510(k) · Cleared
ClearedUniversal Navigation Instruments
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 Oct 24, 2014 as substantially equivalent to K120867 (Medos International SARL, 2012) and 3 other predicates after a 196-day review. Its family tree reaches back 6 generations to 1999. 1 of the 16 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Oct 24, 2014
- Review
- 196 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K983831 (1999). 14 ancestors in all, the oldest K981508 (1998). 1 later device descends from it, 1 citing it directly. 1 of the 16 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 5 generations backK014256 Kolibri Igs SystemsBrainlab AG · 2002
- 4 generations backK042721 Kolibri SpineBrainlab AG · 2005
- 3 generations backK053159 Vectorvision SpineBrainlab AG · 2006 · Recalled
- 2 generations backK070106 VV Fluoro 3DBrainlab AG · 2007 · Recalled (Class I)
- 1 generation backK120867 Viper and Expedium Navigated InstrumentsMedos International SARL · 2012
- This deviceK140927 Universal Navigation InstrumentsMedos International SARL · 2014
- Descendant · cites it directly · 0 of its ownK192495 Black Diamond Navigation InstrumentsOsseus Fusion Systems · 2020
Class I recalls in this family
- K070106 VV Fluoro 3Ddirect predicate · 2007
Most influential descendants
Showing 1 of 1 · See all- K192495Black Diamond Navigation InstrumentsOsseus Fusion Systems · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K983831 | VECTORVISION2 | Brainlab AG | 1999 | — |
| −5 | K014256 | Kolibri Igs Systems | Brainlab AG | 2002 | — |
| −4 | K042721 | Kolibri Spine | Brainlab AG | 2005 | — |
| −3 | K053159 | Vectorvision Spine | Brainlab AG | 2006 | 1 |
| −2 | K070106 | VV Fluoro 3D | Brainlab AG | 2007 | Class I |
| −1 | K120867 | Viper and Expedium Navigated Instruments | Medos International SARL | 2012 | — |
| 0 (this device) | K140927 | Universal Navigation Instruments | Medos International SARL | 2014 | — |
| +1 | K192495 | Black Diamond Navigation Instruments | Osseus Fusion Systems | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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.
1 device in this family has 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 |
|---|---|---|---|
| * | K120867 | Viper and Expedium Navigated InstrumentsSummary page 4…21 CFR §882.4560 OLO; Orthopedic D. Predicate Device Name Trade name: EXPEDIUM and VIPER Navigated Instruments (K120867) Synthes Navigable Pedicle Preparation Instruments (K122211)… | 2012 |
| * | K122211 | Synthes Navigable Pedicle Preparation InstrumentsSummary page 4…EXPEDIUM and VIPER Navigated Instruments (K120867) Synthes Navigable Pedicle Preparation Instruments (K122211) Brainlab VectorVision Fluoro 3D System (K070106) Medtronic Steal… | 2012 |
| * | K070106 | VV Fluoro 3DSummary page 4…Synthes Navigable Pedicle Preparation Instruments (K122211) Brainlab VectorVision Fluoro 3D System (K070106) Medtronic StealthStation (K050438)… | 2007 |
| * | K050438 | Stealthstation System UpdateSummary page 4…(K122211) Brainlab VectorVision Fluoro 3D System (K070106) Medtronic StealthStation (K050438) K140927, Page 2 of 3 E. Device… | 2005 |
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 |
|---|---|---|---|
| K192495 | Black Diamond Navigation Instruments | 2020 | 0 |
Has anything in its family been recalled? (1 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 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 2.8 years on median.
- 4 of the 14 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K192495 (Osseus Fusion Systems, 2020) 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. 2014, 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 Universal Navigation Instruments for EXPEDIUM® and VIPER® MIS Spine Systems are intended to assist the surgeon in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures. These are indicated for use in surgical spinal procedures, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis or a vertebrae can be identified relative…
Read the full statement (128 words)
The Universal Navigation Instruments for EXPEDIUM® and VIPER® MIS Spine Systems are intended to assist the surgeon in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures. These are indicated for use in surgical spinal procedures, in which the use of stereotactic surgery may be appropriate, and where 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 using tracking arrays provided by the navigation manufacturer. These procedures include but are not limited to spinal fusion. These devices can be pre-calibrated and/or manually calibrated with Brainlab Navigation system, where other navigation systems require manual calibration.
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/K140927 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140927: Universal Navigation Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140927
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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