510(k) · Cleared
ClearedInvictus Robotic Navigation Instruments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alphatec Spine · OLO Orthopedic Stereotaxic Instrument
Cleared on Jun 6, 2024 as substantially equivalent to K232044 (Alphatec Spine, Inc., 2023) and 2 other predicates after a 59-day review. Its family tree reaches back 32 generations to 1984. 2 of the 1,264 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it.
- Decided
- Jun 6, 2024
- Review
- 59 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 32 generations to K841189 (1984). 1,261 ancestors in all, the oldest K781443 (1978). 2 later devices descend from it, 1 citing it directly. 2 of the 1,264 devices in this family, counting this one, have a Class I recall.
- Root · 32 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 28 generations between
- 3 generations backK214006 Invictus® Spinal Fixation SystemAlphatec Spine, Inc. · 2022
- 2 generations backK221926 Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc. · 2022
- 1 generation backK232275 Invictus® Spinal Fixation SystemAlphatec Spine, Inc. · 2023
- This deviceK240951 Invictus Robotic Navigation InstrumentsAlphatec Spine · 2024
- Descendant · cites it directly · 1 of its ownK252597 Valence Robotic Navigation System; Valence Robotic Navigation…Alphatec Spine, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK261284 Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal…Alphatec Spine, Inc. · 2026
Show all 32 generations
- Root · 32 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 31 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 30 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 29 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 28 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 27 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 26 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 25 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 24 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 23 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 22 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 21 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 20 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 19 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 18 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 17 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 16 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 15 generations backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 14 generations backK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 13 generations backK170962 NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated · 2017
- 12 generations backK171633 NuVasive TLX Interbody SystemNu Vasive, Incorporated · 2017
- 11 generations backK180480 ATEC Universal Spacer SystemAlphatec Spine, Inc. · 2018
- 10 generations backK181453 ATEC ALIF Spacer SystemAlphatec Spine, Inc. · 2018
- 9 generations backK182746 ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc. · 2018
- 8 generations backK183705 IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc. · 2019
- 7 generations backK191311 ATEC Lateral Interbody SystemAlphatec Spine, Inc. · 2019
- 6 generations backK192938 Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2019
- 5 generations backK203056 Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2020
- 4 generations backK203742 IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc. · 2021
- 3 generations backK214006 Invictus® Spinal Fixation SystemAlphatec Spine, Inc. · 2022
- 2 generations backK221926 Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc. · 2022
- 1 generation backK232275 Invictus® Spinal Fixation SystemAlphatec Spine, Inc. · 2023
- This deviceK240951 Invictus Robotic Navigation InstrumentsAlphatec Spine · 2024
Class I recalls in this family
Most influential descendants
Showing 2 of 2 · See all- K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc. · 2026 · cites it directly1descendant
- K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −32 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −31 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −30 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −29 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −28 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −27 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −26 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −25 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −24 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −23 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −22 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −21 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −20 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −19 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −18 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −17 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −16 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −15 | K153782 | NuVasive® Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −14 | K161230 | NuVasive Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −13 | K170962 | NuVasive® CoRoent® Thoracolumbar System | Nu Vasive, Incorporated | 2017 | — |
| −12 | K171633 | NuVasive TLX Interbody System | Nu Vasive, Incorporated | 2017 | — |
| −11 | K180480 | ATEC Universal Spacer System | Alphatec Spine, Inc. | 2018 | — |
| −10 | K181453 | ATEC ALIF Spacer System | Alphatec Spine, Inc. | 2018 | — |
| −9 | K182746 | ATEC ALIF and LLIF Spacer System | Alphatec Spine, Inc. | 2018 | — |
| −8 | K183705 | IdentiTi Porous Ti Interbody System | Alphatec Spine, Inc. | 2019 | — |
| −7 | K191311 | ATEC Lateral Interbody System | Alphatec Spine, Inc. | 2019 | — |
| −6 | K192938 | Invictus™ Spinal Fixation System | Alphatec Spine, Inc. | 2019 | — |
| −5 | K203056 | Invictus™ Spinal Fixation System | Alphatec Spine, Inc. | 2020 | — |
| −4 | K203742 | IdentiTi ALIF Standalone Interbody System | Alphatec Spine, Inc. | 2021 | — |
| −3 | K214006 | Invictus® Spinal Fixation System | Alphatec Spine, Inc. | 2022 | — |
| −2 | K221926 | Invictus® Bone Cement, Invictus Spinal Fixation System | Alphatec Spine, Inc. | 2022 | — |
| −1 | K232275 | Invictus® Spinal Fixation System | Alphatec Spine, Inc. | 2023 | — |
| 0 (this device) | K240951 | Invictus Robotic Navigation Instruments | Alphatec Spine | 2024 | — |
| +1 | K252597 | Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For… | Alphatec Spine, Inc. | 2026 | — |
| +2 | K261284 | Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation… | Alphatec Spine, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1979 | 2 | 0 |
| 1980 | 1 | 0 |
| 1981 | 2 | 0 |
| 1984 | 2 | 0 |
| 1985 | 2 | 0 |
| 1986 | 2 | 0 |
| 1987 | 3 | 0 |
| 1988 | 2 | 0 |
| 1989 | 5 | 0 |
| 1990 | 4 | 0 |
| 1991 | 2 | 0 |
| 1992 | 11 | 0 |
| 1993 | 7 | 0 |
| 1994 | 10 | 0 |
| 1995 | 23 | 0 |
| 1996 | 22 | 0 |
| 1997 | 18 | 0 |
| 1998 | 31 | 0 |
| 1999 | 31 | 0 |
| 2000 | 48 | 0 |
| 2001 | 61 | 0 |
| 2002 | 50 | 0 |
| 2003 | 54 | 0 |
| 2004 | 86 | 0 |
| 2005 | 81 | 0 |
| 2006 | 62 | 0 |
| 2007 | 52 | 0 |
| 2008 | 103 | 1 |
| 2009 | 73 | 0 |
| 2010 | 64 | 1 |
| 2011 | 69 | 0 |
| 2012 | 40 | 0 |
| 2013 | 42 | 0 |
| 2014 | 48 | 0 |
| 2015 | 37 | 0 |
| 2016 | 25 | 0 |
| 2017 | 22 | 0 |
| 2018 | 13 | 0 |
| 2019 | 6 | 0 |
| 2020 | 5 | 0 |
| 2021 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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.
2 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 |
|---|---|---|---|
| * | K232044 | Invictus Robotic Navigation InstrumentsSummary page 4…LLY MARKETED PREDICATE DEVICES Primary Predicate Device: 510(k) Product Name Clearance Date K232044 Invictus Robotic Navigation Instruments October 6, 2023 Additional Predicate Devices: 5… | 2023 |
| * | K232275 | Invictus® Spinal Fixation SystemSummary page 4…October 6, 2023 Additional Predicate Devices: 510(k) Product Name Clearance Date K232275 Invictus Spinal Fixation System September 27, 2023 K171651 EXCELSIUS G… | 2023 |
| * | K171651 | Excelsius GPSSummary page 4…Product Name Clearance Date K232275 Invictus Spinal Fixation System September 27, 2023 K171651 EXCELSIUS GPS® August 16, 2017 Reference Devices: 510(k)… | 2017 |
| † | K161363 | Arsenal Spinal Fixation System | 2016 |
| † | K203742 | IdentiTi ALIF Standalone Interbody System | 2021 |
| † | K083416 | Revolve Stabilization System | 2009 |
| † | K111449 | Revolve Additional Implants | 2011 |
| † | K124058 | Creo Stabilization System | 2013 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252597 | Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with… | 2026 | 1 |
Has anything in its family been recalled? (2 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.
What does this lineage say?
- The line of descent spans 40 years and passes through 14 companies; a new generation was cleared every 9 months on median.
- 158 of the 1,261 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K252597 (Alphatec Spine, Inc., 2026) has gone furthest, with 1 descendant of its own.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 Invictus Robotic Navigation Instruments are indicated for use during the placement of Invictus Spinal Fixation System screws in either open or minimally invasive procedures. The Invictus Robotic Navigation Instruments are specifically designed for use with Globus Medical’s Excelsius GPS® Robotic Navigation Platform, which is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of an…
Read the full statement (105 words)
The Invictus Robotic Navigation Instruments are indicated for use during the placement of Invictus Spinal Fixation System screws in either open or minimally invasive procedures. The Invictus Robotic Navigation Instruments are specifically designed for use with Globus Medical’s Excelsius GPS® Robotic Navigation Platform, which is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous procedures, provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240951 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240951: Invictus Robotic Navigation Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240951
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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