510(k) · Cleared
Recalled · 2007Navitrack System: Total Hip Replacement CT-Free Cup, Model 900.204
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 May 23, 2003 as substantially equivalent to K022364 (Orthosoft, Inc., 2003) after a 70-day review. Its family tree reaches back 2 generations to 2000. 46 later devices descend from it. It has been recalled once.
- Decided
- May 23, 2003
- Review
- 70 days
- Class
- Class II
- Product code
- HAW
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K002053 (2000). 3 ancestors in all. 46 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK002053 Navitrak System-Optical Option, Model 900.004Orthosoft, Inc. · 2000
- 1 generation backK022364 Navitrack System Total Hip Replacement,Model 900.200Orthosoft, Inc. · 2003
- This deviceK030827 Navitrack System: Total Hip Replacement CT-Free Cup, Model 900.204Orthosoft, Inc. · 2003
- Descendant · cites it directly · 41 of its ownK041369 Navitrack System - S&N Image Free Hip, Model Pro-03017Orthosoft, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 31 of its ownK130387 Orthoalign Plus SystemOrthalign, Inc. · 2013
- Descendant · 2 generations on · 29 of its ownK140331 Orthalign Plus SystemOrthalign, Inc. · 2014
- Descendant · 3 generations on · 18 of its ownK153237 OrthAlign Plus SystemOrthalign, Inc. · 2016
- Descendant · 4 generations on · 15 of its ownK162962 OrthAlign Plus SystemOrthalign, Inc. · 2017
Showing 5 of 46 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 46 · See all- K041369Navitrack System - S&N Image Free Hip, Model Pro-03017Orthosoft, Inc. · 2004 · cites it directly41descendants
- K130387Orthoalign Plus SystemOrthalign, Inc. · 2013 · 2 generations on31descendants
- K140331Orthalign Plus SystemOrthalign, Inc. · 2014 · 2 generations on29descendants
- K153237OrthAlign Plus SystemOrthalign, Inc. · 2016 · 3 generations on18descendants
- K162962OrthAlign Plus SystemOrthalign, Inc. · 2017 · 4 generations on15descendants
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 | K022364 | Navitrack System Total Hip Replacement,Model 900.200 | Orthosoft, Inc. | 2003 | — |
| 0 (this device) | K030827 | Navitrack System: Total Hip Replacement CT-Free Cup, Model 900.204 | Orthosoft, Inc. | 2003 | — |
| +1 | K041369 | Navitrack System - S&N Image Free Hip, Model Pro-03017 | Orthosoft, Inc. | 2004 | 1 |
| +2 | K130387 | Orthoalign Plus System | Orthalign, Inc. | 2013 | — |
| +2 | K140331 | Orthalign Plus System | Orthalign, Inc. | 2014 | — |
| +3 | K153237 | OrthAlign Plus System | Orthalign, Inc. | 2016 | — |
| +4 | K162962 | OrthAlign Plus System | Orthalign, Inc. | 2017 | — |
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 |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 8 | 0 |
| 2019 | 3 | 0 |
| 2020 | 8 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 5 | 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? (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 |
|---|---|---|---|
| * | K022364 | Navitrack System Total Hip Replacement,Model 900.200 | 2003 |
What descends from it? (46)
See all 462 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 |
|---|---|---|---|---|
| Aug 6, 2007 | Not classified | Z-2445-2008 | Device Design | Inadequate weld on tracker, knob oversized and poor thread design on attachment screw results in seizing. The instrument may break during use, resulting in surgical delay and an increased risk of infection. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 3 years and passes through 1 company; a new generation was cleared every 2.5 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K041369 (Orthosoft, Inc., 2004) has gone furthest, with 41 descendants of its own.
- 4 other devices also cite its predicate K022364.
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 NavitrackTMSystem - Total Hip Replacement CT-Free Cup is indicated for use as a stereotaxic instrument to assist in the positioning of hip replacement components.
It is a computer controlled image-guidance system equipped with a three-dimensional tracking sub-system. It is intended to assist in precisely positioning hip replacement components intra-operatively by displaying their positions relative to the joint’s alignment axes as based on user-identified anatomical landmarks.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030827 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030827: Navitrack System: Total Hip Replacement CT-Free Cup, Model 900.204.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030827
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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