510(k) · Cleared
ClearedSYMPHONY Navigation Ready 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 Mar 27, 2026 as substantially equivalent to K201661 (Medos International SARL, 2020) after a 60-day review. Its family tree reaches back 8 generations to 1999. 1 of the 18 devices in its family, counting itself, has a Class I recall.
- Decided
- Mar 27, 2026
- Review
- 60 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K983831 (1999). 17 ancestors in all, the oldest K981508 (1998). No later device cites it as a predicate yet. 1 of the 18 devices in this family, counting this one, has a Class I recall.
- Root · 8 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 7 generations backK014256 Kolibri Igs SystemsBrainlab AG · 2002
- 6 generations backK042721 Kolibri SpineBrainlab AG · 2005
- 5 generations backK053159 Vectorvision SpineBrainlab AG · 2006 · Recalled
- 4 generations backK070106 VV Fluoro 3DBrainlab AG · 2007 · Recalled (Class I)
- 3 generations backK083310 Spine & Trauma IctBrainlab AG · 2009
- 2 generations backK183605 Spine & Trauma NavigationBrainlab AG · 2019 · Recalled
- 1 generation backK201661 Symphony Navigation Ready Instruments and Universal Navigation…Medos International SARL · 2020
- This deviceK260240 SYMPHONY Navigation Ready InstrumentsMedos International SARL · 2026
Class I recalls in this family
- K070106 VV Fluoro 3D3 generations back · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K983831 | VECTORVISION2 | Brainlab AG | 1999 | — |
| −7 | K014256 | Kolibri Igs Systems | Brainlab AG | 2002 | — |
| −6 | K042721 | Kolibri Spine | Brainlab AG | 2005 | — |
| −5 | K053159 | Vectorvision Spine | Brainlab AG | 2006 | 1 |
| −4 | K070106 | VV Fluoro 3D | Brainlab AG | 2007 | Class I |
| −3 | K083310 | Spine & Trauma Ict | Brainlab AG | 2009 | — |
| −2 | K183605 | Spine & Trauma Navigation | Brainlab AG | 2019 | 3 |
| −1 | K201661 | Symphony Navigation Ready Instruments and Universal Navigation Adaptor Set | Medos International SARL | 2020 | — |
| 0 (this device) | K260240 | SYMPHONY Navigation Ready Instruments | Medos International SARL | 2026 | — |
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 |
| 2019 | 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? (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 |
|---|---|---|---|
| * | K201661 | Symphony Navigation Ready Instruments and Universal Navigation Adaptor SetSummary page 5…Orthopedic D. Predicate Device Names Primary Predicate Device: Symphony Navigation Ready Instruments and Universal Navigation Adaptor Set (K201661) – OLO Reference Devices: TELIGEN System Navigation Ready Instruments (K233254) – OLO Spine Navigation and Robot… | 2020 |
| † | K233254 | TELIGEN System Navigation Ready Instruments | 2024 |
| † | K233228 | Spine Navigation and Robotic-Assistance Device | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
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 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 27 years and passes through 2 companies; a new generation was cleared every 2.8 years on median.
- 5 of the 17 ancestors have a recall of any class; 1 has a Class I recall.
- 2 other devices also cite its predicate K201661.
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?
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…
Read the full statement (183 words)
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 and associated tracking arrays.
These procedures include but are not limited to spinal fusion. The SYMPHONY Navigation Ready Instruments can be:
• pre-calibrated with the VELYS™ SPINE Navigation using the VELYS™ SPINE Instrument Arrays,
• pre-calibrated and/or manually calibrated with the Brainlab Navigation System using the UNAS Navigation Arrays,
• manually calibrated with other navigation systems, using tracking arrays supplied by the navigation system manufacturer.
The SYMPHONY Navigation Ready Instruments are intended to support indicated cervical and thoracic polyaxial screw placement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260240 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260240: SYMPHONY Navigation Ready Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260240
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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