510(k) · Cleared
ClearedCatalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal System with Titan nanoLOCK™ Surface Technology Navigated Instruments, and CD Horizon™ Solera™ Voyager™ Spinal System Navigated, Guided, and Powered Drivers
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 Feb 9, 2022 as substantially equivalent to K211596 (Medtronic, 2021) and 2 other predicates after a 49-day review. Its family tree reaches back 29 generations to 1984. 1 of the 601 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Feb 9, 2022
- Review
- 49 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 29 generations to K841189 (1984). 599 ancestors in all, the oldest K792352 (1979). 1 later device descends from it, 1 citing it directly. 1 of the 601 devices in this family, counting this one, has a Class I recall.
- Root · 29 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 25 generations between
- 3 generations backK201267 Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek · 2020
- 2 generations backK210425 Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc. · 2021 · Recalled
- 1 generation backK212524 Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc. · 2021
- This deviceK214011 Catalyft™ PL Expandable Interbody System Navigated Instruments…Medtronic Sofamor Danek USA, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK222383 Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology…Medtronic Sofamor Danek USA, Inc. · 2022
Show all 29 generations
- Root · 29 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 28 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 27 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 26 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 25 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 24 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 23 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 22 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 21 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 20 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 19 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 18 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 17 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 16 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 15 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 14 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 13 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 12 generations backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- 11 generations backK152304 Tritanium PL CageStryker · 2015 · Recalled
- 10 generations backK160955 Tritanium® PL CageStryker · 2016
- 9 generations backK162262 Tritanium® PL CageStryker · 2016
- 8 generations backK171496 Tritanium C Anterior Cervical CageStryker Spine · 2017
- 7 generations backK180364 HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC · 2018
- 6 generations backK183557 Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS…Titan Spine, Inc. · 2019 · Recalled
- 5 generations backK192018 Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS…Titan Spine, Inc. · 2019 · Recalled
- 4 generations backK191581 Endoskeleton TL Interbody Fusion Device, Endoskeleton TL…Titan Spine, Inc. · 2020
- 3 generations backK201267 Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek · 2020
- 2 generations backK210425 Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc. · 2021 · Recalled
- 1 generation backK212524 Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc. · 2021
- This deviceK214011 Catalyft™ PL Expandable Interbody System Navigated Instruments…Medtronic Sofamor Danek USA, Inc. · 2022
Class I recalls in this family
- K073202 Ardis Spacer6 generations back · 2008
Most influential descendants
Showing 1 of 1 · See all- K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −29 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −28 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −27 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −26 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −25 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −24 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −23 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −22 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −21 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −20 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −19 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −18 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −17 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −16 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −15 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −14 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −13 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −12 | K143616 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | 4 |
| −11 | K152304 | Tritanium PL Cage | Stryker | 2015 | 1 |
| −10 | K160955 | Tritanium® PL Cage | Stryker | 2016 | — |
| −9 | K162262 | Tritanium® PL Cage | Stryker | 2016 | — |
| −8 | K171496 | Tritanium C Anterior Cervical Cage | Stryker Spine | 2017 | — |
| −7 | K180364 | HD LifeSciences Cervical IBFD System | Hd Lifesciences, LLC | 2018 | — |
| −6 | K183557 | Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion… | Titan Spine, Inc. | 2019 | 3 |
| −5 | K192018 | Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS… | Titan Spine, Inc. | 2019 | 4 |
| −4 | K191581 | Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic… | Titan Spine, Inc. | 2020 | — |
| −3 | K201267 | Adaptix Interbody System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek | 2020 | — |
| −2 | K210425 | Catalyft PL Expandable Interbody System | Medtronic Sofamor Danek USA, Inc. | 2021 | 1 |
| −1 | K212524 | Anteralign Spinal System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek USA, Inc. | 2021 | — |
| 0 (this device) | K214011 | Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL… | Medtronic Sofamor Danek USA, Inc. | 2022 | — |
| +1 | K222383 | Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX… | Medtronic Sofamor Danek USA, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 7 | 0 |
| 1996 | 4 | 0 |
| 1997 | 5 | 0 |
| 1998 | 6 | 0 |
| 1999 | 6 | 0 |
| 2000 | 9 | 0 |
| 2001 | 14 | 0 |
| 2002 | 16 | 0 |
| 2003 | 22 | 0 |
| 2004 | 41 | 0 |
| 2005 | 33 | 0 |
| 2006 | 17 | 0 |
| 2007 | 19 | 0 |
| 2008 | 54 | 1 |
| 2009 | 39 | 0 |
| 2010 | 28 | 0 |
| 2011 | 45 | 0 |
| 2012 | 30 | 0 |
| 2013 | 34 | 0 |
| 2014 | 35 | 0 |
| 2015 | 32 | 0 |
| 2016 | 20 | 0 |
| 2017 | 19 | 0 |
| 2018 | 6 | 0 |
| 2019 | 3 | 0 |
| 2020 | 5 | 0 |
| 2021 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 |
|---|---|---|---|
| * | K211596 | CD Horizon Spinal SystemSummary page 4…CD Horizon™ Spinal System ModuLeX Instruments for use with MAZOR X Stealth Edition (K211596, S.E. 06/23/2021)… | 2021 |
| * | K210425 | Catalyft PL Expandable Interbody SystemSummary page 5…t Code: OLO Additional Predicate Catalyft™ PL Expandable Interbody System Navigated Instruments (K210425, S.E. 05/24/2021) Classification:… | 2021 |
| * | K212524 | Anteralign Spinal System with Titan nanoLOCK Surface TechnologySummary page 5…pinal System with Titan nanoLOCK™ Surface Technology Navigated Instruments (K212524, S.E. 12/08/2021) Classification:… | 2021 |
| † | K050438 | Stealthstation System Update | 2005 |
| † | K201189 | Stealthstation S8 Spine Software v1.3.0 | 2020 |
| † | K182077 | Mazor X System (Mazor X Stealth Edition) | 2018 |
| † | K203005 | Mazor X | 2020 |
| † | K111520 | Ipc Powerease System | 2011 |
| † | K123270 | Powerease System | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222383 | Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)… | 2022 | 0 |
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.
- K073202Ardis SpacerAbbott Spine, Inc. · 2008 · 6 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 38 years and passes through 15 companies; a new generation was cleared every 8 months on median.
- 70 of the 599 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K222383 (Medtronic Sofamor Danek USA, Inc., 2022) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K211596.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 are intended to be used during preparation and placement of Medtronic implants during spinal surgery to assist 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 medical conditions in which the use of stereotactic surgery may be appropriate, and where…
Read the full statement (196 words)
Medtronic Surgical Instruments are intended to be used during preparation and placement of Medtronic implants during spinal surgery to assist 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 medical conditions 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 Guide. 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 cannulas may or may not be used with Midas Rex™ attachments and tools.
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/K214011 · printed Nov 6, 2026
Cite this page
510(k) Report. “K214011: Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal System with Titan nanoLOCK™ Surface Technology Navigated Instruments, and CD Horizon™ Solera™ Voyager™ Spinal System Navigated, Guided, and Powered Drivers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K214011
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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