510(k) · Cleared
Recalled · 2009Navitrack System - OS Unicondylar Knee Universal, Model# Pro-06003
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 Jul 20, 2007 as substantially equivalent to K060336 (Orthosoft, Inc., 2006) and 1 other predicate after a 28-day review. Its family tree reaches back 5 generations to 2000. 79 later devices descend from it. It has been recalled 2 times.
- Decided
- Jul 20, 2007
- Review
- 28 days
- Class
- Class II
- Product code
- HAW
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 5 generations to K002053 (2000). 10 ancestors in all. 79 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK002053 Navitrak System-Optical Option, Model 900.004Orthosoft, Inc. · 2000
- 4 generations backK021760 Navitrack System-Optical TKR CT-Less, Model 900.120Orthosoft, Inc. · 2002
- 3 generations backK031196 Surgetics Ortho Kneelogics Navigation SystemPraxim · 2005
- 2 generations backK060282 Total Knee Surgetics Navigation SystemPraxim S.A · 2006
- 1 generation backK062146 Uni Knee Surgetics Navigation SystemPraxim S.A · 2006
- This deviceK071714 Navitrack System - OS Unicondylar Knee Universal, Model# Pro-06003Orthosoft, Inc. · 2007
- Descendant · cites it directly · 78 of its ownK072806 Mako Surgical Tactile Guidance System (TGS)Mako Surgical Corp. · 2008 · Recalled
- Descendant · 2 generations on · 76 of its ownK081867 Mako Surgical Tactile Guidance System Version 2.0Mako Surgical Corp. · 2008 · Recalled
- Descendant · 3 generations on · 46 of its ownK112507 Restoris Partial Knee Application (Pka), Rio Standard SystemMako Surgical Corporation · 2012 · Recalled
- Descendant · 4 generations on · 44 of its ownK143752 Total Knee Application (TKA)Mako Surgical Corp. · 2015 · Recalled
- Descendant · 5 generations on · 38 of its ownK170581 Mako Total Knee ApplicationMako Surgical Corp. · 2017 · Recalled
Showing 5 of 79 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 79 · See all- K072806Mako Surgical Tactile Guidance System (TGS)Mako Surgical Corp. · 2008 · cites it directly78descendants
- K081867Mako Surgical Tactile Guidance System Version 2.0Mako Surgical Corp. · 2008 · 2 generations on76descendants
- K112507Restoris Partial Knee Application (Pka), Rio Standard SystemMako Surgical Corporation · 2012 · 3 generations on46descendants
- K143752Total Knee Application (TKA)Mako Surgical Corp. · 2015 · 4 generations on44descendants
- K170581Mako Total Knee ApplicationMako Surgical Corp. · 2017 · 5 generations on38descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K002053 | Navitrak System-Optical Option, Model 900.004 | Orthosoft, Inc. | 2000 | — |
| −4 | K021760 | Navitrack System-Optical TKR CT-Less, Model 900.120 | Orthosoft, Inc. | 2002 | — |
| −3 | K031196 | Surgetics Ortho Kneelogics Navigation System | Praxim | 2005 | — |
| −2 | K060282 | Total Knee Surgetics Navigation System | Praxim S.A | 2006 | — |
| −1 | K062146 | Uni Knee Surgetics Navigation System | Praxim S.A | 2006 | — |
| 0 (this device) | K071714 | Navitrack System - OS Unicondylar Knee Universal, Model# Pro-06003 | Orthosoft, Inc. | 2007 | — |
| +1 | K072806 | Mako Surgical Tactile Guidance System (TGS) | Mako Surgical Corp. | 2008 | 1 |
| +2 | K081867 | Mako Surgical Tactile Guidance System Version 2.0 | Mako Surgical Corp. | 2008 | 2 |
| +3 | K112507 | Restoris Partial Knee Application (Pka), Rio Standard System | Mako Surgical Corporation | 2012 | 6 |
| +4 | K143752 | Total Knee Application (TKA) | Mako Surgical Corp. | 2015 | 2 |
| +5 | K170581 | Mako Total Knee Application | Mako Surgical Corp. | 2017 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 4 | 0 |
| 2016 | 1 | 0 |
| 2017 | 7 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 4 | 0 |
| 2021 | 3 | 0 |
| 2022 | 8 | 0 |
| 2023 | 9 | 0 |
| 2024 | 10 | 0 |
| 2025 | 12 | 0 |
| 2026 | 6 | 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 |
|---|---|---|---|
| * | K060336 | Navitrack System-OS Knee Universal, Model Pro-05002Summary page 1…evice Classification Name: Stereotaxic Instrument (84 HAW); 21 CFR § 882.4560 Predicate Devices: 1) Navitrack® System - OS Knee Universal; from Orthosoft Inc; 5 10(k) # K060336 2) Uni Knee Surgetics Navigation System; from Praxim; 510(k) # K062146 Device Description: The Navitrack System - OS Unicondylar… | 2006 |
| * | K062146 | Uni Knee Surgetics Navigation SystemSummary page 1…2.4560 Predicate Devices: 1) Navitrack® System - OS Knee Universal; from Orthosoft Inc; 5 10(k) # K060336 2) Uni Knee Surgetics Navigation System; from Praxim; 510(k) # K062146 Device Description: The Navitrack System - OS Unicondylar Knee Universal device consists of software, a computer workstation, an… | 2006 |
What descends from it? (79)
See all 792 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. |
| Aug 19, 2008 | Not classified | Z-0985-2009 | Software design | Incorrect parameters: If the user switches from one surgeon profile to another surgeon profile after completing anatomical landmark acquisition tasks, the application will continue to use the initial surgeon profile parameter values in… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 11 months on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K072806 (Mako Surgical Corp., 2008) has gone furthest, with 78 descendants of its own.
- 2 other devices also cite its predicate K060336.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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 Unicondylar Knee Universal is indicated for use as a
stereotaxic instrument to assist in the positioning of unicondylar 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/K071714 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071714: Navitrack System - OS Unicondylar Knee Universal, Model# Pro-06003.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071714
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