510(k) · Cleared
ClearedNavigated Anterolateral Disc Prep Instruments
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 Jun 9, 2021 as substantially equivalent to K150231 (Medtronic Sofamor Danek USA, Inc., 2015) and 2 other predicates after a 30-day review. Its family tree reaches back 19 generations to 2001. 4 of the 296 devices in its family, counting itself, have a Class I recall. 9 later devices descend from it.
- Decided
- Jun 9, 2021
- Review
- 30 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 19 generations to K003155 (2001). 286 ancestors in all, the oldest K792352 (1979). 9 later devices descend from it, 3 citing it directly. 4 of the 296 devices in this family, counting this one, have a Class I recall.
- Root · 19 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 15 generations between
- 3 generations backK163581 Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc. · 2017
- 2 generations backK191039 Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc. · 2019
- 1 generation backK192336 Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc. · 2019
- This deviceK211441 Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc. · 2021
- Descendant · cites it directly · 4 of its ownK240625 CORUS Navigation Access SystemProvidence Medical Technology, Inc. · 2024
- Descendant · cites it directly · 2 of its ownK232345 ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc. · 2023
- Descendant · 2 generations on · 1 of its ownK260329 Ion-C Navigation InstrumentsSurGenTec, LLC · 2026
- Descendant · 2 generations on · 1 of its ownK252597 Valence Robotic Navigation System; Valence Robotic Navigation…Alphatec Spine, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK262121 Ion-L Navigated InstrumentsSurGenTec, LLC · 2026
Show all 19 generations
- Root · 19 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 18 generations backK012254 VBROsteotech, Inc. · 2001
- 17 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 16 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 15 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 14 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 13 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 12 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 11 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 10 generations backK062133 Modification to Verte-Stack Spinal SystemMedtronic Spinal and Biologics Div · 2006
- 9 generations backK070173 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2007
- 8 generations backK073285 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc. · 2008
- 7 generations backK100214 Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek · 2010
- 6 generations backK111264 Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA · 2011
- 5 generations backK122037 Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion…Medtronic Sofamor Danek, Inc. · 2013
- 4 generations backK142559 ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2015
- 3 generations backK163581 Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc. · 2017
- 2 generations backK191039 Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc. · 2019
- 1 generation backK192336 Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc. · 2019
- This deviceK211441 Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc. · 2021
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 9 · See all- K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc. · 2024 · cites it directly4descendants
- K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc. · 2023 · cites it directly2descendants
- K260329Ion-C Navigation InstrumentsSurGenTec, LLC · 2026 · 2 generations on1descendant
- K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc. · 2026 · 2 generations on1descendant
- K262121Ion-L Navigated InstrumentsSurGenTec, LLC · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −18 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −17 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −16 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −15 | K030601 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −14 | K040536 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −13 | K041556 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −12 | K043561 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −11 | K060719 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −10 | K062133 | Modification to Verte-Stack Spinal System | Medtronic Spinal and Biologics Div | 2006 | — |
| −9 | K070173 | Verte-Stack Spinal System | Medtronic Sofamor Danek, Inc. | 2007 | — |
| −8 | K073285 | Peek Prevail Cervical Interbody Device | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −7 | K100214 | Cornerstone PSR Cervical Interbody Fusion Device | Medtronic Sofamor Danek | 2010 | — |
| −6 | K111264 | Cornerstone (R) PSR Cervical Fusion System | Medtronic Sofamor Danek USA | 2011 | — |
| −5 | K122037 | Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System… | Medtronic Sofamor Danek, Inc. | 2013 | — |
| −4 | K142559 | ELEVATE Spinal System | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| −3 | K163581 | Navigated ELEVATE Inserter, Navigated Disc Prep Instruments | Medtronic Sofamor Danek USA, Inc. | 2017 | — |
| −2 | K191039 | Navigated T2 STRATOSPHERE Inserters and Navigated Templates | Medtronic Sofamor Danek USA, Inc. | 2019 | — |
| −1 | K192336 | Navigated Anterolateral Disc Prep Instruments | Medtronic Sofamor Danek USA, Inc. | 2019 | — |
| 0 (this device) | K211441 | Navigated Anterolateral Disc Prep Instruments | Medtronic Sofamor Danek USA, Inc. | 2021 | — |
| +1 | K240625 | CORUS Navigation Access System | Providence Medical Technology, Inc. | 2024 | — |
| +1 | K232345 | ATEC Posterior Navigated Disc Prep Instruments | Alphatec Spine, Inc. | 2023 | — |
| +2 | K260329 | Ion-C Navigation Instruments | SurGenTec, LLC | 2026 | — |
| +2 | K252597 | Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For… | Alphatec Spine, Inc. | 2026 | — |
| +3 | K262121 | Ion-L Navigated Instruments | SurGenTec, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1984 | 2 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 2 | 0 |
| 1992 | 2 | 0 |
| 1994 | 6 | 0 |
| 1995 | 10 | 0 |
| 1996 | 6 | 0 |
| 1997 | 8 | 0 |
| 1998 | 8 | 0 |
| 1999 | 9 | 0 |
| 2000 | 9 | 0 |
| 2001 | 19 | 1 |
| 2002 | 14 | 0 |
| 2003 | 20 | 0 |
| 2004 | 24 | 0 |
| 2005 | 14 | 0 |
| 2006 | 7 | 0 |
| 2007 | 13 | 0 |
| 2008 | 24 | 0 |
| 2009 | 11 | 0 |
| 2010 | 8 | 0 |
| 2011 | 13 | 0 |
| 2012 | 6 | 0 |
| 2013 | 4 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 1 |
| 2016 | 1 | 1 |
| 2017 | 4 | 1 |
| 2018 | 2 | 0 |
| 2020 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 5 | 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.
4 devices in this family have 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 |
|---|---|---|---|
| * | K150231 | Navigated Disc Prep Instruments and CAPSTONE TrialsSummary page 5…Class II Product Code: OLO III. Predicates: Primary Predicate Navigated Disc Prep Instruments (K150231, S.E. 06/16/2015; K203005, S.E. 10/27/2020)… | 2015 |
| * | K203005 | Mazor XSummary page 5…edicates: Primary Predicate Navigated Disc Prep Instruments (K150231, S.E. 06/16/2015; K203005, S.E. 10/27/2020) Classification: Class II… | 2020 |
| * | K192336 | Navigated Anterolateral Disc Prep InstrumentsSummary page 5…FDA Product Code: OLO Additional Predicate Navigated Anterolateral Disc Prep Instruments (K192336, S.E. 11/22/2019) Page 1 of 3.… | 2019 |
What descends from it? (9)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (4 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.
- K162309StealthStation S8 System Platforms and StealthStation Cranial SoftwareMedtronic Navigation, Inc. · 2017 · 4 generations back · ◆ in the 2017 ancestors bar of FIG. 12 Class I recalls
- K153660StealthStation System with Cranial SoftwareMedtronic Navigation, Inc. · 2016 · 5 generations back · ◆ in the 2016 ancestors bar of FIG. 13 Class I recalls
- K150216Synergy CranialMedtronic Navigation, Inc. · 2015 · 6 generations back · ◆ in the 2015 ancestors bar of FIG. 13 Class I recalls
- K003837Flexiview 8800 Digital Mobile Imaging SystemGe Oec Medical Systems · 2001 · 12 generations back · ◆ in the 2001 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 20 years and passes through 6 companies; a new generation was cleared every 1.1 years on median.
- 41 of the 286 ancestors have a recall of any class; 4 have a Class I recall.
- Of its descendants, K240625 (Providence Medical Technology, Inc., 2024) has gone furthest, with 4 descendants of its own.
- 10 other devices also cite its predicate K150231.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 Surgical Instruments for use with MAZOR X Stealth™ Edition Medtronic Surgical Instruments are intended to be used during the preparation and placement of Medtronic implants during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, or minimally invasive, procedures. Medtronic Surgical Instruments are specifically designed for use with the MAZOR X Stealth™ Edition, which is indicated for any medical…
Read the full statement (337 words)
Medtronic Surgical Instruments for use with MAZOR X Stealth™ Edition
Medtronic Surgical Instruments are intended to be used during the preparation and placement of Medtronic implants during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, or minimally invasive, procedures. Medtronic Surgical Instruments are specifically designed for use with the MAZOR X Stealth™ Edition, 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 Surgical Instruments can be navigated or non-navigated manual instruments that may or may not be guided through the MAZOR X Stealth™ Edition Arm Gide. Medtronic surgical drills shall only be used through the MAZOR X Stealth™ Edition arm guides, Medtronic cannulas, and Medtronic drill guides. Some of the Medtronic Surgical Instruments are also compatible with the IPC™ POWEREASE™ System or AO style quick connect drilling motors. An instrument may incorporate a measuring function which has uses as described on the label and the instrument.
Medtronic Navigated Manual Reusable Instruments for Use with the StealthStation™ System
Medtronic Navigated Surgical Instruments are intended to be used during preparation and placement of Medtronic implants during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Medtronic Navigated Reusable Instruments can be compatible with various Medtronic spinal implant systems. Navigated surgical instruments are specifically designed for use with the StealthStation™ 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. An instrument may incorporate a measuring function, which has uses as described on the label and the instruments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211441 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211441: Navigated Anterolateral Disc Prep Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211441
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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