510(k) · Cleared
Recalled · Class II · 2022Navitrack System - OS Knee Universal, Cas Same Incision Tibia Reference
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer Cas · OLO Orthopedic Stereotaxic Instrument
Cleared on Mar 24, 2011 as substantially equivalent to K060336 (Orthosoft, Inc., 2006) after a 76-day review. Its family tree reaches back 4 generations to 2000. 9 later devices descend from it. It has been recalled 2 times.
- Decided
- Mar 24, 2011
- Review
- 76 days
- Class
- Class II
- Product code
- OLO
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 4 generations to K002053 (2000). 5 ancestors in all. 9 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK002053 Navitrak System-Optical Option, Model 900.004Orthosoft, Inc. · 2000
- 3 generations backK021760 Navitrack System-Optical TKR CT-Less, Model 900.120Orthosoft, Inc. · 2002
- 2 generations backK043536 Navitrack System - S&N Image Free KneeOrthosoft, Inc. · 2005
- 1 generation backK060336 Navitrack System-OS Knee Universal, Model Pro-05002Orthosoft, Inc. · 2006 · Recalled
- This deviceK110054 Navitrack System - OS Knee Universal, Cas Same Incision Tibia…Zimmer Cas · 2011
- Descendant · cites it directly · 8 of its ownK202750 Knee+Pixee Medical · 2021
- Descendant · 2 generations on · 7 of its ownK220104 Knee+Pixee Medical · 2022
- Descendant · 3 generations on · 5 of its ownK230789 Knee+Pixee Medical · 2023
- Descendant · 4 generations on · 4 of its ownK233899 Knee+Pixee Medical · 2024
- Descendant · 5 generations on · 3 of its ownK243975 Knee+Pixee Medical · 2025
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K202750Knee+Pixee Medical · 2021 · cites it directly8descendants
- K220104Knee+Pixee Medical · 2022 · 2 generations on7descendants
- K230789Knee+Pixee Medical · 2023 · 3 generations on5descendants
- K233899Knee+Pixee Medical · 2024 · 4 generations on4descendants
- K243975Knee+Pixee Medical · 2025 · 5 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K002053 | Navitrak System-Optical Option, Model 900.004 | Orthosoft, Inc. | 2000 | — |
| −3 | K021760 | Navitrack System-Optical TKR CT-Less, Model 900.120 | Orthosoft, Inc. | 2002 | — |
| −2 | K043536 | Navitrack System - S&N Image Free Knee | Orthosoft, Inc. | 2005 | — |
| −1 | K060336 | Navitrack System-OS Knee Universal, Model Pro-05002 | Orthosoft, Inc. | 2006 | 3 |
| 0 (this device) | K110054 | Navitrack System - OS Knee Universal, Cas Same Incision Tibia Reference | Zimmer Cas | 2011 | — |
| +1 | K202750 | Knee+ | Pixee Medical | 2021 | — |
| +2 | K220104 | Knee+ | Pixee Medical | 2022 | — |
| +3 | K230789 | Knee+ | Pixee Medical | 2023 | — |
| +4 | K233899 | Knee+ | Pixee Medical | 2024 | — |
| +5 | K243975 | Knee+ | Pixee Medical | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 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 |
|---|---|---|---|
| * | K060336 | Navitrack System-OS Knee Universal, Model Pro-05002Summary page 1…dic Stereotaxic Instrument (OLO); 21 CFR § 882.4560 Predicate Device: Navitrack® System - OS Knee Universal; from Orthosoft Inc. (name changed to Zimmer CAS); 5 10(k) # K060336 Device Description: The Navitrack® System - OS Knee Universal device consists of software, a computer workstation, an optical tr… | 2006 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K202750 | Knee+ | 2021 | 8 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 7, 2022 | Class II | Z-0721-2022 | Under Investigation by firm | The product was released for distribution without passing sterilization results, which could potentially lead to insufficient sterility of the product. The highest severity risk is infection leading to surgical intervention. |
| Oct 6, 2011 | Class II | Z-1881-2017 | Software design | Zimmer CAS voluntarily conducted a retrospective recall of the Navitrack System - OS Knee Universal software ORTHOsoft-UniTkr-2.3.2.6, due to a calibration sequence crash. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 2.4 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K202750 (Pixee Medical, 2021) has gone furthest, with 8 descendants of its own.
- 2 other devices also cite its predicate K060336.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Navitrack® System - OS Knee Universal is indicated for use as a stereotaxic instrument to assist in the positioning of Total Knee Replacement components intra-operatively.
It is a computer controlled image-guidance system equipped with a three-dimensional tracking sub-system. It is intended to assist the surgeon in determining reference alignment axes in relation to anatomical landmarks, and in precisely positioning the alignment instruments relative to these axes by displaying their locations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110054 · printed Nov 5, 2026
Cite this page
510(k) Report. “K110054: Navitrack System - OS Knee Universal, Cas Same Incision Tibia Reference.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K110054
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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