510(k) · Cleared
ClearedNavitrak System-Optical Option, Model 900.004
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 Aug 3, 2000 after a 28-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 of the 428 devices in its family, counting itself, have a Class I recall. 427 later devices descend from it.
- Decided
- Aug 3, 2000
- Review
- 28 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 0
427 later devices descend from it, 3 citing it directly. 5 of the 428 devices in this family, counting this one, have a Class I recall.
- This deviceK002053 Navitrak System-Optical Option, Model 900.004Orthosoft, Inc. · 2000
- Descendant · cites it directly · 363 of its ownK021760 Navitrack System-Optical TKR CT-Less, Model 900.120Orthosoft, Inc. · 2002
- Descendant · 2 generations on · 342 of its ownK043536 Navitrack System - S&N Image Free KneeOrthosoft, Inc. · 2005
- Descendant · 2 generations on · 149 of its ownK031196 Surgetics Ortho Kneelogics Navigation SystemPraxim · 2005
- Descendant · 3 generations on · 147 of its ownK060282 Total Knee Surgetics Navigation SystemPraxim S.A · 2006
- Descendant · 3 generations on · 128 of its ownK060556 Brigit Surgical DeviceZimmer, Inc. · 2006
Showing 5 of 427 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 427 · See all- K021760Navitrack System-Optical TKR CT-Less, Model 900.120Orthosoft, Inc. · 2002 · cites it directly363descendants
- K043536Navitrack System - S&N Image Free KneeOrthosoft, Inc. · 2005 · 2 generations on342descendants
- K031196Surgetics Ortho Kneelogics Navigation SystemPraxim · 2005 · 2 generations on149descendants
- K060282Total Knee Surgetics Navigation SystemPraxim S.A · 2006 · 3 generations on147descendants
- K060556Brigit Surgical DeviceZimmer, Inc. · 2006 · 3 generations on128descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | 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 | — |
| +2 | K043536 | Navitrack System - S&N Image Free Knee | Orthosoft, Inc. | 2005 | — |
| +2 | K031196 | Surgetics Ortho Kneelogics Navigation System | Praxim | 2005 | — |
| +3 | K060282 | Total Knee Surgetics Navigation System | Praxim S.A | 2006 | — |
| +3 | K060556 | Brigit Surgical Device | Zimmer, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 4 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 6 | 0 |
| 2007 | 6 | 0 |
| 2008 | 6 | 0 |
| 2009 | 9 | 0 |
| 2010 | 10 | 0 |
| 2011 | 8 | 0 |
| 2012 | 8 | 0 |
| 2013 | 5 | 0 |
| 2014 | 9 | 0 |
| 2015 | 10 | 1 |
| 2016 | 8 | 0 |
| 2017 | 30 | 0 |
| 2018 | 12 | 1 |
| 2019 | 22 | 1 |
| 2020 | 31 | 1 |
| 2021 | 28 | 1 |
| 2022 | 26 | 0 |
| 2023 | 47 | 0 |
| 2024 | 38 | 0 |
| 2025 | 50 | 0 |
| 2026 | 48 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (427)
See all 4273 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 · 6 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
- K172444ROSA BRAIN (v3.0.0.5)Medtech S.A · 2018 · 7 generations on · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 8 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K182417ROSA ONE Brain ApplicationMedtech S.A · 2019 · 8 generations on · ◆ in the 2019 descendants bar of FIG. 11 Class I recall
- K200511ROSA ONE Brain applicationMedtech S.A · 2020 · 9 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K021760 (Orthosoft, Inc., 2002) has gone furthest, with 363 descendants of its own.
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 | — |
https://510kreport.com/device/K002053 · printed Nov 6, 2026
Cite this page
510(k) Report. “K002053: Navitrak System-Optical Option, Model 900.004.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002053
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026