510(k) Report

510(k) · Cleared

Cleared

Stryker Navigation System - CT-Based Hip Module, Model 6007-621-000

K050615510(k) SpecialCleared Apr 21, 200543-day reviewClass II21 CFR 882.4560

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

Stryker Instruments · HAW Neurological Stereotaxic Instrument

Cleared on Apr 21, 2005 as substantially equivalent to K022365 (Stryker Instruments, 2003) and 2 other predicates after a 43-day review. Its family tree reaches back 1 generation to 2000. 29 later devices descend from it.

Decided
Apr 21, 2005
Review
43 days
Class
Class II
Product code
HAW
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K993239 (2000). 3 ancestors in all. 29 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 1 other ancestor2001: 1 other ancestor2017: 4 descendants cleared2010: 1 descendant cleared2021: 2 descendants cleared2012: 1 descendant cleared2013: 1 descendant cleared2020: 6 descendants cleared2014: 1 descendant cleared2024: 3 descendants cleared2026: 4 descendants cleared2019: 1 descendant cleared2022: 2 descendants cleared2025: 3 descendants clearedK993239 · Stryker Navigation System - Neuro Module, Model 6000-XXX-XXX · Stryker Corp. · 2000 · recalled200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 3 descendants2 generations forward: 4 descendants3 generations forward: 6 descendants4 generations forward: 4 descendants5 generations forward: 5 descendants6 generations forward: 3 descendants7 generations forward: 3 descendants8 generations forward: 1 descendant K993239 · Stryker Navigation System - Neuro Module, Model 6000-XXX-XXX · Stryker Corp. · 2000 · recalled0+5
  1. Root · 1 generation backK993239 Stryker Navigation System - Neuro Module, Model 6000-XXX-XXXStryker Corp. · 2000 · Recalled
  2. This deviceK050615 Stryker Navigation System - CT-Based Hip Module, Model 6007-621-000Stryker Instruments · 2005
  3. Descendant · cites it directly · 15 of its ownK162962 OrthAlign Plus SystemOrthalign, Inc. · 2017
  4. Descendant · 2 generations on · 12 of its ownK171780 OrthAlign Plus SystemOrthalign, Inc. · 2017
  5. Descendant · cites it directly · 11 of its ownK093425 Mako Surgical Corp Robotic Arm Interactive Orthopedic System-ThaMako Surgical Corp. · 2010 · Recalled
  6. Descendant · 2 generations on · 9 of its ownK121064 Makoplasty Total Hip Application, Rio Standard SystemMako Surgical Corporation · 2012 · Recalled
  7. Descendant · 3 generations on · 8 of its ownK172462 OrthAlign Plus SystemOrthalign, Inc. · 2017

Showing 5 of 29 descendants. See all descendants

Descendants cleared per year

2010: 12012: 12013: 12014: 12017: 42019: 12020: 62021: 22022: 22024: 32025: 32026: 4
2010high 6 (2020) · low 0 (2011)2026

Most influential descendants

Showing 5 of 29 · See all
  • K162962OrthAlign Plus SystemOrthalign, Inc. · 2017 · cites it directly15descendants
  • K171780OrthAlign Plus SystemOrthalign, Inc. · 2017 · 2 generations on12descendants
  • K093425Mako Surgical Corp Robotic Arm Interactive Orthopedic System-ThaMako Surgical Corp. · 2010 · cites it directly11descendants
  • K121064Makoplasty Total Hip Application, Rio Standard SystemMako Surgical Corporation · 2012 · 2 generations on9descendants
  • K172462OrthAlign Plus SystemOrthalign, Inc. · 2017 · 3 generations on8descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K993239Stryker Navigation System - Neuro Module, Model 6000-XXX-XXXStryker Corp.20006
0 (this device)K050615Stryker Navigation System - CT-Based Hip Module, Model 6007-621-000Stryker Instruments2005—
+1K162962OrthAlign Plus SystemOrthalign, Inc.2017—
+2K171780OrthAlign Plus SystemOrthalign, Inc.2017—
+1K093425Mako Surgical Corp Robotic Arm Interactive Orthopedic System-ThaMako Surgical Corp.20102
+2K121064Makoplasty Total Hip Application, Rio Standard SystemMako Surgical Corporation201212
+3K172462OrthAlign Plus SystemOrthalign, Inc.2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110
200310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201210
201310
201410
201740
201910
202060
202120
202220
202430
202530
202640
FIG. 1 — Lineage of K050615, 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? (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
*K022365Stryker Navigation System - Hip Module
Summary page 1
…- CT Based Hip Module Common Name: Navigation System Classification Name: Stereotactic Instruments Equivalent to: K022365 Stryker Navigation - Hip Module K993239 Stryker Navigation - Neuro Module…
Stryker Instruments200310
*K993239Stryker Navigation System - Neuro Module, Model 6000-XXX-XXX
Summary page 1
…Classification Name: Stereotactic Instruments Equivalent to: K022365 Stryker Navigation - Hip Module K993239 Stryker Navigation - Neuro Module KOI1 0602 VectorVision Hip System Device Description:…
Stryker Corp.20006
*K010602Vectorvision Hip
Our reading of the summary gave K011602, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “VectorVision Hip System”.
Brainlab AG2001—

Also cleared against K022365: 6 other devices →

What descends from it? (29)

See all 29

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

NumberDeviceApplicantDecidedDescendants
K162962OrthAlign Plus SystemOrthalign, Inc.201715
K093425Mako Surgical Corp Robotic Arm Interactive Orthopedic System-ThaMako Surgical Corp.201011
K203751OMNIVision systemCorin USA20210

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • 2 of the 3 ancestors have a recall of any class.
  • Of its descendants, K162962 (Orthalign, Inc., 2017) has gone furthest, with 15 descendants of its own.
  • 6 other devices also cite its predicate K022365.

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 system should be operated only by trained personnel such as orthopedic surgeons and clinic staff.

The Stryker Navigation System - Hip Module supports, but is not limited to the following surgical procedures

* Any form of Total Hip Athroplasty (THA), e.g. open or minimal-invasive

- Precisely position instruments, implants and bony tissue during orthopedic surgery, such as operations performed with Hip and bones in the upper extremities

• Revisions

Indications for use as stated in the FDA summary.

Also cleared against K022365

6 other devices cite the same predicate.

  • K162937Stryker OrthoMap Versatile Hip SystemStryker Corporation · 2017
  • K093425Mako Surgical Corp Robotic Arm Interactive Orthopedic System-ThaMako Surgical Corp. · 20102 recalls
  • K080450Stryker Power Tool Navigator AttachmentStryker Corp. · 2008
  • K072271Stryker Navigation System Infinitus Hip Resurfacing ModuleStryker Corp. · 2007
  • K070731Pigalileo Total Hip Replacement (THR) SystemPlus Orthopedics AG · 2007
  • K053348Stryker Orthopaedics Rfid InstrumentationHowmedica Osteonics Corp. · 2006

More from Stryker Instruments

77 FDA decisions under this applicant name. See the company

  • K262386SafeAir Electrosurgical Generator with Smoke Evacuation (0795-001-000);SafeAir Generator 3-Pedal Footswitch…Stryker Instruments · 2026
  • K262244Sonopet iQ Series III Console (5700-050-000); Sonopet iQ+ Straight Handpiece (5500-260-000); Sonopet iQ+…Stryker Instruments · 2026
  • K261959Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch…Stryker Instruments · 2026
  • K261544Hydro Irrigation SystemStryker Instruments · 2026
  • K253679Hydro Irrigation SystemStryker Instruments · 2026

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/K050615 · printed Nov 3, 2026

Cite this page

510(k) Report. “K050615: Stryker Navigation System - CT-Based Hip Module, Model 6007-621-000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K050615

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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