510(k) · Cleared
ClearedFoundation Surgical Navigated Lateral Disc Prep Instruments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Foundation Surgical Group, Inc. · OLO Orthopedic Stereotaxic Instrument
Cleared on Apr 16, 2026 as substantially equivalent to K211441 (Medtronic Sofamor Danek USA, Inc., 2021) and 2 other predicates after a 104-day review. Its family tree reaches back 31 generations to 1984. 5 of the 905 devices in its family, counting itself, have a Class I recall.
- Decided
- Apr 16, 2026
- Review
- 104 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 31 generations to K841189 (1984). 904 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet. 5 of the 905 devices in this family, counting this one, have a Class I recall.
- Root · 31 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 27 generations between
- 3 generations backK212524 Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc. · 2021
- 2 generations backK214010 Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA · 2022
- 1 generation backK223494 CD Horizon Spinal SystemMedtronic · 2023
- This deviceK260011 Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc. · 2026
Show all 31 generations
- Root · 31 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 30 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 29 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 28 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 27 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 26 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 25 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 24 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 23 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 22 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 21 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 20 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 19 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 18 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 17 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 16 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 15 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 14 generations backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- 13 generations backK152304 Tritanium PL CageStryker · 2015 · Recalled
- 12 generations backK160955 Tritanium® PL CageStryker · 2016
- 11 generations backK162262 Tritanium® PL CageStryker · 2016
- 10 generations backK171496 Tritanium C Anterior Cervical CageStryker Spine · 2017
- 9 generations backK180364 HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC · 2018
- 8 generations backK183557 Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS…Titan Spine, Inc. · 2019 · Recalled
- 7 generations backK192018 Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS…Titan Spine, Inc. · 2019 · Recalled
- 6 generations backK191581 Endoskeleton TL Interbody Fusion Device, Endoskeleton TL…Titan Spine, Inc. · 2020
- 5 generations backK201267 Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek · 2020
- 4 generations backK210425 Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc. · 2021 · Recalled
- 3 generations backK212524 Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc. · 2021
- 2 generations backK214010 Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA · 2022
- 1 generation backK223494 CD Horizon Spinal SystemMedtronic · 2023
- This deviceK260011 Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc. · 2026
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −31 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −30 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −29 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −28 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −27 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −26 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −25 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −24 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −23 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −22 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −21 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −20 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −19 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −18 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −17 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −16 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −15 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −14 | K143616 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | 4 |
| −13 | K152304 | Tritanium PL Cage | Stryker | 2015 | 1 |
| −12 | K160955 | Tritanium® PL Cage | Stryker | 2016 | — |
| −11 | K162262 | Tritanium® PL Cage | Stryker | 2016 | — |
| −10 | K171496 | Tritanium C Anterior Cervical Cage | Stryker Spine | 2017 | — |
| −9 | K180364 | HD LifeSciences Cervical IBFD System | Hd Lifesciences, LLC | 2018 | — |
| −8 | K183557 | Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion… | Titan Spine, Inc. | 2019 | 3 |
| −7 | K192018 | Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS… | Titan Spine, Inc. | 2019 | 4 |
| −6 | K191581 | Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic… | Titan Spine, Inc. | 2020 | — |
| −5 | K201267 | Adaptix Interbody System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek | 2020 | — |
| −4 | K210425 | Catalyft PL Expandable Interbody System | Medtronic Sofamor Danek USA, Inc. | 2021 | 1 |
| −3 | K212524 | Anteralign Spinal System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek USA, Inc. | 2021 | — |
| −2 | K214010 | Anteralign Spinal System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek USA | 2022 | — |
| −1 | K223494 | CD Horizon Spinal System | Medtronic | 2023 | — |
| 0 (this device) | K260011 | Foundation Surgical Navigated Lateral Disc Prep Instruments | Foundation Surgical Group, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 2 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 2 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 7 | 0 |
| 1995 | 13 | 0 |
| 1996 | 13 | 0 |
| 1997 | 11 | 0 |
| 1998 | 17 | 0 |
| 1999 | 16 | 0 |
| 2000 | 22 | 0 |
| 2001 | 36 | 1 |
| 2002 | 27 | 0 |
| 2003 | 38 | 0 |
| 2004 | 60 | 0 |
| 2005 | 52 | 0 |
| 2006 | 34 | 0 |
| 2007 | 31 | 0 |
| 2008 | 66 | 1 |
| 2009 | 46 | 0 |
| 2010 | 39 | 0 |
| 2011 | 56 | 0 |
| 2012 | 38 | 0 |
| 2013 | 41 | 0 |
| 2014 | 47 | 0 |
| 2015 | 46 | 1 |
| 2016 | 27 | 1 |
| 2017 | 31 | 1 |
| 2018 | 11 | 0 |
| 2019 | 9 | 0 |
| 2020 | 11 | 0 |
| 2021 | 5 | 0 |
| 2022 | 2 | 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.
5 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 |
|---|---|---|---|
| * | K211441 | Navigated Anterolateral Disc Prep InstrumentsSummary page 6…nufacturer Product Predicate Code Type K211441 Navigated Anterolateral Disc Prep Instruments Medtronic Sofamore Danek USA, Inc. OLO Primary K131425 Navigated C… | 2021 |
| * | K131425 | Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale InserterSummary page 6…Code Type K211441 Navigated Anterolateral Disc Prep Instruments Medtronic Sofamore Danek USA, Inc. OLO Primary K131425 Navigated CLYDESDALE Trials Medtronic Navigation, Inc. OLO Additional K223494 Navigate… | 2013 |
| * | K223494 | CD Horizon Spinal SystemSummary page 6…nic Sofamore Danek USA, Inc. OLO Primary K131425 Navigated CLYDESDALE Trials Medtronic Navigation, Inc. OLO Additional K223494 Navigated Reusable Instruments for use with Medtronic Sofamor Danek, USA Inc OLO Additional StealthS… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (5 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 · 5 generations back · ◆ in the 2017 ancestors bar of FIG. 12 Class I recalls
- K153660StealthStation System with Cranial SoftwareMedtronic Navigation, Inc. · 2016 · 6 generations back · ◆ in the 2016 ancestors bar of FIG. 13 Class I recalls
- K150216Synergy CranialMedtronic Navigation, Inc. · 2015 · 7 generations back · ◆ in the 2015 ancestors bar of FIG. 13 Class I recalls
- K073202Ardis SpacerAbbott Spine, Inc. · 2008 · 7 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
- K003837Flexiview 8800 Digital Mobile Imaging SystemGe Oec Medical Systems · 2001 · 13 generations back · ◆ in the 2001 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 42 years and passes through 18 companies; a new generation was cleared every 9 months on median.
- 105 of the 904 ancestors have a recall of any class; 5 have a Class I recall.
- 2 other devices also cite its predicate K211441.
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?
Foundation Surgical Navigated Lateral Disc Prep Instruments are intended to be used during preparation of the intervertebral disc space during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Foundation Surgical Navigated Lateral Disc Prep Instruments are specifically designed for use with the Medtronic StealthStation™ S8 System, which is indicated for any medical condition…
Read the full statement (140 words)
Foundation Surgical Navigated Lateral Disc Prep Instruments are intended to be used during preparation of the intervertebral disc space during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures.
Foundation Surgical Navigated Lateral Disc Prep Instruments are specifically designed for use with the Medtronic StealthStation™ S8 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 of the anatomy. An instrument may incorporate a measuring function, which has uses as described on the label and the instruments.
The Navigated Trials are intended to be used to facilitate implant size selection of matching implants during spinal surgery.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K260011 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260011: Foundation Surgical Navigated Lateral 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/K260011
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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