510(k) · Cleared
ClearedNavitrack System - S&N Image Free Knee
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 Jan 14, 2005 as substantially equivalent to K021760 (Orthosoft, Inc., 2002) after a 23-day review. Its family tree reaches back 2 generations to 2000. 5 of the 346 devices in its family, counting itself, have a Class I recall. 342 later devices descend from it.
- Decided
- Jan 14, 2005
- Review
- 23 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K002053 (2000). 3 ancestors in all. 342 later devices descend from it, 5 citing it directly. 5 of the 346 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK002053 Navitrak System-Optical Option, Model 900.004Orthosoft, Inc. · 2000
- 1 generation backK021760 Navitrack System-Optical TKR CT-Less, Model 900.120Orthosoft, Inc. · 2002
- This deviceK043536 Navitrack System - S&N Image Free KneeOrthosoft, Inc. · 2005
- Descendant · cites it directly · 128 of its ownK060556 Brigit Surgical DeviceZimmer, Inc. · 2006
- Descendant · 2 generations on · 127 of its ownK092239 Rosa Surgical Device, Model Rosa 1.1Medtech S.A · 2009 · Recalled
- Descendant · 3 generations on · 126 of its ownK101791 Rosa Surgical DeviceMedtech S.A.S · 2010 · Recalled
- Descendant · cites it directly · 126 of its ownK061362 Pigalileo Total Knee Replacement (TKR) SystemPlus Orthopedics AG · 2006
- Descendant · 4 generations on · 109 of its ownK151511 ROSA SpineMedtech S.A · 2016 · Recalled
Showing 5 of 342 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 342 · See all- K060556Brigit Surgical DeviceZimmer, Inc. · 2006 · cites it directly128descendants
- K092239Rosa Surgical Device, Model Rosa 1.1Medtech S.A · 2009 · 2 generations on127descendants
- K101791Rosa Surgical DeviceMedtech S.A.S · 2010 · 3 generations on126descendants
- K061362Pigalileo Total Knee Replacement (TKR) SystemPlus Orthopedics AG · 2006 · cites it directly126descendants
- K151511ROSA SpineMedtech S.A · 2016 · 4 generations on109descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002053 | Navitrak System-Optical Option, Model 900.004 | Orthosoft, Inc. | 2000 | — |
| −1 | K021760 | Navitrack System-Optical TKR CT-Less, Model 900.120 | Orthosoft, Inc. | 2002 | — |
| 0 (this device) | K043536 | Navitrack System - S&N Image Free Knee | Orthosoft, Inc. | 2005 | — |
| +1 | K060556 | Brigit Surgical Device | Zimmer, Inc. | 2006 | — |
| +2 | K092239 | Rosa Surgical Device, Model Rosa 1.1 | Medtech S.A | 2009 | 9 |
| +3 | K101791 | Rosa Surgical Device | Medtech S.A.S | 2010 | 12 |
| +1 | K061362 | Pigalileo Total Knee Replacement (TKR) System | Plus Orthopedics AG | 2006 | — |
| +4 | K151511 | ROSA Spine | Medtech S.A | 2016 | 3 |
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 |
|---|---|---|
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2008 | 5 | 0 |
| 2009 | 8 | 0 |
| 2010 | 7 | 0 |
| 2011 | 5 | 0 |
| 2012 | 7 | 0 |
| 2013 | 5 | 0 |
| 2014 | 8 | 0 |
| 2015 | 8 | 1 |
| 2016 | 6 | 0 |
| 2017 | 24 | 0 |
| 2018 | 7 | 1 |
| 2019 | 20 | 1 |
| 2020 | 24 | 1 |
| 2021 | 23 | 1 |
| 2022 | 22 | 0 |
| 2023 | 38 | 0 |
| 2024 | 35 | 0 |
| 2025 | 43 | 0 |
| 2026 | 41 | 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.
5 devices in this family have a Class I recall. 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? (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 |
|---|---|---|---|
| * | K021760 | Navitrack System-Optical TKR CT-Less, Model 900.120Summary page 1…Device Classification Name: Stereotaxic Instrument (84 HAW); 21 CFR § 882.4560 Predicate Device: Navitrack®0 System - Optical TKR CT-Less; from Orthosoft Inc; 5 10(k) # K021760. Device Description: Identically as in the predicate, the Navitrack®9 System - S&N Image Free Knee device consists of a software… | 2002 |
What descends from it? (342)
See all 3425 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (5 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K151359ROSA BrainMedtech S.A · 2015 · 4 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
- K172444ROSA BRAIN (v3.0.0.5)Medtech S.A · 2018 · 5 generations on · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 6 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K182417ROSA ONE Brain ApplicationMedtech S.A · 2019 · 6 generations on · ◆ in the 2019 descendants bar of FIG. 11 Class I recall
- K200511ROSA ONE Brain applicationMedtech S.A · 2020 · 7 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 5 years and passes through 1 company; a new generation was cleared every 2.4 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K060556 (Zimmer, Inc., 2006) has gone furthest, with 128 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 - S&N Image Free Knee 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/K043536 · printed Nov 4, 2026
Cite this page
510(k) Report. “K043536: Navitrack System - S&N Image Free Knee.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043536
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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