510(k) · Cleared
Recalled · Class II · 2026ARVIS Surgical Navigation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Insight Medical Systems, Inc. · OLO Orthopedic Stereotaxic Instrument
Cleared on Jul 14, 2021 as substantially equivalent to K172462 (Orthalign, Inc., 2017) after a 271-day review. Its family tree reaches back 15 generations to 1999. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- Jul 14, 2021
- Review
- 271 days
- Class
- Class II
- Product code
- OLO
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 15 generations to K983831 (1999). 52 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 15 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 11 generations between
- 3 generations backK162962 OrthAlign Plus SystemOrthalign, Inc. · 2017
- 2 generations backK171780 OrthAlign Plus SystemOrthalign, Inc. · 2017
- 1 generation backK172462 OrthAlign Plus SystemOrthalign, Inc. · 2017
- This deviceK203115 ARVIS Surgical Navigation SystemInsight Medical Systems, Inc. · 2021
- Descendant · cites it directly · 1 of its ownK240062 ARVIS® ShoulderInsight Medical Systems, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK243980 ARVIS Surgical Navigation SystemKico Knee Innovation Company Pty Limited · 2025 · Recalled
- Descendant · 2 generations on · 0 of its ownK243950 ARVIS® ShoulderKico Knee Innovation Company Pty, Ltd. · 2025 · Recalled
Show all 15 generations
- Root · 15 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 14 generations backK014256 Kolibri Igs SystemsBrainlab AG · 2002
- 13 generations backK031770 CI TKR/UkrBrainlab AG · 2003
- 12 generations backK041899 Vectorvision Uni-KneeBrainlab AG · 2004
- 11 generations backK052966 CI Knee, CI MI TKRBrainlab AG · 2006
- 10 generations backK073615 Brainlab Knee Essential, Brainlab Knee Unlimited CI Knee, CI Knee…Brainlab AG · 2008
- 9 generations backK091411 Kneealign SystemOrthalign, Inc. · 2009
- 8 generations backK093998 Kneealign System with Reference SensorOrthalign, Inc. · 2010
- 7 generations backK103829 Kneealign SystemOrthalign, Inc. · 2011
- 6 generations backK130387 Orthoalign Plus SystemOrthalign, Inc. · 2013
- 5 generations backK140331 Orthalign Plus SystemOrthalign, Inc. · 2014
- 4 generations backK153237 OrthAlign Plus SystemOrthalign, Inc. · 2016
- 3 generations backK162962 OrthAlign Plus SystemOrthalign, Inc. · 2017
- 2 generations backK171780 OrthAlign Plus SystemOrthalign, Inc. · 2017
- 1 generation backK172462 OrthAlign Plus SystemOrthalign, Inc. · 2017
- This deviceK203115 ARVIS Surgical Navigation SystemInsight Medical Systems, Inc. · 2021
Most influential descendants
Showing 3 of 3 · See all- K240062ARVIS® ShoulderInsight Medical Systems, Inc. · 2024 · cites it directly1descendant
- K243980ARVIS Surgical Navigation SystemKico Knee Innovation Company Pty Limited · 2025 · cites it directly0descendants
- K243950ARVIS® ShoulderKico Knee Innovation Company Pty, Ltd. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K983831 | VECTORVISION2 | Brainlab AG | 1999 | — |
| −14 | K014256 | Kolibri Igs Systems | Brainlab AG | 2002 | — |
| −13 | K031770 | CI TKR/Ukr | Brainlab AG | 2003 | — |
| −12 | K041899 | Vectorvision Uni-Knee | Brainlab AG | 2004 | — |
| −11 | K052966 | CI Knee, CI MI TKR | Brainlab AG | 2006 | — |
| −10 | K073615 | Brainlab Knee Essential, Brainlab Knee Unlimited CI Knee, CI Knee Unlimited | Brainlab AG | 2008 | — |
| −9 | K091411 | Kneealign System | Orthalign, Inc. | 2009 | — |
| −8 | K093998 | Kneealign System with Reference Sensor | Orthalign, Inc. | 2010 | — |
| −7 | K103829 | Kneealign System | Orthalign, Inc. | 2011 | — |
| −6 | K130387 | Orthoalign Plus System | Orthalign, Inc. | 2013 | — |
| −5 | K140331 | Orthalign Plus System | Orthalign, Inc. | 2014 | — |
| −4 | K153237 | OrthAlign Plus System | Orthalign, Inc. | 2016 | — |
| −3 | K162962 | OrthAlign Plus System | Orthalign, Inc. | 2017 | — |
| −2 | K171780 | OrthAlign Plus System | Orthalign, Inc. | 2017 | — |
| −1 | K172462 | OrthAlign Plus System | Orthalign, Inc. | 2017 | — |
| 0 (this device) | K203115 | ARVIS Surgical Navigation System | Insight Medical Systems, Inc. | 2021 | — |
| +1 | K240062 | ARVIS® Shoulder | Insight Medical Systems, Inc. | 2024 | — |
| +1 | K243980 | ARVIS Surgical Navigation System | Kico Knee Innovation Company Pty Limited | 2025 | 1 |
| +2 | K243950 | ARVIS® Shoulder | Kico Knee Innovation Company Pty, Ltd. | 2025 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 3 | 0 |
| 2001 | 5 | 0 |
| 2002 | 5 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2011 | 2 | 0 |
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 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.
Planning a device in OLO? 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? (1)
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.
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 23, 2026 | Class II | Z-2293-2026 | Device Design | The Impactor V-Block Assembly and Trackers A, B, C and E may exhibit signs of early wear and/or corrosion on the exposed magnet face. |
| Apr 23, 2026 | Class II | Z-2292-2026 | Device Design | The V-Block Assembly and Trackers A, B, C and E may exhibit signs of early wear and/or corrosion on the exposed magnet face. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
- 7 of the 52 ancestors have a recall of any class.
- Of its descendants, K240062 (Insight Medical Systems, Inc., 2024) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K172462.
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?
The ARVIS® Surgical Navigation System is indicated for assisting the surgeon in the positioning and alignment of implants relative to reference alignment axes and landmarks in stereotactic orthopedic surgery. The system aids the surgeon in making intraoperative measurements such as changes in leg length in Hip Arthroplasty. The system is compatible with straight acetabular impactors and with specific offset impactors, identified in the instructions for use, for which an adapter has been validated.
Example orthopedic surgical procedures include but are not limited to:
» Total Knee Arthroplasty
» Unicompartmental Knee Arthroplasty: Tibial Transverse Resection
* Hip Arthroplasty
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/K203115 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203115: ARVIS Surgical Navigation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203115
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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