510(k) · Cleared
Recalled · Class II · 2026Innovasis Navigation Instruments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innovasis, Inc. · OLO Orthopedic Stereotaxic Instrument
Cleared on Mar 24, 2025 as substantially equivalent to K223511 (Innovasis, Inc., 2023) and 2 other predicates after a 61-day review. Its family tree reaches back 18 generations to 2004. 2 later devices descend from it. It has been recalled once.
- Decided
- Mar 24, 2025
- Review
- 61 days
- Class
- Class II
- Product code
- OLO
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 18 generations to K040583 (2004). 156 ancestors in all, the oldest K841189 (1984). 2 later devices descend from it, 2 citing it directly.
- Root · 18 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 14 generations between
- 3 generations backK143019 CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc. · 2015
- 2 generations backK153463 CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc. · 2015
- 1 generation backK170679 CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use…Medtronic Sofamor Danek · 2017
- This deviceK250182 Innovasis Navigation InstrumentsInnovasis, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK252962 DYNAMIS™ Navigation SystemPromethean Restorative, LLC · 2026
- Descendant · cites it directly · 0 of its ownK251073 Innovasis Navigation Instruments (Vector G-E Navigation Instruments…Innovasis, Inc. · 2025 · Recalled
Show all 18 generations
- Root · 18 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 17 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 16 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 15 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 14 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 13 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 12 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 11 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 10 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 9 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 8 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 7 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 6 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 5 generations backK122862 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 4 generations backK141605 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014
- 3 generations backK143019 CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc. · 2015
- 2 generations backK153463 CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc. · 2015
- 1 generation backK170679 CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use…Medtronic Sofamor Danek · 2017
- This deviceK250182 Innovasis Navigation InstrumentsInnovasis, Inc. · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −17 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −16 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −15 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −14 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −13 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −12 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −11 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −10 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −9 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −8 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −7 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −6 | K121680 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| −5 | K122862 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| −4 | K141605 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2014 | — |
| −3 | K143019 | CD HORIZON Spinal System, IPC POWEREASE System | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| −2 | K153463 | CD HORIZON Spinal System, IPC POWEREASE System | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| −1 | K170679 | CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the… | Medtronic Sofamor Danek | 2017 | — |
| 0 (this device) | K250182 | Innovasis Navigation Instruments | Innovasis, Inc. | 2025 | — |
| +1 | K252962 | DYNAMIS™ Navigation System | Promethean Restorative, LLC | 2026 | — |
| +1 | K251073 | Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the… | Innovasis, Inc. | 2025 | 1 |
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 | 3 | 0 |
| 2015 | 1 | 0 |
| 2023 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 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 |
|---|---|---|---|
| * | K223511 | Excella Navigation InstrumentsSummary page 6…ure Geometry • Sterility Predicate Devices 510k Number Trade or Proprietary or Model Name Manufacturer Predicate Type K223511 Excella Navigation Instruments Innovasis, Inc. Primary K170679/K140454 Naviga… | 2023 |
| * | K170679 | CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC®…Summary page 6…Manufacturer Predicate Type K223511 Excella Navigation Instruments Innovasis, Inc. Primary K170679/K140454 Navigated CD HORIZON® SOLERA® Medtronic Sofamor Danek, USA Inc. Additional Scr… | 2017 |
| * | K140454 | Navigated CD Horizon Solera Screwdriver/TapsSummary page 6…cturer Predicate Type K223511 Excella Navigation Instruments Innovasis, Inc. Primary K170679/K140454 Navigated CD HORIZON® SOLERA® Medtronic Sofamor Danek, USA Inc. Additional Screwdriver… | 2014 |
What descends from it? (2)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 22, 2026 | Class II | Z-2859-2026 | Process design | Pedicle screw system intended to provide immobilization/stabilization of spinal segments as adjunct to thoracic/lumbar/sacral spine fusion may have anti-torque instrument with undersized condition which could prevent mating tip from… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 7 months on median.
- 21 of the 156 ancestors have a recall of any class.
- Of its descendants, K252962 (Promethean Restorative, LLC, 2026) has gone furthest, with 0 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. 2025, 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 Innovasis Navigation Instruments are intended to be used in the preparation and placement of Innovasis Screws 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 S7 and StealthStation System S8, 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K250182 · printed Nov 4, 2026
Cite this page
510(k) Report. “K250182: Innovasis Navigation Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K250182
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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