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −16 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −15 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −14 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −13 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −12 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −11 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −10 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −9 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −8 | K121630 | Range Spinal System | K2m, Inc. | 2012 | — |
| −7 | K130932 | Firebird Spinal Fixation System | Orthofix, Inc. | 2013 | 1 |
| −6 | K151488 | Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System | Orthofix, Inc. | 2015 | 1 |
| −5 | K153428 | Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System | Orthofix, Inc. | 2016 | 1 |
| −4 | K171082 | Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS… | Orthofix, Inc. | 2017 | 1 |
| −3 | K180179 | Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System… | Orthofix, Inc. | 2018 | — |
| −2 | K210874 | Reliance Spinal Screw System | Reliance Medical Systems, LLC | 2021 | — |
| −1 | K213750 | VyLink™ Spinal Screw System | Vy Spine, LLC | 2022 | — |
| 0 (this device) | K231744 | VyLink™ Spinal Screw System | Vy Spine, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1984 | 2 | 0 |
| 1985 | 2 | 0 |
| 1986 | 2 | 0 |
| 1987 | 1 | 0 |
| 1988 | 3 | 0 |
| 1989 | 1 | 0 |
| 1990 | 4 | 0 |
| 1991 | 1 | 0 |
| 1992 | 7 | 0 |
| 1993 | 3 | 0 |
| 1994 | 8 | 0 |
| 1995 | 16 | 0 |
| 1996 | 12 | 0 |
| 1997 | 12 | 0 |
| 1998 | 20 | 0 |
| 1999 | 12 | 0 |
| 2000 | 27 | 0 |
| 2001 | 28 | 0 |
| 2002 | 28 | 0 |
| 2003 | 22 | 0 |
| 2004 | 32 | 0 |
| 2005 | 32 | 0 |
| 2006 | 23 | 0 |
| 2007 | 14 | 0 |
| 2008 | 21 | 0 |
| 2009 | 8 | 0 |
| 2010 | 12 | 0 |
| 2011 | 12 | 0 |
| 2012 | 7 | 0 |
| 2013 | 5 | 0 |
| 2014 | 2 | 0 |
| 2015 | 6 | 0 |
| 2016 | 7 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | K213750 | VyLink™ Spinal Screw SystemSummary page 5…NKB, KWP, KWQ, OUR Substantial Equivalence The VyLink™ Spinal Screw is substantially equivalent to the legally marketed primary predicate VyLink™ Spinal Screw System (K213750) and the additional predicate device SI-BONE iFuse Bedrock Granite Implant System (K222774). The VyLink™ Spinal Screw is equivale… | 2022 |
| * | K222774 | iFuse Bedrock Granite® Implant SystemSummary page 5…ivalent to the legally marketed primary predicate VyLink™ Spinal Screw System (K213750) and the additional predicate device SI-BONE iFuse Bedrock Granite Implant System (K222774). The VyLink™ Spinal Screw is equivalent to these commercially available devices in terms of material, intended use, levels of at… | 2022 |
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 7 companies; a new generation was cleared every 10 months on median.
- 57 of the 425 ancestors have a recall of any class.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
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 (417 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.
The Ø6.5mm and larger screws may be used for sacroiliac joint fusion. The VyLink™ Spinal Screw System when used in the sacroiliac joint is intended for sacroiliac joint fusion for the following conditions:
• Sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.
• To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
• Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231744 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231744: VyLink™ 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/K231744
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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