510(k) · Cleared
ClearedVERTICALE® Navigation Instruments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Silony Medical GmbH · OLO Orthopedic Stereotaxic Instrument
Cleared on Jun 26, 2026 as substantially equivalent to K173338 (Medtronic Sofamor Danek USA, Inc., 2018) and 1 other predicate after a 200-day review. Its family tree reaches back 18 generations to 2004.
- Decided
- Jun 26, 2026
- Review
- 200 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 18 generations to K040583 (2004). 212 ancestors in all, the oldest K841189 (1984). No later device cites it as a predicate yet.
- Root · 18 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 14 generations between
- 3 generations backK143375 CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc. · 2015
- 2 generations backK212007 VERTICALE Navigation InstrumentsSilony Medical GmbH · 2021
- 1 generation backK223649 VERTICALE® Navigation InstrumentsSilony Medical GmbH · 2022
- This deviceK253921 VERTICALE® Navigation InstrumentsSilony Medical GmbH · 2026
Show all 18 generations
- Root · 18 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 17 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 16 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 15 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 14 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 13 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 12 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 11 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 10 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 9 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 8 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 7 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 6 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 5 generations backK122862 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 4 generations backK141605 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014
- 3 generations backK143375 CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc. · 2015
- 2 generations backK212007 VERTICALE Navigation InstrumentsSilony Medical GmbH · 2021
- 1 generation backK223649 VERTICALE® Navigation InstrumentsSilony Medical GmbH · 2022
- This deviceK253921 VERTICALE® Navigation InstrumentsSilony Medical GmbH · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −17 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −16 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −15 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −14 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −13 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −12 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −11 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −10 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −9 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −8 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −7 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −6 | K121680 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| −5 | K122862 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| −4 | K141605 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2014 | — |
| −3 | K143375 | CD HORIZON Spinal System, Medtronic Navigated Reusable Instruments | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| −2 | K212007 | VERTICALE Navigation Instruments | Silony Medical GmbH | 2021 | — |
| −1 | K223649 | VERTICALE® Navigation Instruments | Silony Medical GmbH | 2022 | — |
| 0 (this device) | K253921 | VERTICALE® Navigation Instruments | Silony Medical GmbH | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 2 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 8 | 0 |
| 1996 | 5 | 0 |
| 1997 | 5 | 0 |
| 1998 | 6 | 0 |
| 1999 | 6 | 0 |
| 2000 | 12 | 0 |
| 2001 | 15 | 0 |
| 2002 | 13 | 0 |
| 2003 | 12 | 0 |
| 2004 | 25 | 0 |
| 2005 | 17 | 0 |
| 2006 | 8 | 0 |
| 2007 | 5 | 0 |
| 2008 | 8 | 0 |
| 2009 | 2 | 0 |
| 2010 | 5 | 0 |
| 2011 | 8 | 0 |
| 2012 | 3 | 0 |
| 2013 | 6 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2018 | 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.
Planning a device in OLO? 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 |
|---|---|---|---|
| * | K173338 | Navigated INFINITY™ InstrumentsSummary page 6…Implant Compatibility Predicate Devices 510k # Trade or Proprietary or Model Name Manufacturer Product Code Predicate Type K173338 Navigated INFINITY™ Instruments Medtronic Sofamor Danek OLO Primary… | 2018 |
| * | K223649 | VERTICALE® Navigation InstrumentsSummary page 6…vigated INFINITY™ Instruments Medtronic Sofamor Danek OLO Primary USA, Inc. K223649 VERTICALE® Navigation Instruments Silony Medical GmbH OLO Additional The technical cha… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 4 companies; a new generation was cleared every 7 months on median.
- 30 of the 212 ancestors have a recall of any class.
- 6 other devices also cite its predicate K173338.
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 VERTICALE® Navigation Instruments are indicated for use during the preparation and insertion of VERTICALE® and VERTICALE® CERVICAL screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the third party stereotactic navigation systems (Medtronic StealthStation™, Brainlab or 7D) software which are indicated for any…
Read the full statement (104 words)
The VERTICALE® Navigation Instruments are indicated for use during the preparation and insertion of VERTICALE® and VERTICALE® CERVICAL screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the third party stereotactic navigation systems (Medtronic StealthStation™, Brainlab or 7D) software which are indicated for any medical condition in which the use of stereotactic surgery is suitable, and where reference to a rigid anatomical structure, such as vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized orientation points of the anatomy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253921 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253921: VERTICALE® 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/K253921
Report an extraction error
Are you the manufacturer?
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