510(k) · Cleared
ClearedNuVasive® VersaTie® System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nu Vasive, Incorporated · OWI Bone Fixation Cerclage, Sublaminar
Cleared on Mar 21, 2019 as substantially equivalent to K173117 (Nuvasive, Inc., 2017) after a 28-day review. Its family tree reaches back 13 generations to 1993.
- Decided
- Mar 21, 2019
- Review
- 28 days
- Class
- Class II
- Product code
- OWI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K925812 (1993). 34 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet.
- Root · 13 generations backK925812 Titanium Songer Cable SystemSofamor Danek Mfg., Inc. · 1993
- 9 generations between
- 3 generations backK151740 JAZZ SystemImplanet, S.A. · 2015
- 2 generations backK161265 NuVasive® VersaTie SystemNu Vasive, Incorporated · 2016
- 1 generation backK173117 NuVasive® VersaTie™ SystemNuvasive, Inc. · 2017
- This deviceK190418 NuVasive® VersaTie® SystemNu Vasive, Incorporated · 2019
Show all 13 generations
- Root · 13 generations backK925812 Titanium Songer Cable SystemSofamor Danek Mfg., Inc. · 1993
- 12 generations backK974020 Spinal Concepts, Inc., Cfix Cable SystemSpinal Concepts, Inc. · 1997
- 11 generations backK060009 Abbott Spine Universal Clamp SystemAbbott Spine, Inc. · 2006
- 10 generations backK081622 Universal Clamp Stainless Steel SystemAbbott Spine, Inc. · 2008
- 9 generations backK091190 Universal Clamp Stainless Steel System, Models SNA027-0-30060…Zimmer Spine, Inc. · 2009
- 8 generations backK110348 Universal Clamp Spinal Fixation SystemZimmer Spine · 2011
- 7 generations backK121541 Jazz SystemImplanet, S.A. · 2012
- 6 generations backK132287 Jazz SystemHogan Lovells US LLP · 2013
- 5 generations backK133617 Jazz SystemImplanet, S.A. · 2014
- 4 generations backK143759 JAZZ SystemImplanet, S.A. · 2015
- 3 generations backK151740 JAZZ SystemImplanet, S.A. · 2015
- 2 generations backK161265 NuVasive® VersaTie SystemNu Vasive, Incorporated · 2016
- 1 generation backK173117 NuVasive® VersaTie™ SystemNuvasive, Inc. · 2017
- This deviceK190418 NuVasive® VersaTie® SystemNu Vasive, Incorporated · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K925812 | Titanium Songer Cable System | Sofamor Danek Mfg., Inc. | 1993 | — |
| −12 | K974020 | Spinal Concepts, Inc., Cfix Cable System | Spinal Concepts, Inc. | 1997 | — |
| −11 | K060009 | Abbott Spine Universal Clamp System | Abbott Spine, Inc. | 2006 | — |
| −10 | K081622 | Universal Clamp Stainless Steel System | Abbott Spine, Inc. | 2008 | — |
| −9 | K091190 | Universal Clamp Stainless Steel System, Models SNA027-0-30060, SNA027-0-30063 | Zimmer Spine, Inc. | 2009 | — |
| −8 | K110348 | Universal Clamp Spinal Fixation System | Zimmer Spine | 2011 | — |
| −7 | K121541 | Jazz System | Implanet, S.A. | 2012 | — |
| −6 | K132287 | Jazz System | Hogan Lovells US LLP | 2013 | — |
| −5 | K133617 | Jazz System | Implanet, S.A. | 2014 | — |
| −4 | K143759 | JAZZ System | Implanet, S.A. | 2015 | — |
| −3 | K151740 | JAZZ System | Implanet, S.A. | 2015 | — |
| −2 | K161265 | NuVasive® VersaTie System | Nu Vasive, Incorporated | 2016 | — |
| −1 | K173117 | NuVasive® VersaTie™ System | Nuvasive, Inc. | 2017 | — |
| 0 (this device) | K190418 | NuVasive® VersaTie® System | Nu Vasive, Incorporated | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1992 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 3 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2014 | 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 OWI? 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 OWI device
- #1 K253615 Invictus Bands Systemscore 20.7 · 33 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 |
|---|---|---|---|
| * | K173117 | NuVasive® VersaTie™ SystemSummary page 4…t Code: OWI C. Predicate Devices The subject device is substantially equivalent to the primary predicate device NuVasive VersaTie System (K173117). NuVasive Sterile MLX and APX Interbody Devices (K151374) was used as a reference device. D. Device Description The… | 2017 |
| † | K151374 | NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable… | 2015 |
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 26 years and passes through 9 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 34 ancestors has a recall of any class.
- 1 other device also cites its predicate K173117.
How does its category compare?
All OWI devicesOWI Bone Fixation Cerclage, Sublaminar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · OWI
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · OWI
60in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OWI
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OWI
6in 2025
MAUDE reports naming product code OWI, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 3 | 92 | 0 | 1 |
| 2015 | 3 | 93 | 0 | 1 |
| 2016 | 5 | 98 | 0 | 6 |
| 2017 | 7 | 77 | 0 | 6 |
| 2018 | 4 | 156 | 0 | 2 |
| 2019 | 3 | 51 | 0 | 13 |
| 2020 | 3 | 60 | 1 | 8 |
| 2021 | 1 | — | 0 | 5 |
| 2022 | 1 | — | 0 | 6 |
| 2023 | 2 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 6 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The VersaTie System is a temporary implant for use in orthopaedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications: 1. Spinal trauma surgery, used in sublaminar or facet wiring techniques. 2. Spinal reconstructive surgery, incorporated into constructs for the purpose of…
Read the full statement (134 words)
The VersaTie System is a temporary implant for use in orthopaedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications:
1. Spinal trauma surgery, used in sublaminar or facet wiring techniques.
2. Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, kyphosis and spondylolisthesis.
3. Spinal degenerative surgery, as an adjunct to spinal fusions.
The VersaTie System may also be used in conjunction with other medical implants made of titanium alloy or cobalt chromium alloy whenever “wiring” may help secure the attachment of the other implants.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190418 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190418: NuVasive® VersaTie® System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190418
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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