510(k) · Cleared
ClearedCROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays
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 Sep 16, 2024 as substantially equivalent to K233255 (DePuy Synthes, 2024) and 3 other predicates after an 80-day review. Its family tree reaches back 15 generations to 1986. 3 of the 109 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- Sep 16, 2024
- Review
- 80 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 15 generations to K862807 (1986). 107 ancestors in all, the oldest K842956 (1984). 1 later device descends from it, 1 citing it directly. 3 of the 109 devices in this family, counting this one, have a Class I recall.
- Root · 15 generations backK862807 Treace Drill SystemTreace Medical, Inc. · 1986
- 11 generations between
- 3 generations backK200791 Navigation Enabled IntrumentsMedos International SARL · 2020
- 2 generations backK231527 TriALTIS Navigation Enabled InstrumentsMedos International Sàrl · 2023
- 1 generation backK233255 CROSSNAV Navigation Enabled InstrumentsDePuy Synthes · 2024
- This deviceK241893 CROSSNAV Navigation Enabled Instruments and UNAS Navigation ArraysMedos International SARL · 2024
- Descendant · cites it directly · 0 of its ownK254157 CROSSNAV Navigation Enabled Instruments for Disc Preparation and…Medos International SARL · 2026
Show all 15 generations
- Root · 15 generations backK862807 Treace Drill SystemTreace Medical, Inc. · 1986
- 14 generations backK964548 Apex Universal Drive SystemLinvatec Corp. · 1997
- 13 generations backK971059 Universal Drive SystemLinvatec Corp. · 1997
- 12 generations backK981637 Integrated Drive/Pump System for OtolaryngologyLinvatec Corp. · 1998
- 11 generations backK990524 E9000 SystemLinvatec Corp. · 1999
- 10 generations backK012456 Sodem High Speed System (Electric) (Ear, Nose, and Throat)Sodemsystems · 2001
- 9 generations backK081277 XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power…Medtronic Xomed, Inc. · 2008 · Recalled
- 8 generations backK111520 Ipc Powerease SystemMedtronic Xomed, Inc. · 2011 · Recalled
- 7 generations backK123270 Powerease SystemMedtronic Sofamor Danek USA, Inc. · 2013
- 6 generations backK140454 Navigated CD Horizon Solera Screwdriver/TapsMedtronic Sofamor Danek USA, Inc. · 2014 · Recalled
- 5 generations backK143628 Navigated Vertex Select InstrumentsMedtronic Sofamor Danek USA, Inc. · 2015
- 4 generations backK173338 Navigated INFINITY™ InstrumentsMedtronic Sofamor Danek USA, Inc. · 2018
- 3 generations backK200791 Navigation Enabled IntrumentsMedos International SARL · 2020
- 2 generations backK231527 TriALTIS Navigation Enabled InstrumentsMedos International Sàrl · 2023
- 1 generation backK233255 CROSSNAV Navigation Enabled InstrumentsDePuy Synthes · 2024
- This deviceK241893 CROSSNAV Navigation Enabled Instruments and UNAS Navigation ArraysMedos International SARL · 2024
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K254157CROSSNAV Navigation Enabled Instruments for Disc Preparation and InterbodyMedos International SARL · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K862807 | Treace Drill System | Treace Medical, Inc. | 1986 | — |
| −14 | K964548 | Apex Universal Drive System | Linvatec Corp. | 1997 | — |
| −13 | K971059 | Universal Drive System | Linvatec Corp. | 1997 | — |
| −12 | K981637 | Integrated Drive/Pump System for Otolaryngology | Linvatec Corp. | 1998 | — |
| −11 | K990524 | E9000 System | Linvatec Corp. | 1999 | — |
| −10 | K012456 | Sodem High Speed System (Electric) (Ear, Nose, and Throat) | Sodemsystems | 2001 | — |
| −9 | K081277 | XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power CONS0LE (Ipc) | Medtronic Xomed, Inc. | 2008 | 1 |
| −8 | K111520 | Ipc Powerease System | Medtronic Xomed, Inc. | 2011 | 2 |
| −7 | K123270 | Powerease System | Medtronic Sofamor Danek USA, Inc. | 2013 | — |
| −6 | K140454 | Navigated CD Horizon Solera Screwdriver/Taps | Medtronic Sofamor Danek USA, Inc. | 2014 | 1 |
| −5 | K143628 | Navigated Vertex Select Instruments | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| −4 | K173338 | Navigated INFINITY™ Instruments | Medtronic Sofamor Danek USA, Inc. | 2018 | — |
| −3 | K200791 | Navigation Enabled Intruments | Medos International SARL | 2020 | — |
| −2 | K231527 | TriALTIS Navigation Enabled Instruments | Medos International Sàrl | 2023 | — |
| −1 | K233255 | CROSSNAV Navigation Enabled Instruments | DePuy Synthes | 2024 | — |
| 0 (this device) | K241893 | CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays | Medos International SARL | 2024 | — |
| +1 | K254157 | CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody | Medos International SARL | 2026 | — |
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 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 6 | 0 |
| 2001 | 7 | 0 |
| 2002 | 7 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 6 | 0 |
| 2006 | 6 | 0 |
| 2007 | 3 | 1 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 1 |
| 2016 | 1 | 1 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
3 devices in this family have a Class I recall. 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? (4)
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 |
|---|---|---|---|
| * | K233255 | CROSSNAV Navigation Enabled InstrumentsSummary page 6…Panel Code: OLO – Orthopedic D. Predicate Device Names Primary Predicate Device: CROSSNAV Navigation Enabled Instruments (K233255) – OLO Additional Predicate Devices: UNAS Navigation Arrays (K201661) – OLO Brainlab Navigation System (K221618)… | 2024 |
| * | K201661 | Symphony Navigation Ready Instruments and Universal Navigation Adaptor SetSummary page 6…ice Names Primary Predicate Device: CROSSNAV Navigation Enabled Instruments (K233255) – OLO Additional Predicate Devices: UNAS Navigation Arrays (K201661) – OLO Brainlab Navigation System (K221618) – OLO UNAS Navigation Rings (K233254) – OLO… | 2020 |
| * | K221618 | Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma…Summary page 6…CROSSNAV Navigation Enabled Instruments (K233255) – OLO Additional Predicate Devices: UNAS Navigation Arrays (K201661) – OLO Brainlab Navigation System (K221618) – OLO UNAS Navigation Rings (K233254) – OLO Page 1 of 4… | 2022 |
| * | K233254 | TELIGEN System Navigation Ready InstrumentsSummary page 6…33255) – OLO Additional Predicate Devices: UNAS Navigation Arrays (K201661) – OLO Brainlab Navigation System (K221618) – OLO UNAS Navigation Rings (K233254) – OLO Page 1 of 4… | 2024 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K254157 | CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody | 2026 | 0 |
Has anything in its family been recalled? (3 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K070106VV Fluoro 3DBrainlab AG · 2007 · 3 generations back · ◆ in the 2007 ancestors bar of FIG. 11 Class I recall
- K153660StealthStation System with Cranial SoftwareMedtronic Navigation, Inc. · 2016 · 4 generations back · ◆ in the 2016 ancestors bar of FIG. 13 Class I recalls
- K150216Synergy CranialMedtronic Navigation, Inc. · 2015 · 5 generations back · ◆ in the 2015 ancestors bar of FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 38 years and passes through 8 companies; a new generation was cleared every 1.4 years on median.
- 18 of the 107 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K254157 (Medos International SARL, 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. 2024, 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 indicated 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 indicated and with the VELYS Spine System as well as with…
Read the full statement (395 words)
Navigation Enabled Instruments are reusable instruments indicated 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 indicated and with the VELYS Spine System as well as with the Brainlab Navigation System and the Medtronic StealthStation@ Navigation System. The Navigation Enabled Instruments are indicated for use in surgical spinal procedures, in which:
* the use of EXPEDIUMTm, VIPERm, SYMPHONYm OCT and the TriALTISTM Spine System is indicated,
* the use of stereotactic surgery may be appropriate, and
* reference to a rigid anatomical structure, such as the pelvis or a vertebra, can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 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 DePuy Synthes Power Systems 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.
The Universal Navigation Adaptor Set (UNAS) is intended for use with the compatible DePuy Synthes Navigation Ready Instruments to assist the surgeon in locating anatomical structures in either open or percutaneous procedures. These are indicated for use in surgical spinal procedures, in which:
* 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 fluoroscopic image reconstruction) and/or an image data based model of the anatomy using a navigation system and associated tracking arrays.
These procedures include but are not limited to spinal fusion. The DePuy Synthes Navigation Ready Instruments, when used with UNAS, can be:
* pre-calibrated with the VELYS Spine System using VELYS Spine Instrument Arrays,
* pre-calibrated and/or manually calibrated with the Brainlab Navigation System,
where other navigation systems require manual calibration and tracking arrays supplied by the navigation system manufacturer.
Via the CROSSNAV Adaptor, the UNAS Navigation Arrays are also compatible with DePuy Synthes Navigation Enabled Instruments indicated for use with the Brainlab Navigation System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241893 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241893: CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241893
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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