510(k) · Cleared
ClearedNuvasive Bendini Spinal Rod Bending System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nuvasive, Inc. · OLO Orthopedic Stereotaxic Instrument
Cleared on Dec 7, 2012 as substantially equivalent to K111811 (Nuvasive, Inc., 2011) and 1 other predicate after a 91-day review. Its family tree reaches back 2 generations to 2005. 35 later devices descend from it.
- Decided
- Dec 7, 2012
- Review
- 91 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K050438 (2005). 3 ancestors in all, the oldest K033621 (2004). 35 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK050438 Stealthstation System UpdateMedtronic Surgical Navigation Technologies · 2005 · Recalled
- 1 generation backK111811 Bendini (TM) Spinal Rod Bending SystemNuvasive, Inc. · 2011
- This deviceK122742 Nuvasive Bendini Spinal Rod Bending SystemNuvasive, Inc. · 2012
- Descendant · cites it directly · 33 of its ownK123307 Nuvasive NVM5 SystemNuvasive, Inc. · 2013
- Descendant · 2 generations on · 24 of its ownK132694 Nuvasive NVM5 SystemNu Vasive, Incorporated · 2014
- Descendant · 3 generations on · 23 of its ownK141968 Nuvasive NVM5 SystemNuvasive, Inc. · 2014
- Descendant · 4 generations on · 22 of its ownK143641 NuVasive NVM5 SystemNu Vasive, Incorporated · 2015 · Recalled
- Descendant · 5 generations on · 13 of its ownK152942 NuVasiveNVM5 SystemNu Vasive, Incorporated · 2016
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 35 · See all- K123307Nuvasive NVM5 SystemNuvasive, Inc. · 2013 · cites it directly33descendants
- K132694Nuvasive NVM5 SystemNu Vasive, Incorporated · 2014 · 2 generations on24descendants
- K141968Nuvasive NVM5 SystemNuvasive, Inc. · 2014 · 3 generations on23descendants
- K143641NuVasive NVM5 SystemNu Vasive, Incorporated · 2015 · 4 generations on22descendants
- K152942NuVasiveNVM5 SystemNu Vasive, Incorporated · 2016 · 5 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K050438 | Stealthstation System Update | Medtronic Surgical Navigation Technologies | 2005 | 11 |
| −1 | K111811 | Bendini (TM) Spinal Rod Bending System | Nuvasive, Inc. | 2011 | — |
| 0 (this device) | K122742 | Nuvasive Bendini Spinal Rod Bending System | Nuvasive, Inc. | 2012 | — |
| +1 | K123307 | Nuvasive NVM5 System | Nuvasive, Inc. | 2013 | — |
| +2 | K132694 | Nuvasive NVM5 System | Nu Vasive, Incorporated | 2014 | — |
| +3 | K141968 | Nuvasive NVM5 System | Nuvasive, Inc. | 2014 | — |
| +4 | K143641 | NuVasive NVM5 System | Nu Vasive, Incorporated | 2015 | 1 |
| +5 | K152942 | NuVasiveNVM5 System | Nu Vasive, Incorporated | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 4 | 0 |
| 2018 | 3 | 0 |
| 2019 | 4 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 4 | 0 |
| 2024 | 3 | 0 |
| 2025 | 3 | 0 |
| 2026 | 3 | 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 OLO? 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 OLO device
- #1 K240662 Spine Guidance Software (version 5.0); Xia 3/…score 23.7 · 15 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 |
|---|---|---|---|
| * | K111811 | Bendini (TM) Spinal Rod Bending SystemSummary page 2…rpreted by a proprietary set of algorithms. The main technological differences between the subject Bendini Spinal Rod Bending System and the predicate device, K 111811, are the following: " Bendini IR Stylus Handle - modification to incorporate integrated reflective 1k markers in… | 2011 |
| * | K033621 | Ndi Passive SpheresSummary page 1…subject Bendini Spinal Rod Bending System is substantially equivalent to the following devices: " KI 111811 - Bendini Spinal Rod Bending System " K033621 - Northern Digital Inc. (NDI) Passive Spheres D. Device Description The NuVasive Bendini Spinal Rod Bending System… | 2004 |
What descends from it? (35)
See all 352 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 7 years and passes through 2 companies; a new generation was cleared every 6.5 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K123307 (Nuvasive, Inc., 2013) has gone furthest, with 33 descendants of its own.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · OLO
40in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OLO
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLO
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · OLO
3,306in 2025
MAUDE reports naming product code OLO, 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 | 1 |
| 2009 | 11 | 126 | 0 | 4 |
| 2010 | 9 | 113 | 1 | 4 |
| 2011 | 11 | 138 | 1 | 10 |
| 2012 | 7 | 129 | 1 | 60 |
| 2013 | 7 | 137 | 0 | 36 |
| 2014 | 10 | 119 | 3 | 245 |
| 2015 | 10 | 176 | 2 | 466 |
| 2016 | 14 | 120 | 3 | 750 |
| 2017 | 33 | 91 | 2 | 1,076 |
| 2018 | 24 | 97 | 1 | 1,230 |
| 2019 | 35 | 95 | 1 | 1,585 |
| 2020 | 34 | 89 | 6 | 2,746 |
| 2021 | 28 | 91 | 0 | 1,696 |
| 2022 | 40 | 89 | 5 | 1,568 |
| 2023 | 45 | 90 | 7 (1) | 1,493 |
| 2024 | 44 | 90 | 4 | 2,353 |
| 2025 | 40 | 119 | 1 | 3,306 |
| 2026 | 42 | 109 | 6 | — |
What is it indicated for?
The Bendini Spinal Rod Bending System is used to locate spinal implant system instrumentation (screws, hooks) to determine their relative location to one another to generate bend instructions to shape a spinal rod. A surgeon is able to use those instructions and bend a rod using the Bendini Bender, a mechanical rod bender.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122742 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122742: Nuvasive Bendini Spinal Rod Bending System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122742
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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