510(k) · Cleared
ClearedSYMPHONY Navigation Ready Instruments, Universal Navigation Adaptor Set
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 18, 2019 as substantially equivalent to K122211 (Synthes Spine, 2012) after an 88-day review. Its family tree reaches back 6 generations to 1999. 1 of the 22 devices in its family, counting itself, has a Class I recall. 8 later devices descend from it.
- Decided
- Oct 18, 2019
- Review
- 88 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K983831 (1999). 13 ancestors in all, the oldest K981508 (1998). 8 later devices descend from it, 1 citing it directly. 1 of the 22 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 backK122211 Synthes Navigable Pedicle Preparation InstrumentsSynthes Spine · 2012
- This deviceK191943 SYMPHONY Navigation Ready Instruments, Universal Navigation Adaptor…Medos International SARL · 2019
- Descendant · cites it directly · 7 of its ownK201661 Symphony Navigation Ready Instruments and Universal Navigation…Medos International SARL · 2020
- Descendant · 2 generations on · 5 of its ownK212756 Discectomy Navigation Ready Instruments and Universal Navigation…Medos International SARL · 2022
- Descendant · 3 generations on · 4 of its ownK223108 TELIGEN System Navigation Ready Indications (TELIGEN Access Probe…Medos International SARL · 2023
- Descendant · 3 generations on · 2 of its ownK233254 TELIGEN System Navigation Ready InstrumentsDePuy Synthes · 2024
- Descendant · 2 generations on · 1 of its ownK241893 CROSSNAV Navigation Enabled Instruments and UNAS Navigation ArraysMedos International SARL · 2024
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K070106 VV Fluoro 3D2 generations back · 2007
Most influential descendants
Showing 5 of 8 · See all- K201661Symphony Navigation Ready Instruments and Universal Navigation Adaptor SetMedos International SARL · 2020 · cites it directly7descendants
- K212756Discectomy Navigation Ready Instruments and Universal Navigation Adaptor SetMedos International SARL · 2022 · 2 generations on5descendants
- K223108TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear)Medos International SARL · 2023 · 3 generations on4descendants
- K233254TELIGEN System Navigation Ready InstrumentsDePuy Synthes · 2024 · 3 generations on2descendants
- K241893CROSSNAV Navigation Enabled Instruments and UNAS Navigation ArraysMedos International SARL · 2024 · 2 generations on1descendant
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 | K122211 | Synthes Navigable Pedicle Preparation Instruments | Synthes Spine | 2012 | — |
| 0 (this device) | K191943 | SYMPHONY Navigation Ready Instruments, Universal Navigation Adaptor Set | Medos International SARL | 2019 | — |
| +1 | K201661 | Symphony Navigation Ready Instruments and Universal Navigation Adaptor Set | Medos International SARL | 2020 | — |
| +2 | K212756 | Discectomy Navigation Ready Instruments and Universal Navigation Adaptor Set | Medos International SARL | 2022 | — |
| +3 | K223108 | TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN… | Medos International SARL | 2023 | — |
| +3 | K233254 | TELIGEN System Navigation Ready Instruments | DePuy Synthes | 2024 | — |
| +2 | K241893 | CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays | Medos International SARL | 2024 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2026 | 2 | 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? (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 |
|---|---|---|---|
| * | K122211 | Synthes Navigable Pedicle Preparation InstrumentsSummary page 4…t and OLO; Orthopedic Panel Code: D. Predicate Device Names Primary Predicate Device: Synthes Navigable Pedicle Preparation (NPP) Instruments (K122211) Reference Device: Medtronic StealthStation® System (K133444)… | 2012 |
| † | K133444 | Stealthstation S7 / I7 / Fusion Navigation Systems, Axiem Navigation System | 2014 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201661 | Symphony Navigation Ready Instruments and Universal Navigation Adaptor Set | 2020 | 7 |
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 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 3.2 years on median.
- 4 of the 13 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K201661 (Medos International SARL, 2020) has gone furthest, with 7 descendants of its own.
- 7 other devices also cite its predicate K122211.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
SYMPHONY Navigation Ready Instruments: The SYMPHONY Navigation Ready Instruments when used with the compatible Universal Navigation Adaptor Set are intended 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 SYMPHONY OCT System is indicated, the use of stereotactic surgery may be appropriate, and reference to a rigid anatomical…
Read the full statement (291 words)
SYMPHONY Navigation Ready Instruments:
The SYMPHONY Navigation Ready Instruments when used with the compatible Universal Navigation Adaptor Set are intended 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 SYMPHONY OCT System is indicated,
the use of stereotactic surgery may be appropriate, and
reference to a rigid anatomical structure, such as 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 a navigation system which includes tracking arrays supplied by the navigation system manufacturer.
These procedures include but are not limited to spinal fusion. The SYMPHONY Navigation Ready Instruments require manual calibration with the Medtronic StealthStation navigation system.
The SYMPHONY Navigation Ready Instruments are intended to support cervical and thoracic polyaxial screw placement.
Universal Navigation Adaptor Set:
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 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy using a navigation system which includes tracking arrays supplied by the navigation system manufacturer.
These procedures include but are not limited to spinal fusion. The DePuy Synthes Navigation Ready Instrument, when used with UNAS, requires manual calibration with the Medtronic StealthStation navigation system.
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/K191943 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191943: SYMPHONY Navigation Ready Instruments, Universal Navigation Adaptor Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191943
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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