510(k) · Cleared
Recalled · Class II · 2023Navigated CD Horizon Solera Screwdriver/Taps
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek USA, Inc. · OLO Orthopedic Stereotaxic Instrument
Cleared on May 22, 2014 as substantially equivalent to K124004 (Medtronic Navigation, Inc., 2013) and 2 other predicates after an 87-day review. Its family tree reaches back 9 generations to 1986. 1 of the 459 devices in its family, counting itself, has a Class I recall. 396 later devices descend from it. It has been recalled once.
- Decided
- May 22, 2014
- Review
- 87 days
- Class
- Class II
- Product code
- OLO
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 9 generations to K862807 (1986). 62 ancestors in all, the oldest K842956 (1984). 396 later devices descend from it, 49 citing it directly. 1 of the 459 devices in this family, counting this one, has a Class I recall.
- Root · 9 generations backK862807 Treace Drill SystemTreace Medical, Inc. · 1986
- 5 generations between
- 3 generations backK081277 XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power…Medtronic Xomed, Inc. · 2008 · Recalled
- 2 generations backK111520 Ipc Powerease SystemMedtronic Xomed, Inc. · 2011 · Recalled
- 1 generation backK123270 Powerease SystemMedtronic Sofamor Danek USA, Inc. · 2013
- This deviceK140454 Navigated CD Horizon Solera Screwdriver/TapsMedtronic Sofamor Danek USA, Inc. · 2014
- Descendant · cites it directly · 242 of its ownK150231 Navigated Disc Prep Instruments and CAPSTONE TrialsMedtronic Sofamor Danek USA, Inc. · 2015
- Descendant · cites it directly · 207 of its ownK143375 CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc. · 2015
- Descendant · cites it directly · 206 of its ownK143628 Navigated Vertex Select InstrumentsMedtronic Sofamor Danek USA, Inc. · 2015
- Descendant · cites it directly · 112 of its ownK153203 Navigation InstrumentsGlobus Medical, Inc. · 2016
- Descendant · 2 generations on · 103 of its ownK163581 Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc. · 2017
Show all 9 generations
- Root · 9 generations backK862807 Treace Drill SystemTreace Medical, Inc. · 1986
- 8 generations backK964548 Apex Universal Drive SystemLinvatec Corp. · 1997
- 7 generations backK971059 Universal Drive SystemLinvatec Corp. · 1997
- 6 generations backK981637 Integrated Drive/Pump System for OtolaryngologyLinvatec Corp. · 1998
- 5 generations backK990524 E9000 SystemLinvatec Corp. · 1999
- 4 generations backK012456 Sodem High Speed System (Electric) (Ear, Nose, and Throat)Sodemsystems · 2001
- 3 generations backK081277 XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power…Medtronic Xomed, Inc. · 2008 · Recalled
- 2 generations backK111520 Ipc Powerease SystemMedtronic Xomed, Inc. · 2011 · Recalled
- 1 generation backK123270 Powerease SystemMedtronic Sofamor Danek USA, Inc. · 2013
- This deviceK140454 Navigated CD Horizon Solera Screwdriver/TapsMedtronic Sofamor Danek USA, Inc. · 2014
Showing 5 of 396 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub4 generations on · 2021
Most influential descendants
Showing 5 of 396 · See all- K150231Navigated Disc Prep Instruments and CAPSTONE TrialsMedtronic Sofamor Danek USA, Inc. · 2015 · cites it directly242descendants
- K143375CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc. · 2015 · cites it directly207descendants
- K143628Navigated Vertex Select InstrumentsMedtronic Sofamor Danek USA, Inc. · 2015 · cites it directly206descendants
- K153203Navigation InstrumentsGlobus Medical, Inc. · 2016 · cites it directly112descendants
- K163581Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc. · 2017 · 2 generations on103descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K862807 | Treace Drill System | Treace Medical, Inc. | 1986 | — |
| −8 | K964548 | Apex Universal Drive System | Linvatec Corp. | 1997 | — |
| −7 | K971059 | Universal Drive System | Linvatec Corp. | 1997 | — |
| −6 | K981637 | Integrated Drive/Pump System for Otolaryngology | Linvatec Corp. | 1998 | — |
| −5 | K990524 | E9000 System | Linvatec Corp. | 1999 | — |
| −4 | K012456 | Sodem High Speed System (Electric) (Ear, Nose, and Throat) | Sodemsystems | 2001 | — |
| −3 | K081277 | XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power CONS0LE (Ipc) | Medtronic Xomed, Inc. | 2008 | 1 |
| −2 | K111520 | Ipc Powerease System | Medtronic Xomed, Inc. | 2011 | 2 |
| −1 | K123270 | Powerease System | Medtronic Sofamor Danek USA, Inc. | 2013 | — |
| 0 (this device) | K140454 | Navigated CD Horizon Solera Screwdriver/Taps | Medtronic Sofamor Danek USA, Inc. | 2014 | — |
| +1 | K150231 | Navigated Disc Prep Instruments and CAPSTONE Trials | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| +1 | K143375 | CD HORIZON Spinal System, Medtronic Navigated Reusable Instruments | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| +1 | K143628 | Navigated Vertex Select Instruments | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| +1 | K153203 | Navigation Instruments | Globus Medical, Inc. | 2016 | — |
| +2 | K163581 | Navigated ELEVATE Inserter, Navigated Disc Prep Instruments | Medtronic Sofamor Danek USA, Inc. | 2017 | — |
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 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 5 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2008 | 2 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 5 | 0 |
| 2016 | 7 | 0 |
| 2017 | 10 | 0 |
| 2018 | 15 | 0 |
| 2019 | 24 | 0 |
| 2020 | 21 | 0 |
| 2021 | 38 | 1 |
| 2022 | 45 | 0 |
| 2023 | 61 | 0 |
| 2024 | 59 | 0 |
| 2025 | 58 | 0 |
| 2026 | 53 | 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 |
|---|---|---|---|
| * | K124004 | Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy TapsSummary page 2…IX. Identification of Legally Marketing Devices (Predicate Devices) * NAVIGATED CD HORIZON® SOLERA® SCREWDRIVERS, TAPS, ILIAC TAPS, LEGACYTM TAPS (K124004) * IPC® POWEREASETM System (KI 111520, K 123270) X. Comparison of the Technological Characteristics: The Navig… | 2013 |
| * | K111520 | Ipc Powerease SystemSummary page 2…Devices (Predicate Devices) * NAVIGATED CD HORIZON® SOLERA® SCREWDRIVERS, TAPS, ILIAC TAPS, LEGACYTM TAPS (K124004) * IPC® POWEREASETM System (KI 111520, K 123270) X. Comparison of the Technological Characteristics: The Navigated Taps and Screwdrivers are intended to be… | 2011 |
| * | K123270 | Powerease SystemSummary page 2…(Predicate Devices) * NAVIGATED CD HORIZON® SOLERA® SCREWDRIVERS, TAPS, ILIAC TAPS, LEGACYTM TAPS (K124004) * IPC® POWEREASETM System (KI 111520, K 123270) X. Comparison of the Technological Characteristics: The Navigated Taps and Screwdrivers are intended to be used duri… | 2013 |
What descends from it? (396)
See all 39649 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150231 | Navigated Disc Prep Instruments and CAPSTONE Trials | 2015 | 242 |
| K143375 | CD HORIZON Spinal System, Medtronic Navigated Reusable Instruments | 2015 | 207 |
| K143628 | Navigated Vertex Select Instruments | 2015 | 206 |
| K153203 | Navigation Instruments | 2016 | 112 |
| K153463 | CD HORIZON Spinal System, IPC POWEREASE System | 2015 | 87 |
| K170679 | CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC®… | 2017 | 86 |
| K153442 | CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with… | 2016 | 84 |
| K161210 | RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM)… | 2016 | 79 |
| K153603 | Alphatec Navigation Instruments | 2016 | 79 |
| K172517 | SeaSpine Navigation System | 2018 | 60 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 12, 2023 | Class II | Z-2363-2023 | Under Investigation by firm | Incorrect Laser Marking - Solera Awl Tip Tap |
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.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 28 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
- 9 of the 62 ancestors have a recall of any class.
- Of its descendants, K150231 (Medtronic Sofamor Danek USA, Inc., 2015) has gone furthest, with 242 descendants of its own.
- 14 other devices also cite its predicate K124004.
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?
Medtronic Navigated Reusable Instruments are intended to be used during the preparation and placement of Medtronic screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Medtronic Navigated Reusable Instruments are specifically designed for use with the StealthStation®E System, which is indicated for any medical condition in which the use of stereotactic surgery may…
Read the full statement (113 words)
Medtronic Navigated Reusable Instruments are intended to be used during the preparation and placement of Medtronic screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Medtronic Navigated Reusable Instruments are specifically designed for use with the StealthStation®E 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 skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. Medtronic Navigated Reusable Instruments are also compatible with the IPC®)POWEREASETM System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140454 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140454: Navigated CD Horizon Solera Screwdriver/Taps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140454
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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