510(k) · Cleared
ClearedNavigated INFINITY Instruments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek USA, Inc. · OLO Orthopedic Stereotaxic Instrument
Cleared on May 17, 2018 as substantially equivalent to K173338 (Medtronic Sofamor Danek USA, Inc., 2018) and 1 other predicate after a 20-day review. Its family tree reaches back 12 generations to 1986. 2 later devices descend from it.
- Decided
- May 17, 2018
- Review
- 20 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K862807 (1986). 65 ancestors in all, the oldest K842956 (1984). 2 later devices descend from it, 2 citing it directly.
- Root · 12 generations backK862807 Treace Drill SystemTreace Medical, Inc. · 1986
- 8 generations between
- 3 generations backK140454 Navigated CD Horizon Solera Screwdriver/TapsMedtronic Sofamor Danek USA, Inc. · 2014 · Recalled
- 2 generations backK143628 Navigated Vertex Select InstrumentsMedtronic Sofamor Danek USA, Inc. · 2015
- 1 generation backK173338 Navigated INFINITY™ InstrumentsMedtronic Sofamor Danek USA, Inc. · 2018
- This deviceK181111 Navigated INFINITY InstrumentsMedtronic Sofamor Danek USA, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK231229 S-COMP Reform® POCT Navigation InstrumentsPrecision Spine, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK214059 CoreLink Navigation InstrumentsCorelink, LLC · 2022
Show all 12 generations
- Root · 12 generations backK862807 Treace Drill SystemTreace Medical, Inc. · 1986
- 11 generations backK964548 Apex Universal Drive SystemLinvatec Corp. · 1997
- 10 generations backK971059 Universal Drive SystemLinvatec Corp. · 1997
- 9 generations backK981637 Integrated Drive/Pump System for OtolaryngologyLinvatec Corp. · 1998
- 8 generations backK990524 E9000 SystemLinvatec Corp. · 1999
- 7 generations backK012456 Sodem High Speed System (Electric) (Ear, Nose, and Throat)Sodemsystems · 2001
- 6 generations backK081277 XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power…Medtronic Xomed, Inc. · 2008 · Recalled
- 5 generations backK111520 Ipc Powerease SystemMedtronic Xomed, Inc. · 2011 · Recalled
- 4 generations backK123270 Powerease SystemMedtronic Sofamor Danek USA, Inc. · 2013
- 3 generations backK140454 Navigated CD Horizon Solera Screwdriver/TapsMedtronic Sofamor Danek USA, Inc. · 2014 · Recalled
- 2 generations backK143628 Navigated Vertex Select InstrumentsMedtronic Sofamor Danek USA, Inc. · 2015
- 1 generation backK173338 Navigated INFINITY™ InstrumentsMedtronic Sofamor Danek USA, Inc. · 2018
- This deviceK181111 Navigated INFINITY InstrumentsMedtronic Sofamor Danek USA, Inc. · 2018
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 |
|---|---|---|---|---|---|
| −12 | K862807 | Treace Drill System | Treace Medical, Inc. | 1986 | — |
| −11 | K964548 | Apex Universal Drive System | Linvatec Corp. | 1997 | — |
| −10 | K971059 | Universal Drive System | Linvatec Corp. | 1997 | — |
| −9 | K981637 | Integrated Drive/Pump System for Otolaryngology | Linvatec Corp. | 1998 | — |
| −8 | K990524 | E9000 System | Linvatec Corp. | 1999 | — |
| −7 | K012456 | Sodem High Speed System (Electric) (Ear, Nose, and Throat) | Sodemsystems | 2001 | — |
| −6 | K081277 | XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power CONS0LE (Ipc) | Medtronic Xomed, Inc. | 2008 | 1 |
| −5 | K111520 | Ipc Powerease System | Medtronic Xomed, Inc. | 2011 | 2 |
| −4 | K123270 | Powerease System | Medtronic Sofamor Danek USA, Inc. | 2013 | — |
| −3 | K140454 | Navigated CD Horizon Solera Screwdriver/Taps | Medtronic Sofamor Danek USA, Inc. | 2014 | 1 |
| −2 | K143628 | Navigated Vertex Select Instruments | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| −1 | K173338 | Navigated INFINITY™ Instruments | Medtronic Sofamor Danek USA, Inc. | 2018 | — |
| 0 (this device) | K181111 | Navigated INFINITY Instruments | Medtronic Sofamor Danek USA, Inc. | 2018 | — |
| +1 | K231229 | S-COMP Reform® POCT Navigation Instruments | Precision Spine, Inc. | 2023 | — |
| +1 | K214059 | CoreLink Navigation Instruments | Corelink, LLC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 4 | 0 |
| 1995 | 7 | 0 |
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 5 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2008 | 2 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 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? (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 |
|---|---|---|---|
| * | K173338 | Navigated INFINITY™ InstrumentsSummary page 4…Drill Bit Classification: Class II Product Code: OLO III. Predicate Device: Primary Predicate: Navigated INFINITYTM Instruments (K173338, S.E. 01/18/2018) Additional Predicate: Navigated VERTEX SELECT® Instruments (K143628, S.E. 02/12/2015)… | 2018 |
| * | K143628 | Navigated Vertex Select InstrumentsSummary page 4…imary Predicate: Navigated INFINITYTM Instruments (K173338, S.E. 01/18/2018) Additional Predicate: Navigated VERTEX SELECT® Instruments (K143628, S.E. 02/12/2015) These predicates have not been subject to a design-related recall The following reference devic… | 2015 |
| † | K163375 | INFINITY™ OCT System | 2017 |
| † | K111520 | Ipc Powerease System | 2011 |
| † | K123270 | Powerease System | 2013 |
| † | K050438 | Stealthstation System Update | 2005 |
| † | K170011 | StealthStation S8 Spine Software v1.0.0 | 2017 |
| † | K124004 | Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy Taps | 2013 |
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)
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 32 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
- 10 of the 65 ancestors have a recall of any class.
- Of its descendants, K231229 (Precision Spine, Inc., 2023) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K173338.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
Medtronic Navigated Instruments are intended to be used during the preparation and placement of Medtronic screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, or minimally invasive, procedures. Medtronic Navigated Instruments are specifically designed for use with the StealthStation™ System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate…
Read the full statement (110 words)
Medtronic Navigated Instruments are intended to be used during the preparation and placement of Medtronic screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, or minimally invasive, procedures. Medtronic Navigated Instruments are specifically designed for use with the 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 a skull, a long bone, or vertebra can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. Medtronic Navigated Instruments are also compatible with the IPC™ POWEREASE™ System.
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/K181111 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181111: Navigated INFINITY Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181111
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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