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 Jul 15, 2016 as substantially equivalent to K142053 (Zimmer Spine, Inc., 2014) and 1 other predicate after a 71-day review. Its family tree reaches back 11 generations to 1993. 3 later devices descend from it.
- Decided
- Jul 15, 2016
- Review
- 71 days
- Class
- Class II
- Product code
- OWI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K925812 (1993). 32 ancestors in all, the oldest K781443 (1978). 3 later devices descend from it, 1 citing it directly.
- Root · 11 generations backK925812 Titanium Songer Cable SystemSofamor Danek Mfg., Inc. · 1993
- 7 generations between
- 3 generations backK133617 Jazz SystemImplanet, S.A. · 2014
- 2 generations backK143759 JAZZ SystemImplanet, S.A. · 2015
- 1 generation backK151740 JAZZ SystemImplanet, S.A. · 2015
- This deviceK161265 NuVasive® VersaTie SystemNu Vasive, Incorporated · 2016
- Descendant · cites it directly · 2 of its ownK173117 NuVasive® VersaTie™ SystemNuvasive, Inc. · 2017
- Descendant · 2 generations on · 0 of its ownK191217 Jazz PFImplanet, S.A. · 2019
- Descendant · 2 generations on · 0 of its ownK190418 NuVasive® VersaTie® SystemNu Vasive, Incorporated · 2019
Show all 11 generations
- Root · 11 generations backK925812 Titanium Songer Cable SystemSofamor Danek Mfg., Inc. · 1993
- 10 generations backK974020 Spinal Concepts, Inc., Cfix Cable SystemSpinal Concepts, Inc. · 1997
- 9 generations backK060009 Abbott Spine Universal Clamp SystemAbbott Spine, Inc. · 2006
- 8 generations backK081622 Universal Clamp Stainless Steel SystemAbbott Spine, Inc. · 2008
- 7 generations backK091190 Universal Clamp Stainless Steel System, Models SNA027-0-30060…Zimmer Spine, Inc. · 2009
- 6 generations backK110348 Universal Clamp Spinal Fixation SystemZimmer Spine · 2011
- 5 generations backK121541 Jazz SystemImplanet, S.A. · 2012
- 4 generations backK132287 Jazz SystemHogan Lovells US LLP · 2013
- 3 generations backK133617 Jazz SystemImplanet, S.A. · 2014
- 2 generations backK143759 JAZZ SystemImplanet, S.A. · 2015
- 1 generation backK151740 JAZZ SystemImplanet, S.A. · 2015
- This deviceK161265 NuVasive® VersaTie SystemNu Vasive, Incorporated · 2016
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K925812 | Titanium Songer Cable System | Sofamor Danek Mfg., Inc. | 1993 | — |
| −10 | K974020 | Spinal Concepts, Inc., Cfix Cable System | Spinal Concepts, Inc. | 1997 | — |
| −9 | K060009 | Abbott Spine Universal Clamp System | Abbott Spine, Inc. | 2006 | — |
| −8 | K081622 | Universal Clamp Stainless Steel System | Abbott Spine, Inc. | 2008 | — |
| −7 | K091190 | Universal Clamp Stainless Steel System, Models SNA027-0-30060, SNA027-0-30063 | Zimmer Spine, Inc. | 2009 | — |
| −6 | K110348 | Universal Clamp Spinal Fixation System | Zimmer Spine | 2011 | — |
| −5 | K121541 | Jazz System | Implanet, S.A. | 2012 | — |
| −4 | K132287 | Jazz System | Hogan Lovells US LLP | 2013 | — |
| −3 | K133617 | Jazz System | Implanet, S.A. | 2014 | — |
| −2 | K143759 | JAZZ System | Implanet, S.A. | 2015 | — |
| −1 | K151740 | JAZZ System | Implanet, S.A. | 2015 | — |
| 0 (this device) | K161265 | NuVasive® VersaTie System | Nu Vasive, Incorporated | 2016 | — |
| +1 | K173117 | NuVasive® VersaTie™ System | Nuvasive, Inc. | 2017 | — |
| +2 | K191217 | Jazz PF | Implanet, S.A. | 2019 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 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 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? (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 |
|---|---|---|---|
| * | K142053 | Universal Clamp Spinal Fixation SystemSummary page 4…OWI C. Predicate Devices The subject device is substantially equivalent to the primary predicate device Zimmer® Universal Clamp Spinal Fixation System (K142053), and additional predicate device Implant, S.A. JAZZTM System (K151740). NuVasive Reline® System (K143684) is a referen… | 2014 |
| * | K151740 | JAZZ SystemSummary page 4…uivalent to the primary predicate device Zimmer® Universal Clamp Spinal Fixation System (K142053), and additional predicate device Implant, S.A. JAZZTM System (K151740). NuVasive Reline® System (K143684) is a reference device. D. Device Description The NuVasive® VersaTie System is par… | 2015 |
| † | K143684 | NuVasive Reline System | 2015 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173117 | NuVasive® VersaTie™ System | 2017 | 2 |
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 23 years and passes through 8 companies; a new generation was cleared every 1.1 years on median.
- 1 of the 32 ancestors has a recall of any class.
- Of its descendants, K173117 (Nuvasive, Inc., 2017) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K142053.
How does its category compare?
All OWI devicesOWI Bone Fixation Cerclage, Sublaminar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 NuVasive® VersaTie System is a temporary implant for use in orthopedic 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 NuVasive® VersaTie System is a temporary implant for use in orthopedic 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 other implants.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K161265 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161265: 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/K161265
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