510(k) · Cleared
Recalled · Class II · 2020Naviopfs
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 Nov 30, 2012 as substantially equivalent to K081867 (Mako Surgical Corp., 2008) and 1 other predicate after a 151-day review. Its family tree reaches back 9 generations to 1991. 22 later devices descend from it. It has been recalled 2 times.
- Decided
- Nov 30, 2012
- Review
- 151 days
- Class
- Class II
- Product code
- OLO
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 9 generations to K905070 (1991). 38 ancestors in all, the oldest K861692 (1986). 22 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 5 generations between
- 3 generations backK031337 Acumen Surgical Navigation SystemBiomet, Inc. · 2003
- 2 generations backK072806 Mako Surgical Tactile Guidance System (TGS)Mako Surgical Corp. · 2008 · Recalled
- 1 generation backK081867 Mako Surgical Tactile Guidance System Version 2.0Mako Surgical Corp. · 2008 · Recalled
- This deviceK121936 NaviopfsBlue Belt Technologies, Inc. · 2012
- Descendant · cites it directly · 21 of its ownK140596 NAVIOBlue Belt Technologies, Inc. · 2014
- Descendant · 2 generations on · 20 of its ownK143668 NavioBlue Belt Technologies, Inc. · 2015
- Descendant · 3 generations on · 19 of its ownK152574 NavioBlue Belt Technologies, Inc. · 2015
- Descendant · 4 generations on · 18 of its ownK160537 NavioBlue Belt Technologies, Inc. · 2016
- Descendant · 5 generations on · 17 of its ownK170360 NAVIOBlue Belt Technologies, Inc. · 2017
Show all 9 generations
- Root · 9 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 8 generations backK961168 ViewpointPhilips Medical Systems (Cleveland), Inc. · 1996
- 7 generations backK963221 Optical Digitizer Option for View PointPhilips Medical Systems (Cleveland), Inc. · 1997
- 6 generations backK970604 Viewpoint - 3.0 SoftwarePhilips Medical Systems (Cleveland), Inc. · 1997
- 5 generations backK984298 Z Kat Flurotactic Guidance System MkiZ-Kat, Inc. · 1999
- 4 generations backK013025 Modification to Flourolab PlusZ-Kat, Inc. · 2001
- 3 generations backK031337 Acumen Surgical Navigation SystemBiomet, Inc. · 2003
- 2 generations backK072806 Mako Surgical Tactile Guidance System (TGS)Mako Surgical Corp. · 2008 · Recalled
- 1 generation backK081867 Mako Surgical Tactile Guidance System Version 2.0Mako Surgical Corp. · 2008 · Recalled
- This deviceK121936 NaviopfsBlue Belt Technologies, Inc. · 2012
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K140596NAVIOBlue Belt Technologies, Inc. · 2014 · cites it directly21descendants
- K143668NavioBlue Belt Technologies, Inc. · 2015 · 2 generations on20descendants
- K152574NavioBlue Belt Technologies, Inc. · 2015 · 3 generations on19descendants
- K160537NavioBlue Belt Technologies, Inc. · 2016 · 4 generations on18descendants
- K170360NAVIOBlue Belt Technologies, Inc. · 2017 · 5 generations on17descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K905070 | Vistar | Philips Medical Systems (Cleveland), Inc. | 1991 | — |
| −8 | K961168 | Viewpoint | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| −7 | K963221 | Optical Digitizer Option for View Point | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −6 | K970604 | Viewpoint - 3.0 Software | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −5 | K984298 | Z Kat Flurotactic Guidance System Mki | Z-Kat, Inc. | 1999 | — |
| −4 | K013025 | Modification to Flourolab Plus | Z-Kat, Inc. | 2001 | — |
| −3 | K031337 | Acumen Surgical Navigation System | Biomet, Inc. | 2003 | — |
| −2 | K072806 | Mako Surgical Tactile Guidance System (TGS) | Mako Surgical Corp. | 2008 | 1 |
| −1 | K081867 | Mako Surgical Tactile Guidance System Version 2.0 | Mako Surgical Corp. | 2008 | 2 |
| 0 (this device) | K121936 | Naviopfs | Blue Belt Technologies, Inc. | 2012 | — |
| +1 | K140596 | NAVIO | Blue Belt Technologies, Inc. | 2014 | — |
| +2 | K143668 | Navio | Blue Belt Technologies, Inc. | 2015 | — |
| +3 | K152574 | Navio | Blue Belt Technologies, Inc. | 2015 | — |
| +4 | K160537 | Navio | Blue Belt Technologies, Inc. | 2016 | — |
| +5 | K170360 | NAVIO | Blue Belt Technologies, Inc. | 2017 | — |
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 |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K081867 | Mako Surgical Tactile Guidance System Version 2.0Summary page 1…t Proprietary Name NavioPFSTM Predicate Device(s) MAKO Surgical Tactile Guidance System v2.O0 ("MAKO RIO') (K081867) The Zimmer (ORTHOsoft) Na v/track®@ System - OS Unicondylar Knee… | 2008 |
| * | K071714 | Navitrack System - OS Unicondylar Knee Universal, Model# Pro-06003Summary page 3…(-MAKO RIO') (KOB81667) OIS Unicondylar Knee Universal (K071 714) Technological The NavioPFS' m System The MAKO RIO uses The Navitrack System - Characteristics… | 2007 |
What descends from it? (22)
See all 221 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140596 | NAVIO | 2014 | 21 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 27, 2020 | Class II | Z-1634-2020 | Device Design | Potential for the NAVIO Soft Tissue Protector to become stuck or bound to the bone pin intraoperatively when inserting the NAVIO bone pins. |
| Apr 11, 2014 | Class II | Z-1575-2014 | Software design | Blue Belt Technologies is conducting a voluntary recall for their Navio PFS system which is used during orthopedic knee surgery. One of the electronic modules inside the computer cart assembly may have a defect in one of its components… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
- 8 of the 38 ancestors have a recall of any class.
- Of its descendants, K140596 (Blue Belt Technologies, Inc., 2014) has gone furthest, with 21 descendants of its own.
- 4 other devices also cite its predicate K081867.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 NavioPF STM 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 NavioPFSTM 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121936 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121936: Naviopfs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121936
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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