510(k) · Cleared
ClearedCROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody
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 May 26, 2026 as substantially equivalent to K251282 (Medtronic Navigation, Inc., 2025) and 1 other predicate after a 155-day review. Its family tree reaches back 16 generations to 1986. 3 of the 111 devices in its family, counting itself, have a Class I recall.
- Decided
- May 26, 2026
- Review
- 155 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 16 generations to K862807 (1986). 110 ancestors in all, the oldest K842956 (1984). No later device cites it as a predicate yet. 3 of the 111 devices in this family, counting this one, have a Class I recall.
- Root · 16 generations backK862807 Treace Drill SystemTreace Medical, Inc. · 1986
- 12 generations between
- 3 generations backK231527 TriALTIS Navigation Enabled InstrumentsMedos International Sàrl · 2023
- 2 generations backK233255 CROSSNAV Navigation Enabled InstrumentsDePuy Synthes · 2024
- 1 generation backK241893 CROSSNAV Navigation Enabled Instruments and UNAS Navigation ArraysMedos International SARL · 2024
- This deviceK254157 CROSSNAV Navigation Enabled Instruments for Disc Preparation and…Medos International SARL · 2026
Show all 16 generations
- Root · 16 generations backK862807 Treace Drill SystemTreace Medical, Inc. · 1986
- 15 generations backK964548 Apex Universal Drive SystemLinvatec Corp. · 1997
- 14 generations backK971059 Universal Drive SystemLinvatec Corp. · 1997
- 13 generations backK981637 Integrated Drive/Pump System for OtolaryngologyLinvatec Corp. · 1998
- 12 generations backK990524 E9000 SystemLinvatec Corp. · 1999
- 11 generations backK012456 Sodem High Speed System (Electric) (Ear, Nose, and Throat)Sodemsystems · 2001
- 10 generations backK081277 XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power…Medtronic Xomed, Inc. · 2008 · Recalled
- 9 generations backK111520 Ipc Powerease SystemMedtronic Xomed, Inc. · 2011 · Recalled
- 8 generations backK123270 Powerease SystemMedtronic Sofamor Danek USA, Inc. · 2013
- 7 generations backK140454 Navigated CD Horizon Solera Screwdriver/TapsMedtronic Sofamor Danek USA, Inc. · 2014 · Recalled
- 6 generations backK143628 Navigated Vertex Select InstrumentsMedtronic Sofamor Danek USA, Inc. · 2015
- 5 generations backK173338 Navigated INFINITY™ InstrumentsMedtronic Sofamor Danek USA, Inc. · 2018
- 4 generations backK200791 Navigation Enabled IntrumentsMedos International SARL · 2020
- 3 generations backK231527 TriALTIS Navigation Enabled InstrumentsMedos International Sàrl · 2023
- 2 generations backK233255 CROSSNAV Navigation Enabled InstrumentsDePuy Synthes · 2024
- 1 generation backK241893 CROSSNAV Navigation Enabled Instruments and UNAS Navigation ArraysMedos International SARL · 2024
- This deviceK254157 CROSSNAV Navigation Enabled Instruments for Disc Preparation and…Medos International SARL · 2026
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K862807 | Treace Drill System | Treace Medical, Inc. | 1986 | — |
| −15 | K964548 | Apex Universal Drive System | Linvatec Corp. | 1997 | — |
| −14 | K971059 | Universal Drive System | Linvatec Corp. | 1997 | — |
| −13 | K981637 | Integrated Drive/Pump System for Otolaryngology | Linvatec Corp. | 1998 | — |
| −12 | K990524 | E9000 System | Linvatec Corp. | 1999 | — |
| −11 | K012456 | Sodem High Speed System (Electric) (Ear, Nose, and Throat) | Sodemsystems | 2001 | — |
| −10 | K081277 | XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power CONS0LE (Ipc) | Medtronic Xomed, Inc. | 2008 | 1 |
| −9 | K111520 | Ipc Powerease System | Medtronic Xomed, Inc. | 2011 | 2 |
| −8 | K123270 | Powerease System | Medtronic Sofamor Danek USA, Inc. | 2013 | — |
| −7 | K140454 | Navigated CD Horizon Solera Screwdriver/Taps | Medtronic Sofamor Danek USA, Inc. | 2014 | 1 |
| −6 | K143628 | Navigated Vertex Select Instruments | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| −5 | K173338 | Navigated INFINITY™ Instruments | Medtronic Sofamor Danek USA, Inc. | 2018 | — |
| −4 | K200791 | Navigation Enabled Intruments | Medos International SARL | 2020 | — |
| −3 | K231527 | TriALTIS Navigation Enabled Instruments | Medos International Sàrl | 2023 | — |
| −2 | K233255 | CROSSNAV Navigation Enabled Instruments | DePuy Synthes | 2024 | — |
| −1 | K241893 | CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays | Medos International SARL | 2024 | — |
| 0 (this device) | 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 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K251282 | StealthStation S8 Spine SoftwareSummary page 5…21 CFR §882.4560 Product Code: OLO D. Predicate Device Names Primary Predicate Device: StealthStation S8 Spine Software (K251282) – OLO Additional Predicate Device: CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays (K241893) – OLO… | 2025 |
| * | K241893 | CROSSNAV Navigation Enabled Instruments and UNAS Navigation ArraysSummary page 5…Device: StealthStation S8 Spine Software (K251282) – OLO Additional Predicate Device: CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays (K241893) – OLO Page 1 of 3… | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
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.
- K153660StealthStation System with Cranial SoftwareMedtronic Navigation, Inc. · 2016 · 4 generations back · ◆ in the 2016 ancestors bar of FIG. 13 Class I recalls
- K070106VV Fluoro 3DBrainlab AG · 2007 · 4 generations back · ◆ in the 2007 ancestors bar of FIG. 11 Class I recall
- 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 40 years and passes through 8 companies; a new generation was cleared every 1.7 years on median.
- 19 of the 110 ancestors have a recall of any class; 3 have a Class I recall.
- 1 other device also cites its predicate K251282.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 implants as well as discectomy and / or bony resection, 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…
Read the full statement (253 words)
Navigation Enabled Instruments are reusable instruments indicated to be used during the preparation and placement of DePuy Synthes implants as well as discectomy and / or bony resection, 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 Navigation 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 EXPEDIUM™ VIPER™ SYMPHONY™ OCT, TriALTIS™, and the CONDUIT™ Spine System is indicated, if used for implant placement,
» 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 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 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 Navigation Enabled Instruments indicated for discectomy and / or bony resection, as well as the CONDUIT implants placement are for use with Medtronic StealthStation System only.
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/K254157 · printed Nov 6, 2026
Cite this page
510(k) Report. “K254157: CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K254157
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026