510(k) · Cleared
ClearedNavigation Enabled Intruments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medos International SARL · OLO Orthopedic Stereotaxic Instrument
Cleared on Jul 31, 2020 as substantially equivalent to K140454 (Medtronic Sofamor Danek USA, Inc., 2014) and 1 other predicate after a 127-day review. Its family tree reaches back 12 generations to 1986. 5 later devices descend from it.
- Decided
- Jul 31, 2020
- Review
- 127 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). 5 later devices descend from it, 3 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 deviceK200791 Navigation Enabled IntrumentsMedos International SARL · 2020
- Descendant · cites it directly · 3 of its ownK231527 TriALTIS Navigation Enabled InstrumentsMedos International Sàrl · 2023
- Descendant · cites it directly · 2 of its ownK233255 CROSSNAV Navigation Enabled InstrumentsDePuy Synthes · 2024
- Descendant · 2 generations on · 1 of its ownK241893 CROSSNAV Navigation Enabled Instruments and UNAS Navigation ArraysMedos International SARL · 2024
- Descendant · 3 generations on · 0 of its ownK254157 CROSSNAV Navigation Enabled Instruments for Disc Preparation and…Medos International SARL · 2026
- Descendant · cites it directly · 0 of its ownK233256 Robotic Integration InstrumentsDePuy Synthes · 2024
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 deviceK200791 Navigation Enabled IntrumentsMedos International SARL · 2020
Most influential descendants
Showing 5 of 5 · See all- K231527TriALTIS Navigation Enabled InstrumentsMedos International Sàrl · 2023 · cites it directly3descendants
- K233255CROSSNAV Navigation Enabled InstrumentsDePuy Synthes · 2024 · cites it directly2descendants
- K241893CROSSNAV Navigation Enabled Instruments and UNAS Navigation ArraysMedos International SARL · 2024 · 2 generations on1descendant
- K254157CROSSNAV Navigation Enabled Instruments for Disc Preparation and InterbodyMedos International SARL · 2026 · 3 generations on0descendants
- K233256Robotic Integration InstrumentsDePuy Synthes · 2024 · cites it directly0descendants
View 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) | K200791 | Navigation Enabled Intruments | Medos International SARL | 2020 | — |
| +1 | K231527 | TriALTIS Navigation Enabled Instruments | Medos International Sàrl | 2023 | — |
| +1 | K233255 | CROSSNAV Navigation Enabled Instruments | DePuy Synthes | 2024 | — |
| +2 | K241893 | CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays | Medos International SARL | 2024 | — |
| +3 | K254157 | CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody | Medos International SARL | 2026 | — |
| +1 | K233256 | Robotic Integration Instruments | DePuy Synthes | 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 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 3 | 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? (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 |
|---|---|---|---|
| * | K140454 | Navigated CD Horizon Solera Screwdriver/TapsSummary page 4…duct and OLO; Orthopedic Panel Code: D. Predicate Device Names Primary Predicate Device: Navigated CD HORIZON® SOLERA® Screwdrivers and Taps (K140454) Secondary Predicate Device: Navigated INFINITY™ Instruments (K173338) Reference Devices: Medtronic Stealth… | 2014 |
| * | K173338 | Navigated INFINITY™ InstrumentsSummary page 4…Primary Predicate Device: Navigated CD HORIZON® SOLERA® Screwdrivers and Taps (K140454) Secondary Predicate Device: Navigated INFINITY™ Instruments (K173338) Reference Devices: Medtronic StealthStation S8 Spine Hardware and Software (K162309 and K170011)… | 2018 |
| † | K162309 | StealthStation S8 System Platforms and StealthStation Cranial Software | 2017 |
| † | K170011 | StealthStation S8 Spine Software v1.0.0 | 2017 |
| † | K111136 | Expedium Spine System, Viper System, Viper 2 System | 2012 |
| † | K142185 | Expedium Verse Spine System | 2014 |
| † | K160904 | Expedium Spine System, VIPER and VIPER 2 Systems | 2016 |
| † | K181949 | SYMPHONY™ OCT System | 2018 |
What descends from it? (5)
3 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 34 years and passes through 6 companies; a new generation was cleared every 2.2 years on median.
- 10 of the 65 ancestors have a recall of any class.
- Of its descendants, K231527 (Medos International Sàrl, 2023) 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. 2020, 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?
Navigation Enabled Instruments are reusable instruments intended to be used during the preparation and placement of DePuy Synthes screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or percutaneous procedures. The Navigation Enabled Instruments are designed for use with only the specific DePuy Synthes implant system(s) for which they are intended; and with the Medtronic StealthStation® System. The…
Read the full statement (210 words)
Navigation Enabled Instruments are reusable instruments intended to be used during the preparation and placement of DePuy Synthes screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or percutaneous procedures. The Navigation Enabled Instruments are designed for use with only the specific DePuy Synthes implant system(s) for which they are intended; and with the Medtronic StealthStation® System. The Navigation Enabled Instruments are indicated for use in surgical spinal procedures, in which:
• the use of EXPEDIUM® 4.5, EXPEDIUM® 5.5, EXPEDIUM® 6.35, VIPER® 2, VIPER® SAI, EXPEDIUM VERSE®, VIPER PRIME® (without stylet control) or SYMPHONYTM OCT system is indicated,
• the use of stereotactic surgery may be appropriate, and
• reference to a rigid anatomical structure, such as the pelvis or a vertebrae can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy.
These procedures include but are not limited to spinal fusion. The Navigation Enabled Instruments are also compatible with Synthes Small Battery Drive II System and the Medtronic IPC® POWEREASE System.
The Navigation Enabled Instruments used in conjunction with the SYMPHONY OCT system are intended to support indicated cervical and thoracic polyaxial screw placement only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200791 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200791: Navigation Enabled Intruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200791
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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