510(k) · Cleared
Recalled · Class II · 2009Navitrack System-OS Knee Universal, Model Pro-05002
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthosoft, Inc. · HAW Neurological Stereotaxic Instrument
Cleared on Apr 28, 2006 as substantially equivalent to K021760 (Orthosoft, Inc., 2002) and 1 other predicate after a 77-day review. Its family tree reaches back 3 generations to 2000. 91 later devices descend from it. It has been recalled 3 times.
- Decided
- Apr 28, 2006
- Review
- 77 days
- Class
- Class II
- Product code
- HAW
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 3 generations to K002053 (2000). 4 ancestors in all. 91 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK002053 Navitrak System-Optical Option, Model 900.004Orthosoft, Inc. · 2000
- 2 generations backK021760 Navitrack System-Optical TKR CT-Less, Model 900.120Orthosoft, Inc. · 2002
- 1 generation backK043536 Navitrack System - S&N Image Free KneeOrthosoft, Inc. · 2005
- This deviceK060336 Navitrack System-OS Knee Universal, Model Pro-05002Orthosoft, Inc. · 2006
- Descendant · cites it directly · 79 of its ownK071714 Navitrack System - OS Unicondylar Knee Universal, Model# Pro-06003Orthosoft, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 78 of its ownK072806 Mako Surgical Tactile Guidance System (TGS)Mako Surgical Corp. · 2008 · Recalled
- Descendant · 3 generations on · 76 of its ownK081867 Mako Surgical Tactile Guidance System Version 2.0Mako Surgical Corp. · 2008 · Recalled
- Descendant · 4 generations on · 46 of its ownK112507 Restoris Partial Knee Application (Pka), Rio Standard SystemMako Surgical Corporation · 2012 · Recalled
- Descendant · 5 generations on · 44 of its ownK143752 Total Knee Application (TKA)Mako Surgical Corp. · 2015 · Recalled
Showing 5 of 91 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 91 · See all- K071714Navitrack System - OS Unicondylar Knee Universal, Model# Pro-06003Orthosoft, Inc. · 2007 · cites it directly79descendants
- K072806Mako Surgical Tactile Guidance System (TGS)Mako Surgical Corp. · 2008 · 2 generations on78descendants
- K081867Mako Surgical Tactile Guidance System Version 2.0Mako Surgical Corp. · 2008 · 3 generations on76descendants
- K112507Restoris Partial Knee Application (Pka), Rio Standard SystemMako Surgical Corporation · 2012 · 4 generations on46descendants
- K143752Total Knee Application (TKA)Mako Surgical Corp. · 2015 · 5 generations on44descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K002053 | Navitrak System-Optical Option, Model 900.004 | Orthosoft, Inc. | 2000 | — |
| −2 | K021760 | Navitrack System-Optical TKR CT-Less, Model 900.120 | Orthosoft, Inc. | 2002 | — |
| −1 | K043536 | Navitrack System - S&N Image Free Knee | Orthosoft, Inc. | 2005 | — |
| 0 (this device) | K060336 | Navitrack System-OS Knee Universal, Model Pro-05002 | Orthosoft, Inc. | 2006 | — |
| +1 | K071714 | Navitrack System - OS Unicondylar Knee Universal, Model# Pro-06003 | Orthosoft, Inc. | 2007 | 2 |
| +2 | K072806 | Mako Surgical Tactile Guidance System (TGS) | Mako Surgical Corp. | 2008 | 1 |
| +3 | K081867 | Mako Surgical Tactile Guidance System Version 2.0 | Mako Surgical Corp. | 2008 | 2 |
| +4 | K112507 | Restoris Partial Knee Application (Pka), Rio Standard System | Mako Surgical Corporation | 2012 | 6 |
| +5 | K143752 | Total Knee Application (TKA) | Mako Surgical Corp. | 2015 | 2 |
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 |
|---|---|---|
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 4 | 0 |
| 2016 | 1 | 0 |
| 2017 | 7 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 4 | 0 |
| 2021 | 4 | 0 |
| 2022 | 9 | 0 |
| 2023 | 11 | 0 |
| 2024 | 11 | 0 |
| 2025 | 13 | 0 |
| 2026 | 7 | 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 HAW? 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 HAW device
- #1 K253856 Geniant Cranial (Navigated Neurosurgical…score 15.0 · 11 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 |
|---|---|---|---|
| * | K021760 | Navitrack System-Optical TKR CT-Less, Model 900.120Summary page 1…vice Classification Name: Stereotaxic Instrument (84 HAW); 21 CFR § 882.4560 Predicate Devices: 1) Navitrack® System - Optical TKR CT-Less; from Orthosoft Inc; 510(k) # K021760 2) Navitrack System - S&N Image Free Knee; from Orthosoft Inc; 5 10(k) # K043536 Device Description: Identically as in the predi… | 2002 |
| * | K043536 | Navitrack System - S&N Image Free KneeSummary page 1…dicate Devices: 1) Navitrack® System - Optical TKR CT-Less; from Orthosoft Inc; 510(k) # K021760 2) Navitrack System - S&N Image Free Knee; from Orthosoft Inc; 5 10(k) # K043536 Device Description: Identically as in the predicates, the Navitrack® System - OS Knee Universal device consists of software, a c… | 2005 |
What descends from it? (91)
See all 913 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 2, 2009 | Not classified | Z-0558-2010 | Device Design | The power cord female receptacle is not recessed sufficiently and may present a shock hazard. |
| Oct 28, 2008 | Class II | Z-2076-2017 | Software design | Zimmer CAS voluntarily conducted a retrospective recall of the Navitrack System OS Knee Universal software versions 2.2.0.82, 2.2.1.3, 2.1.6.0.2, D.54 and A.42 due to software issues resulting in erros and discrepancies . |
| Jun 20, 2008 | Class III | Z-2075-2017 | Software design | ZIMMER CAS voluntarily conducted a retrospective recall of the Navitrack System - OS Knee Universal, due to software anomalies which were corrected with a new revision in version 2.2.1.3. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 1 company; a new generation was cleared every 2.1 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K071714 (Orthosoft, Inc., 2007) has gone furthest, with 79 descendants of its own.
- 3 other devices also cite its predicate K021760.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HAW
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HAW
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HAW
2in 2025
Class I (9 since 2007) Class II/III not classified
Adverse event reports per year · HAW
3,425in 2025
MAUDE reports naming product code HAW, 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 | 15 | 107 | 2 | 49 |
| 2008 | 12 | 112 | 10 | 53 |
| 2009 | 8 | 221 | 6 | 96 |
| 2010 | 6 | 138 | 28 | 299 |
| 2011 | 4 | 66 | 5 | 1,725 |
| 2012 | 8 | 178 | 4 | 986 |
| 2013 | 3 | 172 | 6 (1) | 1,290 |
| 2014 | 5 | 238 | 5 | 1,606 |
| 2015 | 10 | 232 | 3 | 1,767 |
| 2016 | 9 | 175 | 5 | 1,828 |
| 2017 | 7 | 226 | 2 | 3,505 |
| 2018 | 6 | 112 | 2 (2) | 4,439 |
| 2019 | 10 | 147 | 4 (1) | 6,062 |
| 2020 | 5 | 88 | 1 | 3,480 |
| 2021 | 9 | 168 | 4 (2) | 2,827 |
| 2022 | 7 | 128 | 1 | 1,929 |
| 2023 | 14 | 142 | 4 (1) | 2,510 |
| 2024 | 7 | 107 | 2 (2) | 3,755 |
| 2025 | 9 | 163 | 2 | 3,425 |
| 2026 | 5 | 162 | 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/K060336 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060336: Navitrack System-OS Knee Universal, Model Pro-05002.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060336
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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