510(k) · Cleared
Recalled · Class II · 2015Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy Taps
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Navigation, Inc. · OLO Orthopedic Stereotaxic Instrument
Cleared on Mar 22, 2013 as substantially equivalent to K050438 (Medtronic Surgical Navigation Technologies, 2005) and 1 other predicate after an 86-day review. Its family tree reaches back 8 generations to 1986. 1 of the 465 devices in its family, counting itself, has a Class I recall. 404 later devices descend from it. It has been recalled once.
- Decided
- Mar 22, 2013
- Review
- 86 days
- Class
- Class II
- Product code
- OLO
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 8 generations to K862807 (1986). 60 ancestors in all, the oldest K842956 (1984). 404 later devices descend from it, 15 citing it directly. 1 of the 465 devices in this family, counting this one, has a Class I recall.
- Root · 8 generations backK862807 Treace Drill SystemTreace Medical, Inc. · 1986
- 7 generations backK964548 Apex Universal Drive SystemLinvatec Corp. · 1997
- 6 generations backK971059 Universal Drive SystemLinvatec Corp. · 1997
- 5 generations backK981637 Integrated Drive/Pump System for OtolaryngologyLinvatec Corp. · 1998
- 4 generations backK990524 E9000 SystemLinvatec Corp. · 1999
- 3 generations backK012456 Sodem High Speed System (Electric) (Ear, Nose, and Throat)Sodemsystems · 2001
- 2 generations backK081277 XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power…Medtronic Xomed, Inc. · 2008 · Recalled
- 1 generation backK111520 Ipc Powerease SystemMedtronic Xomed, Inc. · 2011 · Recalled
- This deviceK124004 Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy…Medtronic Navigation, Inc. · 2013
- Descendant · cites it directly · 396 of its ownK140454 Navigated CD Horizon Solera Screwdriver/TapsMedtronic Sofamor Danek USA, Inc. · 2014 · Recalled
- Descendant · cites it directly · 246 of its ownK131425 Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale…Medtronic Navigation, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 242 of its ownK150231 Navigated Disc Prep Instruments and CAPSTONE TrialsMedtronic Sofamor Danek USA, Inc. · 2015
- Descendant · 2 generations on · 207 of its ownK143375 CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc. · 2015
- Descendant · 2 generations on · 206 of its ownK143628 Navigated Vertex Select InstrumentsMedtronic Sofamor Danek USA, Inc. · 2015
Showing 5 of 404 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 404 · See all- K140454Navigated CD Horizon Solera Screwdriver/TapsMedtronic Sofamor Danek USA, Inc. · 2014 · cites it directly396descendants
- K131425Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale InserterMedtronic Navigation, Inc. · 2013 · cites it directly246descendants
- K150231Navigated Disc Prep Instruments and CAPSTONE TrialsMedtronic Sofamor Danek USA, Inc. · 2015 · 2 generations on242descendants
- K143375CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc. · 2015 · 2 generations on207descendants
- K143628Navigated Vertex Select InstrumentsMedtronic Sofamor Danek USA, Inc. · 2015 · 2 generations on206descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K862807 | Treace Drill System | Treace Medical, Inc. | 1986 | — |
| −7 | K964548 | Apex Universal Drive System | Linvatec Corp. | 1997 | — |
| −6 | K971059 | Universal Drive System | Linvatec Corp. | 1997 | — |
| −5 | K981637 | Integrated Drive/Pump System for Otolaryngology | Linvatec Corp. | 1998 | — |
| −4 | K990524 | E9000 System | Linvatec Corp. | 1999 | — |
| −3 | K012456 | Sodem High Speed System (Electric) (Ear, Nose, and Throat) | Sodemsystems | 2001 | — |
| −2 | K081277 | XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power CONS0LE (Ipc) | Medtronic Xomed, Inc. | 2008 | 1 |
| −1 | K111520 | Ipc Powerease System | Medtronic Xomed, Inc. | 2011 | 2 |
| 0 (this device) | K124004 | Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy Taps | Medtronic Navigation, Inc. | 2013 | — |
| +1 | K140454 | Navigated CD Horizon Solera Screwdriver/Taps | Medtronic Sofamor Danek USA, Inc. | 2014 | 1 |
| +1 | K131425 | Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale Inserter | Medtronic Navigation, Inc. | 2013 | 10 |
| +2 | K150231 | Navigated Disc Prep Instruments and CAPSTONE Trials | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| +2 | K143375 | CD HORIZON Spinal System, Medtronic Navigated Reusable Instruments | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| +2 | K143628 | Navigated Vertex Select Instruments | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 5 | 0 |
| 2016 | 7 | 0 |
| 2017 | 11 | 0 |
| 2018 | 16 | 0 |
| 2019 | 24 | 0 |
| 2020 | 22 | 0 |
| 2021 | 39 | 1 |
| 2022 | 45 | 0 |
| 2023 | 61 | 0 |
| 2024 | 59 | 0 |
| 2025 | 60 | 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? (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 |
|---|---|---|---|
| * | K050438 | Stealthstation System UpdateSummary page 2…Y3 IX. Identification of Legally Marketing Devices (Predicate Devices) * StealthStation System Update (K050438) * IPC® POWEREASETM System (Ki111520) X. Cornparison of the Technological Characteristics: Item… | 2005 |
| * | K111520 | Ipc Powerease SystemSummary page 2…ical Working Ends Compatible with the PO WEREASEM System - K1 11520 ________________________________________________Steam sterilization The subject devices have the sa… | 2011 |
What descends from it? (404)
See all 40415 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140454 | Navigated CD Horizon Solera Screwdriver/Taps | 2014 | 396 |
| K131425 | Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale Inserter | 2013 | 246 |
| 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 |
| K172517 | SeaSpine Navigation System | 2018 | 60 |
| K201362 | CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone Cement | 2020 | 38 |
| K201251 | CarboClear Navigated Instruments | 2020 | 9 |
| K171267 | NavLock Trackers | 2017 | 4 |
| K181596 | Spine Wave Navigated Instruments | 2018 | 1 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 14, 2015 | Class II | Z-2823-2015 | Labeling design | Specific use conditions can increase the possibility of a screwdriver tip deforming or breaking during surgery. |
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 27 years and passes through 5 companies; a new generation was cleared every 2.2 years on median.
- 8 of the 60 ancestors have a recall of any class.
- Of its descendants, K140454 (Medtronic Sofamor Danek USA, Inc., 2014) has gone furthest, with 396 descendants of its own.
- 22 other devices also cite its predicate K050438.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 Navigated Taps and Screwdrivers are intended to be used during the preparation and placement of Medtronic screws during spinal surgery and are specifically designed for use with the Stealth Station® System, which is indicated for any medical condition in which the use of stereotactic surgery mnay be appropriate, and where reference to a rigid anatomical structure, such as the 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K124004 · printed Nov 6, 2026
Cite this page
510(k) Report. “K124004: Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy Taps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K124004
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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