510(k) · Cleared
ClearedNavio
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Blue Belt Technologies, Inc. · OLO Orthopedic Stereotaxic Instrument
Cleared on May 19, 2016 as substantially equivalent to K152574 (Blue Belt Technologies, Inc., 2015) after an 83-day review. Its family tree reaches back 13 generations to 1991. 18 later devices descend from it.
- Decided
- May 19, 2016
- Review
- 83 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K905070 (1991). 42 ancestors in all, the oldest K861692 (1986). 18 later devices descend from it, 1 citing it directly.
- Root · 13 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 9 generations between
- 3 generations backK140596 NAVIOBlue Belt Technologies, Inc. · 2014
- 2 generations backK143668 NavioBlue Belt Technologies, Inc. · 2015
- 1 generation backK152574 NavioBlue Belt Technologies, Inc. · 2015
- This deviceK160537 NavioBlue Belt Technologies, Inc. · 2016
- Descendant · cites it directly · 17 of its ownK170360 NAVIOBlue Belt Technologies, Inc. · 2017
- Descendant · 2 generations on · 16 of its ownK180271 NAVIO™ Surgical System (NAVIO system)Blue Belt Technologies, Inc. · 2018
- Descendant · 3 generations on · 15 of its ownK191223 NAVIOBlue Belt Technologies, Inc. · 2019
- Descendant · 4 generations on · 14 of its ownK193120 Real Intelligence CoriBlue Belt Technologies, Inc. · 2020
- Descendant · 4 generations on · 13 of its ownK201022 Real Intelligence Cori (Cori)Blue Belt Technologies, Inc. · 2020
Show all 13 generations
- Root · 13 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 12 generations backK961168 ViewpointPhilips Medical Systems (Cleveland), Inc. · 1996
- 11 generations backK963221 Optical Digitizer Option for View PointPhilips Medical Systems (Cleveland), Inc. · 1997
- 10 generations backK970604 Viewpoint - 3.0 SoftwarePhilips Medical Systems (Cleveland), Inc. · 1997
- 9 generations backK984298 Z Kat Flurotactic Guidance System MkiZ-Kat, Inc. · 1999
- 8 generations backK013025 Modification to Flourolab PlusZ-Kat, Inc. · 2001
- 7 generations backK031337 Acumen Surgical Navigation SystemBiomet, Inc. · 2003
- 6 generations backK072806 Mako Surgical Tactile Guidance System (TGS)Mako Surgical Corp. · 2008 · Recalled
- 5 generations backK081867 Mako Surgical Tactile Guidance System Version 2.0Mako Surgical Corp. · 2008 · Recalled
- 4 generations backK121936 NaviopfsBlue Belt Technologies, Inc. · 2012 · Recalled
- 3 generations backK140596 NAVIOBlue Belt Technologies, Inc. · 2014
- 2 generations backK143668 NavioBlue Belt Technologies, Inc. · 2015
- 1 generation backK152574 NavioBlue Belt Technologies, Inc. · 2015
- This deviceK160537 NavioBlue Belt Technologies, Inc. · 2016
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K170360NAVIOBlue Belt Technologies, Inc. · 2017 · cites it directly17descendants
- K180271NAVIO™ Surgical System (NAVIO system)Blue Belt Technologies, Inc. · 2018 · 2 generations on16descendants
- K191223NAVIOBlue Belt Technologies, Inc. · 2019 · 3 generations on15descendants
- K193120Real Intelligence CoriBlue Belt Technologies, Inc. · 2020 · 4 generations on14descendants
- K201022Real Intelligence Cori (Cori)Blue Belt Technologies, Inc. · 2020 · 4 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K905070 | Vistar | Philips Medical Systems (Cleveland), Inc. | 1991 | — |
| −12 | K961168 | Viewpoint | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| −11 | K963221 | Optical Digitizer Option for View Point | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −10 | K970604 | Viewpoint - 3.0 Software | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −9 | K984298 | Z Kat Flurotactic Guidance System Mki | Z-Kat, Inc. | 1999 | — |
| −8 | K013025 | Modification to Flourolab Plus | Z-Kat, Inc. | 2001 | — |
| −7 | K031337 | Acumen Surgical Navigation System | Biomet, Inc. | 2003 | — |
| −6 | K072806 | Mako Surgical Tactile Guidance System (TGS) | Mako Surgical Corp. | 2008 | 1 |
| −5 | K081867 | Mako Surgical Tactile Guidance System Version 2.0 | Mako Surgical Corp. | 2008 | 2 |
| −4 | K121936 | Naviopfs | Blue Belt Technologies, Inc. | 2012 | 2 |
| −3 | K140596 | NAVIO | Blue Belt Technologies, Inc. | 2014 | — |
| −2 | K143668 | Navio | Blue Belt Technologies, Inc. | 2015 | — |
| −1 | K152574 | Navio | Blue Belt Technologies, Inc. | 2015 | — |
| 0 (this device) | K160537 | Navio | Blue Belt Technologies, Inc. | 2016 | — |
| +1 | K170360 | NAVIO | Blue Belt Technologies, Inc. | 2017 | — |
| +2 | K180271 | NAVIO™ Surgical System (NAVIO system) | Blue Belt Technologies, Inc. | 2018 | — |
| +3 | K191223 | NAVIO | Blue Belt Technologies, Inc. | 2019 | — |
| +4 | K193120 | Real Intelligence Cori | Blue Belt Technologies, Inc. | 2020 | — |
| +4 | K201022 | Real Intelligence Cori (Cori) | Blue Belt Technologies, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 3 | 0 |
| 2002 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K152574 | NavioSummary page 4…, NPJ, JWH Common/Usual Name Orthopedic Sterotaxic Instrument Trade/Proprietary Name Navio® Predicate Device(s) Navio® (K152574) Reason for Submission Expanded indications for use to include total knee arth… | 2015 |
What descends from it? (18)
See all 181 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170360 | NAVIO | 2017 | 17 |
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 25 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- 9 of the 42 ancestors have a recall of any class.
- Of its descendants, K170360 (Blue Belt Technologies, Inc., 2017) has gone furthest, with 17 descendants 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. 2016, 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 Navio system is intended to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.
The Navio system is indicated for use in surgical knee procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be determined. These procedures include unicondylar knee replacement (UKR), patellofemoral arthroplasty (PFA), and total knee arthroplasty (TKA).
The Navio system is indicated for use with cemented implants only.
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/K160537 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160537: Navio.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160537
Report an extraction error
Are you the manufacturer?
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