510(k) · Cleared
ClearedNaviswiss Hip Navigation System
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 Jun 10, 2020 as substantially equivalent to K162364 (Intellijoint Surgical, Inc., 2017) after a 216-day review. Its family tree reaches back 10 generations to 2001. 1 later device descends from it.
- Decided
- Jun 10, 2020
- Review
- 216 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K010612 (2001). 24 ancestors in all, the oldest K983831 (1999). 1 later device descends from it, 1 citing it directly.
- Root · 10 generations backK010612 Vectorvision KneeBrainlab AG · 2001
- 6 generations between
- 3 generations backK133759 Intellijoint HipIntellijoint Surgical, Inc. · 2014
- 2 generations backK151364 Intellijoint HIP (tm) SystemIntellijoint Surgical, Inc. · 2015
- 1 generation backK162364 Intellijoint HIP Generation 2A SystemIntellijoint Surgical, Inc. · 2017
- This deviceK193094 Naviswiss Hip Navigation SystemNaviswiss AG · 2020
- Descendant · cites it directly · 0 of its ownK223351 Naviswiss KneeNaviswiss AG · 2023
Show all 10 generations
- Root · 10 generations backK010612 Vectorvision KneeBrainlab AG · 2001
- 9 generations backK021306 Vectorvision CT-Free KneeBrainlab AG · 2002
- 8 generations backK040368 Vectorvision Hip 3.0Brainlab AG · 2004
- 7 generations backK052213 Navigation SW Hip 3.1 on CIBrainlab AG · 2005
- 6 generations backK060468 Vectorvision HipBrainlab AG · 2006
- 5 generations backK083483 Brainlab Hip Unlimited, CI Hip UnlimitedBrainlab AG · 2009
- 4 generations backK110021 Dash HipBrainlab AG · 2011
- 3 generations backK133759 Intellijoint HipIntellijoint Surgical, Inc. · 2014
- 2 generations backK151364 Intellijoint HIP (tm) SystemIntellijoint Surgical, Inc. · 2015
- 1 generation backK162364 Intellijoint HIP Generation 2A SystemIntellijoint Surgical, Inc. · 2017
- This deviceK193094 Naviswiss Hip Navigation SystemNaviswiss AG · 2020
Most influential descendants
Showing 1 of 1 · See all- K223351Naviswiss KneeNaviswiss AG · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K010612 | Vectorvision Knee | Brainlab AG | 2001 | — |
| −9 | K021306 | Vectorvision CT-Free Knee | Brainlab AG | 2002 | — |
| −8 | K040368 | Vectorvision Hip 3.0 | Brainlab AG | 2004 | — |
| −7 | K052213 | Navigation SW Hip 3.1 on CI | Brainlab AG | 2005 | — |
| −6 | K060468 | Vectorvision Hip | Brainlab AG | 2006 | — |
| −5 | K083483 | Brainlab Hip Unlimited, CI Hip Unlimited | Brainlab AG | 2009 | — |
| −4 | K110021 | Dash Hip | Brainlab AG | 2011 | — |
| −3 | K133759 | Intellijoint Hip | Intellijoint Surgical, Inc. | 2014 | — |
| −2 | K151364 | Intellijoint HIP (tm) System | Intellijoint Surgical, Inc. | 2015 | — |
| −1 | K162364 | Intellijoint HIP Generation 2A System | Intellijoint Surgical, Inc. | 2017 | — |
| 0 (this device) | K193094 | Naviswiss Hip Navigation System | Naviswiss AG | 2020 | — |
| +1 | 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 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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? (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 |
|---|---|---|---|
| * | K162364 | Intellijoint HIP Generation 2A SystemSummary page 4…ment Classification name: Orthopedic Stereotaxic Instrument Product code: OLO Predicate Device: Substantial Equivalence is claimed with the device, K162364 “intellijoint HIP Generation 2A Sys- tem”, manufactured by Intellijoint Surgical Inc. on the basis of equivalent intended use / i… | 2017 |
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 |
|---|---|---|---|
| K223351 | Naviswiss Knee | 2023 | 0 |
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 19 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
- 4 of the 24 ancestors have a recall of any class.
- Of its descendants, K223351 (Naviswiss AG, 2023) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K162364.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 Hip 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 is only compatible with acetabular cup impactors that have a parallel and straight segment. The system aids the surgeon in performing intra-operative measurements including…
Read the full statement (99 words)
The Naviswiss Hip 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 is only compatible with acetabular cup impactors that have a parallel and straight segment. The system aids the surgeon in performing intra-operative measurements including measurements of leg length, offset, and cup inclination/anteversion.
An example of a stereotaxic orthopedic surgical procedure includes Total Hip Arthroplasty: Lateral/Supine.
The equipment is intended for use by trained surgeons in operating theaters.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193094 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193094: Naviswiss Hip 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/K193094
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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