510(k) · Cleared
ClearedNaviswiss Knee
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Naviswiss AG · OLO Orthopedic Stereotaxic Instrument
Cleared on Jan 31, 2023 as substantially equivalent to K193094 (Naviswiss AG, 2020) and 1 other predicate after a 90-day review. Its family tree reaches back 12 generations to 2001.
- Decided
- Jan 31, 2023
- Review
- 90 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K010612 (2001). 41 ancestors in all, the oldest K983831 (1999). No later device cites it as a predicate yet.
- Root · 12 generations backK010612 Vectorvision KneeBrainlab AG · 2001
- 8 generations between
- 3 generations backK162364 Intellijoint HIP Generation 2A SystemIntellijoint Surgical, Inc. · 2017
- 2 generations backK171525 Intellijoint HIP Generation 2B SystemIntellijoint Surgical, Inc. · 2017
- 1 generation backK191507 Intellijoint® Navigation SystemIntellijoint Surgical, Inc. · 2019 · Recalled
- This deviceK223351 Naviswiss KneeNaviswiss AG · 2023
Show all 12 generations
- Root · 12 generations backK010612 Vectorvision KneeBrainlab AG · 2001
- 11 generations backK021306 Vectorvision CT-Free KneeBrainlab AG · 2002
- 10 generations backK040368 Vectorvision Hip 3.0Brainlab AG · 2004
- 9 generations backK052213 Navigation SW Hip 3.1 on CIBrainlab AG · 2005
- 8 generations backK060468 Vectorvision HipBrainlab AG · 2006
- 7 generations backK083483 Brainlab Hip Unlimited, CI Hip UnlimitedBrainlab AG · 2009
- 6 generations backK110021 Dash HipBrainlab AG · 2011
- 5 generations backK133759 Intellijoint HipIntellijoint Surgical, Inc. · 2014
- 4 generations backK151364 Intellijoint HIP (tm) SystemIntellijoint Surgical, Inc. · 2015
- 3 generations backK162364 Intellijoint HIP Generation 2A SystemIntellijoint Surgical, Inc. · 2017
- 2 generations backK171525 Intellijoint HIP Generation 2B SystemIntellijoint Surgical, Inc. · 2017
- 1 generation backK191507 Intellijoint® Navigation SystemIntellijoint Surgical, Inc. · 2019 · Recalled
- This deviceK223351 Naviswiss KneeNaviswiss AG · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K010612 | Vectorvision Knee | Brainlab AG | 2001 | — |
| −11 | K021306 | Vectorvision CT-Free Knee | Brainlab AG | 2002 | — |
| −10 | K040368 | Vectorvision Hip 3.0 | Brainlab AG | 2004 | — |
| −9 | K052213 | Navigation SW Hip 3.1 on CI | Brainlab AG | 2005 | — |
| −8 | K060468 | Vectorvision Hip | Brainlab AG | 2006 | — |
| −7 | K083483 | Brainlab Hip Unlimited, CI Hip Unlimited | Brainlab AG | 2009 | — |
| −6 | K110021 | Dash Hip | Brainlab AG | 2011 | — |
| −5 | K133759 | Intellijoint Hip | Intellijoint Surgical, Inc. | 2014 | — |
| −4 | K151364 | Intellijoint HIP (tm) System | Intellijoint Surgical, Inc. | 2015 | — |
| −3 | K162364 | Intellijoint HIP Generation 2A System | Intellijoint Surgical, Inc. | 2017 | — |
| −2 | K171525 | Intellijoint HIP Generation 2B System | Intellijoint Surgical, Inc. | 2017 | — |
| −1 | K191507 | Intellijoint® Navigation System | Intellijoint Surgical, Inc. | 2019 | 2 |
| 0 (this device) | K223351 | Naviswiss Knee | Naviswiss AG | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 4 | 0 |
| 2003 | 4 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 4 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 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 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? (2)
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 |
|---|---|---|---|
| * | K193094 | Naviswiss Hip Navigation SystemSummary page 4…ber 882.4560 Product Code OLO I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K193094 Naviswiss Hip OLO K191507 Intellijoint Navigation System OLO Device Description Summary 21 CFR 807.92(a)(4) The Naviswiss Knee i… | 2020 |
| * | K191507 | Intellijoint® Navigation SystemSummary page 4…OLO I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K193094 Naviswiss Hip OLO K191507 Intellijoint Navigation System OLO Device Description Summary 21 CFR 807.92(a)(4) The Naviswiss Knee is a surgical navigation sy… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
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 1.8 years on median.
- 6 of the 41 ancestors have a recall of any class.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 Naviswiss Knee Navigation System is a computer-controlled system intended to assist the surgeon in determining reference alignment axes to aid in the positioning of orthopedic implant system components where a reference to a rigid anatomical structure can be identified. The system aids the surgeon in performing intra-operative measurements of femoral and tibial alignment axes to assist in executing the distal femoral and proximal tibial resections. The equipment is intended for use by trained surgeons in operating theaters.
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/K223351 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223351: Naviswiss Knee.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223351
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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