510(k) · Cleared
ClearedBlack Diamond Navigation Instruments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osseus Fusion Systems · OLO Orthopedic Stereotaxic Instrument
Cleared on Jan 17, 2020 as substantially equivalent to K140454 (Medtronic Sofamor Danek USA, Inc., 2014) and 2 other predicates after a 128-day review. Its family tree reaches back 12 generations to 1986. 1 of the 81 devices in its family, counting itself, has a Class I recall.
- Decided
- Jan 17, 2020
- Review
- 128 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 12 generations to K862807 (1986). 80 ancestors in all, the oldest K842956 (1984). No later device cites it as a predicate yet. 1 of the 81 devices in this family, counting this one, has a Class I recall.
- Root · 12 generations backK862807 Treace Drill SystemTreace Medical, Inc. · 1986
- 8 generations between
- 3 generations backK140454 Navigated CD Horizon Solera Screwdriver/TapsMedtronic Sofamor Danek USA, Inc. · 2014 · Recalled
- 2 generations backK143628 Navigated Vertex Select InstrumentsMedtronic Sofamor Danek USA, Inc. · 2015
- 1 generation backK172517 SeaSpine Navigation SystemSeaSpine Orthopedics Corporation · 2018 · Recalled
- This deviceK192495 Black Diamond Navigation InstrumentsOsseus Fusion Systems · 2020
Show all 12 generations
- Root · 12 generations backK862807 Treace Drill SystemTreace Medical, Inc. · 1986
- 11 generations backK964548 Apex Universal Drive SystemLinvatec Corp. · 1997
- 10 generations backK971059 Universal Drive SystemLinvatec Corp. · 1997
- 9 generations backK981637 Integrated Drive/Pump System for OtolaryngologyLinvatec Corp. · 1998
- 8 generations backK990524 E9000 SystemLinvatec Corp. · 1999
- 7 generations backK012456 Sodem High Speed System (Electric) (Ear, Nose, and Throat)Sodemsystems · 2001
- 6 generations backK081277 XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power…Medtronic Xomed, Inc. · 2008 · Recalled
- 5 generations backK111520 Ipc Powerease SystemMedtronic Xomed, Inc. · 2011 · Recalled
- 4 generations backK123270 Powerease SystemMedtronic Sofamor Danek USA, Inc. · 2013
- 3 generations backK140454 Navigated CD Horizon Solera Screwdriver/TapsMedtronic Sofamor Danek USA, Inc. · 2014 · Recalled
- 2 generations backK143628 Navigated Vertex Select InstrumentsMedtronic Sofamor Danek USA, Inc. · 2015
- 1 generation backK172517 SeaSpine Navigation SystemSeaSpine Orthopedics Corporation · 2018 · Recalled
- This deviceK192495 Black Diamond Navigation InstrumentsOsseus Fusion Systems · 2020
Class I recalls in this family
- K070106 VV Fluoro 3D2 generations back · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K862807 | Treace Drill System | Treace Medical, Inc. | 1986 | — |
| −11 | K964548 | Apex Universal Drive System | Linvatec Corp. | 1997 | — |
| −10 | K971059 | Universal Drive System | Linvatec Corp. | 1997 | — |
| −9 | K981637 | Integrated Drive/Pump System for Otolaryngology | Linvatec Corp. | 1998 | — |
| −8 | K990524 | E9000 System | Linvatec Corp. | 1999 | — |
| −7 | K012456 | Sodem High Speed System (Electric) (Ear, Nose, and Throat) | Sodemsystems | 2001 | — |
| −6 | K081277 | XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power CONS0LE (Ipc) | Medtronic Xomed, Inc. | 2008 | 1 |
| −5 | K111520 | Ipc Powerease System | Medtronic Xomed, Inc. | 2011 | 2 |
| −4 | K123270 | Powerease System | Medtronic Sofamor Danek USA, Inc. | 2013 | — |
| −3 | K140454 | Navigated CD Horizon Solera Screwdriver/Taps | Medtronic Sofamor Danek USA, Inc. | 2014 | 1 |
| −2 | K143628 | Navigated Vertex Select Instruments | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| −1 | K172517 | SeaSpine Navigation System | SeaSpine Orthopedics Corporation | 2018 | 1 |
| 0 (this device) | K192495 | Black Diamond Navigation Instruments | Osseus Fusion Systems | 2020 | — |
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 | 2 | 0 |
| 2000 | 6 | 0 |
| 2001 | 5 | 0 |
| 2002 | 4 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 5 | 0 |
| 2006 | 4 | 0 |
| 2007 | 1 | 1 |
| 2008 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 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? (3)
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 |
|---|---|---|---|
| * | K140454 | Navigated CD Horizon Solera Screwdriver/TapsSummary page 4…Panel Orthopedic Primary Predicate Navigated CD Horizon Solera Screwdrivers and Taps, Medtronic Sofamor Danek, USA Device Inc. (K140454) Universal Navigation Instruments for EXPEDIUM® and VIPER® MIS Spine Systems, Secondary Predicate… | 2014 |
| * | K140927 | Universal Navigation InstrumentsSummary page 4…Inc. (K140454) Universal Navigation Instruments for EXPEDIUM® and VIPER® MIS Spine Systems, Secondary Predicate DePuy Spine, Inc (K140927) Devices SeaSpine Navigation System, SeaSpine Orthopedics Corporation (K172517) Reference Predicate… | 2014 |
| * | K172517 | SeaSpine Navigation SystemSummary page 4…® MIS Spine Systems, Secondary Predicate DePuy Spine, Inc (K140927) Devices SeaSpine Navigation System, SeaSpine Orthopedics Corporation (K172517) Reference Predicate Black Diamond Pedicle Screw System, Osseus Fusion Systems (K131810) Devices… | 2018 |
| † | K131810 | Osseus Black Diamond Pedicle Screw System | 2013 |
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 · 2 generations back · ◆ in the 2007 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 34 years and passes through 7 companies; a new generation was cleared every 1.7 years on median.
- 14 of the 80 ancestors have a recall of any class; 1 has a Class I recall.
- 48 other devices also cite its predicate K140454.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 Black Diamond Navigation Instruments are intended to be used during the preparation and placement of Black Diamond pedicle screws during spinal surgery to aid the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Black Diamond Navigation Instruments are specifically designed for use with the Medtronic Stealth Station System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192495 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192495: Black Diamond 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/K192495
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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