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
Kico Knee Innovation Company Pty Limited · SBF Orthopedic Augmented Reality
Cleared on Mar 21, 2025 as substantially equivalent to K203115 (Insight Medical Systems, Inc., 2021) after an 88-day review. Its family tree reaches back 16 generations to 1999. It has been recalled once.
- Decided
- Mar 21, 2025
- Review
- 88 days
- Class
- Class II
- Product code
- SBF
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 16 generations to K983831 (1999). 53 ancestors in all. No later device cites it as a predicate yet.
- Root · 16 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 12 generations between
- 3 generations backK171780 OrthAlign Plus SystemOrthalign, Inc. · 2017
- 2 generations backK172462 OrthAlign Plus SystemOrthalign, Inc. · 2017
- 1 generation backK203115 ARVIS Surgical Navigation SystemInsight Medical Systems, Inc. · 2021 · Recalled
- This deviceK243980 ARVIS Surgical Navigation SystemKico Knee Innovation Company Pty Limited · 2025
Show all 16 generations
- Root · 16 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 15 generations backK014256 Kolibri Igs SystemsBrainlab AG · 2002
- 14 generations backK031770 CI TKR/UkrBrainlab AG · 2003
- 13 generations backK041899 Vectorvision Uni-KneeBrainlab AG · 2004
- 12 generations backK052966 CI Knee, CI MI TKRBrainlab AG · 2006
- 11 generations backK073615 Brainlab Knee Essential, Brainlab Knee Unlimited CI Knee, CI Knee…Brainlab AG · 2008
- 10 generations backK091411 Kneealign SystemOrthalign, Inc. · 2009
- 9 generations backK093998 Kneealign System with Reference SensorOrthalign, Inc. · 2010
- 8 generations backK103829 Kneealign SystemOrthalign, Inc. · 2011
- 7 generations backK130387 Orthoalign Plus SystemOrthalign, Inc. · 2013
- 6 generations backK140331 Orthalign Plus SystemOrthalign, Inc. · 2014
- 5 generations backK153237 OrthAlign Plus SystemOrthalign, Inc. · 2016
- 4 generations backK162962 OrthAlign Plus SystemOrthalign, Inc. · 2017
- 3 generations backK171780 OrthAlign Plus SystemOrthalign, Inc. · 2017
- 2 generations backK172462 OrthAlign Plus SystemOrthalign, Inc. · 2017
- 1 generation backK203115 ARVIS Surgical Navigation SystemInsight Medical Systems, Inc. · 2021 · Recalled
- This deviceK243980 ARVIS Surgical Navigation SystemKico Knee Innovation Company Pty Limited · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K983831 | VECTORVISION2 | Brainlab AG | 1999 | — |
| −15 | K014256 | Kolibri Igs Systems | Brainlab AG | 2002 | — |
| −14 | K031770 | CI TKR/Ukr | Brainlab AG | 2003 | — |
| −13 | K041899 | Vectorvision Uni-Knee | Brainlab AG | 2004 | — |
| −12 | K052966 | CI Knee, CI MI TKR | Brainlab AG | 2006 | — |
| −11 | K073615 | Brainlab Knee Essential, Brainlab Knee Unlimited CI Knee, CI Knee Unlimited | Brainlab AG | 2008 | — |
| −10 | K091411 | Kneealign System | Orthalign, Inc. | 2009 | — |
| −9 | K093998 | Kneealign System with Reference Sensor | Orthalign, Inc. | 2010 | — |
| −8 | K103829 | Kneealign System | Orthalign, Inc. | 2011 | — |
| −7 | K130387 | Orthoalign Plus System | Orthalign, Inc. | 2013 | — |
| −6 | K140331 | Orthalign Plus System | Orthalign, Inc. | 2014 | — |
| −5 | K153237 | OrthAlign Plus System | Orthalign, Inc. | 2016 | — |
| −4 | K162962 | OrthAlign Plus System | Orthalign, Inc. | 2017 | — |
| −3 | K171780 | OrthAlign Plus System | Orthalign, Inc. | 2017 | — |
| −2 | K172462 | OrthAlign Plus System | Orthalign, Inc. | 2017 | — |
| −1 | K203115 | ARVIS Surgical Navigation System | Insight Medical Systems, Inc. | 2021 | 2 |
| 0 (this device) | K243980 | ARVIS Surgical Navigation System | Kico Knee Innovation Company Pty Limited | 2025 | — |
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 |
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 SBF? 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 SBF device
- #1 K193559 NextAR TKA Platformscore 20.3 · 10 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K203115 | ARVIS Surgical Navigation SystemSummary page 5…21 CFR 882.4560 – Stereotaxic Instrument Classification Name: Orthopedic Augmented Reality Product Code: SBF 3. Predicate Device 510(k) Number: K203115 Trade Name: ARVIS® Surgical Navigation System Submitter: Insight Medical Systems, Inc. Product Cod… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 13, 2026 | Class II | Z-2957-2026 | Device Design | Due to an internal sensor issue, image displayed with eyepiece may appear tilted relative to the eyepiece housing |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 8 of the 53 ancestors have a recall of any class.
- 1 other device also cites its predicate K203115.
How does its category compare?
All SBF devicesSBF Orthopedic Augmented Reality: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · SBF
13in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · SBF
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · SBF
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · SBF
1in 2025
MAUDE reports naming product code SBF, 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 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 4 | 162 | 0 | 0 |
| 2022 | 7 | 234 | 0 | 0 |
| 2023 | 7 | 104 | 0 | 0 |
| 2024 | 6 | 89 | 0 | 0 |
| 2025 | 13 | 90 | 1 | 1 |
| 2026 | 3 | 123 | 1 | — |
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…
Read the full statement (141 words)
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
• Unicompartrnental Knee Arthroplasty: Tibial Transverse Resection
• Hip Arthroplasty
The ARVIS head mounted display is for displaying augmented reality visualization and information to the user intraoperatively. The augmented/ virtual displayed information should not be relied upon solely for absolute positional/alignment information and should always be used in conjunction with the displayed stereotaxic information.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243980 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243980: 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/K243980
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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