510(k) Report

510(k) · Cleared

Recalled · Class II · 2009

Navitrack System- Partial Hip Resurfacing Universal

K071929510(k) TraditionalCleared Sep 19, 200768-day reviewClass II21 CFR 882.4560Recalls 3

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 Sep 19, 2007 as substantially equivalent to K063028 (Brainlab AG, 2006) and 2 other predicates after a 68-day review. Its family tree reaches back 4 generations to 2000. 2 later devices descend from it. It has been recalled 3 times.

Decided
Sep 19, 2007
Review
68 days
Class
Class II
Product code
HAW
Recalls
3
Predicates
3

Its longest line of descent runs back 4 generations to K002053 (2000). 14 ancestors in all. 2 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2006: 2 other ancestors2005: 2 other ancestors2004: 1 other ancestor2002: 2 other ancestors2001: 3 other ancestors2010: 1 descendant cleared2013: 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 · recalledK032917 · Navitrack System - Total Hip Replacement CT-Free · Orthosoft, Inc. · 2003200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 4 other ancestors3 generations back: 3 other ancestors4 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 1 descendant K032917 · Navitrack System - Total Hip Replacement CT-Free · Orthosoft, Inc. · 2003K030827 · 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
  1. Root · 4 generations backK002053 Navitrak System-Optical Option, Model 900.004Orthosoft, Inc. · 2000
  2. 3 generations backK022364 Navitrack System Total Hip Replacement,Model 900.200Orthosoft, Inc. · 2003
  3. 2 generations backK030827 Navitrack System: Total Hip Replacement CT-Free Cup, Model 900.204Orthosoft, Inc. · 2003 · Recalled
  4. 1 generation backK032917 Navitrack System - Total Hip Replacement CT-FreeOrthosoft, Inc. · 2003
  5. This deviceK071929 Navitrack System- Partial Hip Resurfacing UniversalOrthosoft, Inc. · 2007
  6. Descendant · cites it directly · 1 of its ownK100599 Cas Fixation Pin 3.2 Dia X 180 MM STR, Cas Fixaton Pin 3.2 Dia X 80…Orthosoft, Inc. · 2010
  7. Descendant · 2 generations on · 0 of its ownK131130 Navigation PinEvergreen Orthopedic Research Lab · 2013

Most influential descendants

Showing 2 of 2 · See all
  • K100599Cas Fixation Pin 3.2 Dia X 180 MM STR, Cas Fixaton Pin 3.2 Dia X 80 MM STR, Cas Fixaton…Orthosoft, Inc. · 2010 · cites it directly1descendant
  • K131130Navigation PinEvergreen Orthopedic Research Lab · 2013 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K002053Navitrak System-Optical Option, Model 900.004Orthosoft, Inc.2000—
−3K022364Navitrack System Total Hip Replacement,Model 900.200Orthosoft, Inc.2003—
−2K030827Navitrack System: Total Hip Replacement CT-Free Cup, Model 900.204Orthosoft, Inc.20031
−1K032917Navitrack System - Total Hip Replacement CT-FreeOrthosoft, Inc.2003—
0 (this device)K071929Navitrack System- Partial Hip Resurfacing UniversalOrthosoft, Inc.2007—
+1K100599Cas Fixation Pin 3.2 Dia X 180 MM STR, Cas Fixaton Pin 3.2 Dia X 80 MM STR…Orthosoft, Inc.2010—
+2K131130Navigation PinEvergreen Orthopedic Research Lab2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200130
200220
200410
200520
200620

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201310
FIG. 1 — Lineage of K071929, 2000–2013Source: 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? (3)

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
*K063028Vectorvision Hip SR
Summary page 1
…facing Universal Device Classification Name: Stereotaxic Instrument (84 HAW); 21 CFR § 882.4560 Predicate Devices: 1) Vectorvision® Hip SR; from Brainlab, AG; 510(k) # K063028 2) Navitrack® System - Total Hip Replacement CT-Free; from Orthosoft Inc.; 5 10(k) # K032917 3) Navitrack® System - OS Knee Un…
Brainlab AG2006—
*K032917Navitrack System - Total Hip Replacement CT-Free
Summary page 1
…Predicate Devices: 1) Vectorvision® Hip SR; from Brainlab, AG; 510(k) # K063028 2) Navitrack® System - Total Hip Replacement CT-Free; from Orthosoft Inc.; 5 10(k) # K032917 3) Navitrack® System - OS Knee Universal; from Orthosoft Inc; 510(k) # K060336 Device Description: The Navitrack® System - Parti…
Orthosoft, Inc.2003—
*K060336Navitrack System-OS Knee Universal, Model Pro-05002
Summary page 1
…28 2) Navitrack® System - Total Hip Replacement CT-Free; from Orthosoft Inc.; 5 10(k) # K032917 3) Navitrack® System - OS Knee Universal; from Orthosoft Inc; 510(k) # K060336 Device Description: The Navitrack® System - Partial Hip Resurfacing Universal system consists of software, a computer workstatio…
Orthosoft, Inc.20063

Also cleared against K063028: 3 other devices →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K100599Cas Fixation Pin 3.2 Dia X 180 MM STR, Cas Fixaton Pin 3.2 Dia X 80 MM STR, Cas Fixaton…Orthosoft, Inc.20101

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

Recalls of this device

DateClassRecallRoot causeReason
Nov 2, 2009Not classifiedZ-0558-2010Device DesignThe power cord female receptacle is not recessed sufficiently and may present a shock hazard.
Jun 9, 2009Class IIZ-2048-2017Nonconforming Material/ComponentZimmer CAS voluntarily conducted a retrospective recall on specific P7 Position Sensors (Cameras), installed on Sesamoid and Sesamoid Plasty CAS workstations due to a series of these components determined to be affected with a…
Jun 4, 2008Class IIZ-2227-2017Device DesignZimmer CAS voluntarily conducted a retrospective recall of the Sesamoid Plasty due to the risk of the top of the workstation to potentially fall over during disassembly.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 7 years and passes through 1 company; a new generation was cleared every 2.5 years on median.
  • 2 of the 14 ancestors have a recall of any class.
  • Of its descendants, K100599 (Orthosoft, Inc., 2010) has gone furthest, with 1 descendant of its own.
  • 3 other devices also cite its predicate K063028.

How does its category compare?

All HAW devices

HAW 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

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® Partial Hip Resurfacing - Universal is indicated for use as a stereotaxic instrument to assist in the positioning of partial hip resurfacing 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 femoral resurfacing 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 K063028

3 other devices cite the same predicate.

  • K122011Navigation Software Hip-Universal; Navigation Software Hip THR-AesculapBrainlab AG · 20121 recall
  • K072271Stryker Navigation System Infinitus Hip Resurfacing ModuleStryker Corp. · 2007
  • K072573Vectorvision Hip and Hip SRBrainlab AG · 2007

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
  • K071714Navitrack System - OS Unicondylar Knee Universal, Model# Pro-06003Orthosoft, Inc. · 20072 recalls
  • K060336Navitrack System-OS Knee Universal, Model Pro-05002Orthosoft, Inc. · 20063 recalls
  • K043536Navitrack System - S&N Image Free KneeOrthosoft, Inc. · 2005

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/K071929 · printed Nov 4, 2026

Cite this page

510(k) Report. “K071929: Navitrack System- Partial Hip Resurfacing Universal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071929

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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