510(k) · Cleared
Recalled · Class II · 2019NavLock Trackers, Robotic Reference Frame
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Navigation · OLO Orthopedic Stereotaxic Instrument
Cleared on Nov 2, 2018 as substantially equivalent to K171267 (Medtronic Navigation, 2017) after a 91-day review. Its family tree reaches back 10 generations to 1986. 3 later devices descend from it. It has been recalled once.
- Decided
- Nov 2, 2018
- Review
- 91 days
- Class
- Class II
- Product code
- OLO
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 10 generations to K862807 (1986). 62 ancestors in all, the oldest K842956 (1984). 3 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK862807 Treace Drill SystemTreace Medical, Inc. · 1986
- 6 generations between
- 3 generations backK111520 Ipc Powerease SystemMedtronic Xomed, Inc. · 2011 · Recalled
- 2 generations backK124004 Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy…Medtronic Navigation, Inc. · 2013 · Recalled
- 1 generation backK171267 NavLock TrackersMedtronic Navigation · 2017 · Recalled
- This deviceK182104 NavLock Trackers, Robotic Reference FrameMedtronic Navigation · 2018
- Descendant · cites it directly · 2 of its ownK201327 NavLock TrackersMedtronic Navigation · 2020
- Descendant · 2 generations on · 0 of its ownK252989 “POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories SetPoint Robotics MedTech, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK232800 Navigation Tracking InstrumentsSI-BONE, Inc. · 2024
Show all 10 generations
- Root · 10 generations backK862807 Treace Drill SystemTreace Medical, Inc. · 1986
- 9 generations backK964548 Apex Universal Drive SystemLinvatec Corp. · 1997
- 8 generations backK971059 Universal Drive SystemLinvatec Corp. · 1997
- 7 generations backK981637 Integrated Drive/Pump System for OtolaryngologyLinvatec Corp. · 1998
- 6 generations backK990524 E9000 SystemLinvatec Corp. · 1999
- 5 generations backK012456 Sodem High Speed System (Electric) (Ear, Nose, and Throat)Sodemsystems · 2001
- 4 generations backK081277 XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power…Medtronic Xomed, Inc. · 2008 · Recalled
- 3 generations backK111520 Ipc Powerease SystemMedtronic Xomed, Inc. · 2011 · Recalled
- 2 generations backK124004 Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy…Medtronic Navigation, Inc. · 2013 · Recalled
- 1 generation backK171267 NavLock TrackersMedtronic Navigation · 2017 · Recalled
- This deviceK182104 NavLock Trackers, Robotic Reference FrameMedtronic Navigation · 2018
Most influential descendants
Showing 3 of 3 · See all- K201327NavLock TrackersMedtronic Navigation · 2020 · cites it directly2descendants
- K252989“POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories SetPoint Robotics MedTech, Inc. · 2026 · 2 generations on0descendants
- K232800Navigation Tracking InstrumentsSI-BONE, Inc. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K862807 | Treace Drill System | Treace Medical, Inc. | 1986 | — |
| −9 | K964548 | Apex Universal Drive System | Linvatec Corp. | 1997 | — |
| −8 | K971059 | Universal Drive System | Linvatec Corp. | 1997 | — |
| −7 | K981637 | Integrated Drive/Pump System for Otolaryngology | Linvatec Corp. | 1998 | — |
| −6 | K990524 | E9000 System | Linvatec Corp. | 1999 | — |
| −5 | K012456 | Sodem High Speed System (Electric) (Ear, Nose, and Throat) | Sodemsystems | 2001 | — |
| −4 | K081277 | XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power CONS0LE (Ipc) | Medtronic Xomed, Inc. | 2008 | 1 |
| −3 | K111520 | Ipc Powerease System | Medtronic Xomed, Inc. | 2011 | 2 |
| −2 | K124004 | Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy Taps | Medtronic Navigation, Inc. | 2013 | 1 |
| −1 | K171267 | NavLock Trackers | Medtronic Navigation | 2017 | 1 |
| 0 (this device) | K182104 | NavLock Trackers, Robotic Reference Frame | Medtronic Navigation | 2018 | — |
| +1 | K201327 | NavLock Trackers | Medtronic Navigation | 2020 | — |
| +2 | K252989 | “POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories Set | Point Robotics MedTech, Inc. | 2026 | — |
| +2 | K232800 | Navigation Tracking Instruments | SI-BONE, Inc. | 2024 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2024 | 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? (1)
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 |
|---|---|---|---|
| * | K171267 | NavLock TrackersSummary page 6…terbody procedures that utilize the MAZOR X Stealth™ Edition system. IX. Identification of Legally Marketed Devices (Predicate Devices): NavLock Trackers (K171267, S.E. 07/03/2017). This predicate has not been subject to any recall. This predicate is the primary predicate for this subm… | 2017 |
| † | K170011 | StealthStation S8 Spine Software v1.0.0 | 2017 |
| † | K162309 | StealthStation S8 System Platforms and StealthStation Cranial Software | 2017 |
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 |
|---|---|---|---|
| K201327 | NavLock Trackers | 2020 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 28, 2019 | Class II | Z-1693-2020 | Employee error | Product was incorrectly assembled which could affect navigation accuracy of the 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 6 companies; a new generation was cleared every 2.2 years on median.
- 10 of the 62 ancestors have a recall of any class.
- Of its descendants, K201327 (Medtronic Navigation, 2020) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K171267.
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?
The NavLock™ Trackers are intended to enable navigation of Medtronic instrumentation used during spinal fusion and interbody procedures with the MAZOR X Stealth™ Edition system. The NavLock™ Trackers should only be used with Medtronic instruments on the MAZOR X Stealth™ Edition system.
The Robotic Reference Frame is an accessory to the MAZOR X Stealth Edition system and is intended to enable navigation during spinal fusion and interbody procedures that utilize the MAZOR X Stealth Edition system
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182104 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182104: NavLock Trackers, Robotic Reference Frame.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182104
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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