510(k) · Cleared
ClearedSpinal Elements Navigated Instruments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spinal Elements, Inc. · OLO Orthopedic Stereotaxic Instrument
Cleared on Dec 19, 2019 as substantially equivalent to K140454 (Medtronic Sofamor Danek USA, Inc., 2014) and 2 other predicates after a 259-day review. Its family tree reaches back 16 generations to 2004. 4 later devices descend from it.
- Decided
- Dec 19, 2019
- Review
- 259 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 16 generations to K040583 (2004). 152 ancestors in all, the oldest K841189 (1984). 4 later devices descend from it, 1 citing it directly.
- Root · 16 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 12 generations between
- 3 generations backK122862 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 2 generations backK141605 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014
- 1 generation backK143375 CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc. · 2015
- This deviceK190881 Spinal Elements Navigated InstrumentsSpinal Elements, Inc. · 2019
- Descendant · cites it directly · 3 of its ownK222516 Mercury® II Spinal SystemSpinal Elements, Inc. · 2022
- Descendant · 2 generations on · 2 of its ownK243916 Primus Spinal Fixation SystemSpinal Elements, Inc. · 2025
- Descendant · 3 generations on · 1 of its ownK251154 RIVA Posterior Fixation System; RIVA Posterior Fixation System…Ht Medical D.B.A. Xenix Medical · 2025
- Descendant · 4 generations on · 0 of its ownK262193 RIVA® Posterior Fixation System with NanoACTIV Surface Technology…Xenix Medical · 2026
Show all 16 generations
- Root · 16 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 15 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 14 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 13 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 12 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 11 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 10 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 9 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 8 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 7 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 6 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 5 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 4 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 3 generations backK122862 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 2 generations backK141605 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014
- 1 generation backK143375 CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc. · 2015
- This deviceK190881 Spinal Elements Navigated InstrumentsSpinal Elements, Inc. · 2019
Most influential descendants
Showing 4 of 4 · See all- K222516Mercury® II Spinal SystemSpinal Elements, Inc. · 2022 · cites it directly3descendants
- K243916Primus Spinal Fixation SystemSpinal Elements, Inc. · 2025 · 2 generations on2descendants
- K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical · 2025 · 3 generations on1descendant
- K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −15 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −14 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −13 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −12 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −11 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −10 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −9 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −8 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −7 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −6 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −5 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −4 | K121680 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| −3 | K122862 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| −2 | K141605 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2014 | — |
| −1 | K143375 | CD HORIZON Spinal System, Medtronic Navigated Reusable Instruments | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| 0 (this device) | K190881 | Spinal Elements Navigated Instruments | Spinal Elements, Inc. | 2019 | — |
| +1 | K222516 | Mercury® II Spinal System | Spinal Elements, Inc. | 2022 | — |
| +2 | K243916 | Primus Spinal Fixation System | Spinal Elements, Inc. | 2025 | — |
| +3 | K251154 | RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation… | Ht Medical D.B.A. Xenix Medical | 2025 | — |
| +4 | K262193 | RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA®… | Xenix Medical | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 2 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 4 | 0 |
| 1995 | 7 | 0 |
| 1996 | 2 | 0 |
| 1997 | 5 | 0 |
| 1998 | 6 | 0 |
| 1999 | 3 | 0 |
| 2000 | 11 | 0 |
| 2001 | 9 | 0 |
| 2002 | 8 | 0 |
| 2003 | 8 | 0 |
| 2004 | 19 | 0 |
| 2005 | 14 | 0 |
| 2006 | 8 | 0 |
| 2007 | 3 | 0 |
| 2008 | 5 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 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? (3)
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 |
|---|---|---|---|
| * | K140454 | Navigated CD Horizon Solera Screwdriver/TapsSummary page 5…Premarket Notification Substantial Equivalence The subject devices are substantially equivalent to the primary predicate devices cleared in K140454 and the additional predicates cleared in K143375 and K143628. Technological Characteristics The subject device has equivalent te… | 2014 |
| * | K143375 | CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsSummary page 5…Substantial Equivalence The subject devices are substantially equivalent to the primary predicate devices cleared in K140454 and the additional predicates cleared in K143375 and K143628. Technological Characteristics The subject device has equivalent technological characteristics to its predicates pre… | 2015 |
| * | K143628 | Navigated Vertex Select InstrumentsSummary page 5…ial Equivalence The subject devices are substantially equivalent to the primary predicate devices cleared in K140454 and the additional predicates cleared in K143375 and K143628. Technological Characteristics The subject device has equivalent technological characteristics to its predicates presented below… | 2015 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222516 | Mercury® II Spinal System | 2022 | 3 |
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 15 years and passes through 4 companies; a new generation was cleared every 5 months on median.
- 21 of the 152 ancestors have a recall of any class.
- Of its descendants, K222516 (Spinal Elements, Inc., 2022) has gone furthest, with 3 descendants of its own.
- 48 other devices also cite its predicate K140454.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
Spinal Elements Navigated Instruments are intended to be used during the preparation and placement of Spinal Elements screws (Overwatch®, Savannah® and Mercury® Fixation Systems) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190881 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190881: Spinal Elements Navigated Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190881
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