510(k) Report

510(k) · Cleared

Recalled · 2006

Navitrack System - S&N Image Free Hip, Model Pro-03017

K041369510(k) SpecialCleared Jun 22, 200429-day reviewClass II21 CFR 882.4560Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Orthosoft, Inc. · HAW Neurological Stereotaxic Instrument

Cleared on Jun 22, 2004 as substantially equivalent to K030827 (Orthosoft, Inc., 2003) after a 29-day review. Its family tree reaches back 3 generations to 2000. 41 later devices descend from it. It has been recalled once.

Decided
Jun 22, 2004
Review
29 days
Class
Class II
Product code
HAW
Recalls
1
Predicates
1

Its longest line of descent runs back 3 generations to K002053 (2000). 4 ancestors in all. 41 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor2015: 2 descendants cleared2014: 1 descendant cleared2013: 1 descendant cleared2017: 8 descendants cleared2025: 3 descendants cleared2016: 3 descendants cleared2026: 5 descendants cleared2020: 8 descendants cleared2019: 3 descendants cleared2021: 3 descendants cleared2023: 1 descendant cleared2024: 2 descendants cleared2022: 1 descendant clearedK002053 · Navitrak System-Optical Option, Model 900.004 · Orthosoft, Inc. · 2000K022364 · Navitrack System Total Hip Replacement,Model 900.200 · Orthosoft, Inc. · 2003K030827 · Navitrack System: Total Hip Replacement CT-Free Cup, Model 900.204 · Orthosoft, Inc. · 2003 · recalled200020052010201520202025
Other ancestors, by generationDescendants, by generation 3 generations back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 7 descendants3 generations forward: 7 descendants4 generations forward: 5 descendants5 generations forward: 4 descendants6 generations forward: 4 descendants7 generations forward: 7 descendants8 generations forward: 2 descendants9 generations forward: 1 descendant K030827 · Navitrack System: Total Hip Replacement CT-Free Cup, Model 900.204 · Orthosoft, Inc. · 2003 · recalledK022364 · Navitrack System Total Hip Replacement,Model 900.200 · Orthosoft, Inc. · 2003K002053 · Navitrak System-Optical Option, Model 900.004 · Orthosoft, Inc. · 20000+5
  1. Root · 3 generations backK002053 Navitrak System-Optical Option, Model 900.004Orthosoft, Inc. · 2000
  2. 2 generations backK022364 Navitrack System Total Hip Replacement,Model 900.200Orthosoft, Inc. · 2003
  3. 1 generation backK030827 Navitrack System: Total Hip Replacement CT-Free Cup, Model 900.204Orthosoft, Inc. · 2003 · Recalled
  4. This deviceK041369 Navitrack System - S&N Image Free Hip, Model Pro-03017Orthosoft, Inc. · 2004
  5. Descendant · cites it directly · 31 of its ownK130387 Orthoalign Plus SystemOrthalign, Inc. · 2013
  6. Descendant · cites it directly · 29 of its ownK140331 Orthalign Plus SystemOrthalign, Inc. · 2014
  7. Descendant · 2 generations on · 18 of its ownK153237 OrthAlign Plus SystemOrthalign, Inc. · 2016
  8. Descendant · 3 generations on · 15 of its ownK162962 OrthAlign Plus SystemOrthalign, Inc. · 2017
  9. Descendant · 4 generations on · 12 of its ownK171780 OrthAlign Plus SystemOrthalign, Inc. · 2017

Showing 5 of 41 descendants. See all descendants

Descendants cleared per year

2013: 12014: 12015: 22016: 32017: 82019: 32020: 82021: 32022: 12023: 12024: 22025: 32026: 5
2013high 8 (2017) · low 0 (2018)2026

Most influential descendants

Showing 5 of 41 · See all
  • K130387Orthoalign Plus SystemOrthalign, Inc. · 2013 · cites it directly31descendants
  • K140331Orthalign Plus SystemOrthalign, Inc. · 2014 · cites it directly29descendants
  • K153237OrthAlign Plus SystemOrthalign, Inc. · 2016 · 2 generations on18descendants
  • K162962OrthAlign Plus SystemOrthalign, Inc. · 2017 · 3 generations on15descendants
  • K171780OrthAlign Plus SystemOrthalign, Inc. · 2017 · 4 generations on12descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K002053Navitrak System-Optical Option, Model 900.004Orthosoft, Inc.2000—
−2K022364Navitrack System Total Hip Replacement,Model 900.200Orthosoft, Inc.2003—
−1K030827Navitrack System: Total Hip Replacement CT-Free Cup, Model 900.204Orthosoft, Inc.20031
0 (this device)K041369Navitrack System - S&N Image Free Hip, Model Pro-03017Orthosoft, Inc.2004—
+1K130387Orthoalign Plus SystemOrthalign, Inc.2013—
+1K140331Orthalign Plus SystemOrthalign, Inc.2014—
+2K153237OrthAlign Plus SystemOrthalign, Inc.2016—
+3K162962OrthAlign Plus SystemOrthalign, Inc.2017—
+4K171780OrthAlign Plus SystemOrthalign, Inc.2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201410
201520
201630
201780
201930
202080
202130
202210
202310
202420
202530
202650
FIG. 1 — Lineage of K041369, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K253856 Geniant Cranial (Navigated Neurosurgical…score 15.0 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K030827Navitrack System: Total Hip Replacement CT-Free Cup, Model 900.204
Summary page 1
…tion Name: Stereotaxic Justrument (84 HAW); 21 CFR § 882.4560 Predicate Device: Navitrack System TM- Total Hip Replacement CT-Free Cup, fromn Orthosoft bec, 5 10(k) #K030827 Device Description: Identically as in the predicate, the Navitrack TM System - Total Hip Replacement CT-Free device consists of…
Orthosoft, Inc.20031

Also cleared against K030827: 1 other device →

What descends from it? (41)

See all 41

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K130387Orthoalign Plus SystemOrthalign, Inc.201331
K140331Orthalign Plus SystemOrthalign, Inc.201429
K151364Intellijoint HIP (tm) SystemIntellijoint Surgical, Inc.20158
K162364Intellijoint HIP Generation 2A SystemIntellijoint Surgical, Inc.20177

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Apr 27, 2006Not classifiedZ-2444-2008Device DesignThe three-point array 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 4 years and passes through 1 company; a new generation was cleared every 1.1 years on median.
  • 1 of the 4 ancestors has a recall of any class.
  • Of its descendants, K130387 (Orthalign, Inc., 2013) has gone furthest, with 31 descendants of its own.
  • 1 other device also cites its predicate K030827.

How does its category compare?

All HAW devices

HAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HAW

9in 2025

2007: 152008: 122009: 82010: 62011: 42012: 82013: 32014: 52015: 102016: 92017: 72018: 62019: 102020: 52021: 92022: 72023: 142024: 72025: 92026 (partial year): 5
2007high 15 (2007) · low 3 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HAW

163in 2025

2007: 107 days median2008: 112 days median2009: 221 days median2010: 138 days median2011: 66 days median2012: 178 days median2013: 172 days median2014: 238 days median2015: 232 days median2016: 175 days median2017: 226 days median2018: 112 days median2019: 147 days median2020: 88 days median2021: 168 days median2022: 128 days median2023: 142 days median2024: 107 days median2025: 163 days median2026 (partial year): 162 days median
2007high 238 (2014) · low 66 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HAW

2in 2025

2007: 22008: 102009: 62010: 282011: 52012: 42013: 6, 1 Class I2014: 52015: 32016: 52017: 22018: 2, 2 Class I2019: 4, 1 Class I2020: 12021: 4, 2 Class I2022: 12023: 4, 1 Class I2024: 2, 2 Class I2025: 22026 (partial year): 6
2007high 28 (2010) · low 1 (2020)2026

Class I (9 since 2007) Class II/III not classified

Adverse event reports per year · HAW

3,425in 2025

2007: 492008: 532009: 962010: 2992011: 1,7252012: 9862013: 1,2902014: 1,6062015: 1,7672016: 1,8282017: 3,5052018: 4,4392019: 6,0622020: 3,4802021: 2,8272022: 1,9292023: 2,5102024: 3,7552025: 3,425
2007high 6,062 (2019) · low 49 (2007)2025

MAUDE reports naming product code HAW, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200715107249
2008121121053
20098221696
2010613828299
201146651,725
201281784986
201331726 (1)1,290
2014523851,606
20151023231,767
2016917551,828
2017722623,505
201861122 (2)4,439
2019101474 (1)6,062
202058813,480
202191684 (2)2,827
2022712811,929
2023141424 (1)2,510
202471072 (2)3,755
2025916323,425
202651626—

What is it indicated for?

The Navitrack TM System - S&N Image Free Hip 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.

Also cleared against K030827

1 other device cites the same predicate.

  • K032917Navitrack System - Total Hip Replacement CT-FreeOrthosoft, Inc. · 2003

More from Orthosoft, Inc.

14 FDA decisions under this applicant name. See the company

  • K131409Cas Psi Knee SystemOrthosoft, Inc. · 20131 recall
  • K100599Cas Fixation Pin 3.2 Dia X 180 MM STR, Cas Fixaton Pin 3.2 Dia X 80 MM STR, Cas Fixaton Pin 3.2 Dia X 150 MMOrthosoft, Inc. · 2010
  • K071929Navitrack System- Partial Hip Resurfacing UniversalOrthosoft, Inc. · 20073 recalls
  • K071714Navitrack System - OS Unicondylar Knee Universal, Model# Pro-06003Orthosoft, Inc. · 20072 recalls
  • K060336Navitrack System-OS Knee Universal, Model Pro-05002Orthosoft, Inc. · 20063 recalls

Recent decisions in HAW

The HAW category page

  • K262214Disposable Reflective Marker Spheres (AM-BK115S, AM-BL130S)Guangzhou Aimooe Technology Co., Ltd. · 2026
  • K253856Geniant Cranial (Navigated Neurosurgical Positioning Robot)Koh Young Technology, Inc. · 2026
  • K261932Leksell® Vantage Stereotactic SystemElekta Solutions AB · 2026
  • K253663Zeta Navigation SystemZeta Surgical, Inc. · 2026
  • K253379Stealth AXiS Cranial clinical applicationMedtronic Navigation, Inc. · 2026

https://510kreport.com/device/K041369 · printed Nov 4, 2026

Cite this page

510(k) Report. “K041369: Navitrack System - S&N Image Free Hip, Model Pro-03017.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041369

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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