510(k) Report

510(k) · Cleared

Cleared

Exactech GPS

K100742510(k) TraditionalCleared Oct 21, 2010219-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

Blue Ortho · OLO Orthopedic Stereotaxic Instrument

Cleared on Oct 21, 2010 as substantially equivalent to K022579 (Stryker Leibinger, 2003) and 1 other predicate after a 219-day review. Its family tree reaches back 4 generations to 2000. 20 later devices descend from it.

Decided
Oct 21, 2010
Review
219 days
Class
Class II
Product code
OLO
Recalls
None
Predicates
2

Its longest line of descent runs back 4 generations to K002053 (2000). 8 ancestors in all. 20 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 1 other ancestor2002: 1 other ancestor2001: 2 other ancestors2016: 1 descendant cleared2017: 2 descendants cleared2020: 1 descendant cleared2022: 2 descendants cleared2023: 4 descendants cleared2021: 1 descendant cleared2024: 3 descendants cleared2025: 4 descendants cleared2026: 2 descendants clearedK002053 · Navitrak System-Optical Option, Model 900.004 · Orthosoft, Inc. · 2000K021760 · Navitrack System-Optical TKR CT-Less, Model 900.120 · Orthosoft, Inc. · 2002K031196 · Surgetics Ortho Kneelogics Navigation System · Praxim · 2005K060282 · Total Knee Surgetics Navigation System · Praxim S.A · 2006200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor3 generations back: 1 other ancestor4 generations back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 2 descendants4 generations forward: 4 descendants5 generations forward: 8 descendants6 generations forward: 3 descendants K060282 · Total Knee Surgetics Navigation System · Praxim S.A · 2006K031196 · Surgetics Ortho Kneelogics Navigation System · Praxim · 2005K021760 · Navitrack System-Optical TKR CT-Less, Model 900.120 · Orthosoft, Inc. · 2002K002053 · Navitrak System-Optical Option, Model 900.004 · Orthosoft, Inc. · 20000+5
  1. Root · 4 generations backK002053 Navitrak System-Optical Option, Model 900.004Orthosoft, Inc. · 2000
  2. 3 generations backK021760 Navitrack System-Optical TKR CT-Less, Model 900.120Orthosoft, Inc. · 2002
  3. 2 generations backK031196 Surgetics Ortho Kneelogics Navigation SystemPraxim · 2005
  4. 1 generation backK060282 Total Knee Surgetics Navigation SystemPraxim S.A · 2006
  5. This deviceK100742 Exactech GPSBlue Ortho · 2010
  6. Descendant · cites it directly · 19 of its ownK152764 Exactech GPSBlue Ortho · 2016 · Recalled
  7. Descendant · 2 generations on · 15 of its ownK162567 ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho · 2017 · Recalled
  8. Descendant · 3 generations on · 14 of its ownK173372 ExactechGPS Total Shoulder ApplicationBlue Ortho · 2017 · Recalled
  9. Descendant · 4 generations on · 8 of its ownK213546 ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho · 2022 · Recalled
  10. Descendant · 4 generations on · 5 of its ownK210153 NextAR RSA PlatformMedacta International S.A. · 2021 · Recalled

Showing 5 of 20 descendants. See all descendants

Descendants cleared per year

2016: 12017: 22020: 12021: 12022: 22023: 42024: 32025: 42026: 2
2016high 4 (2023) · low 0 (2018)2026

Most influential descendants

Showing 5 of 20 · See all
  • K152764Exactech GPSBlue Ortho · 2016 · cites it directly19descendants
  • K162567ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho · 2017 · 2 generations on15descendants
  • K173372ExactechGPS Total Shoulder ApplicationBlue Ortho · 2017 · 3 generations on14descendants
  • K213546ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho · 2022 · 4 generations on8descendants
  • K210153NextAR RSA PlatformMedacta International S.A. · 2021 · 4 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K002053Navitrak System-Optical Option, Model 900.004Orthosoft, Inc.2000—
−3K021760Navitrack System-Optical TKR CT-Less, Model 900.120Orthosoft, Inc.2002—
−2K031196Surgetics Ortho Kneelogics Navigation SystemPraxim2005—
−1K060282Total Knee Surgetics Navigation SystemPraxim S.A2006—
0 (this device)K100742Exactech GPSBlue Ortho2010—
+1K152764Exactech GPSBlue Ortho20161
+2K162567ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho20171
+3K173372ExactechGPS Total Shoulder ApplicationBlue Ortho20171
+4K213546ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho20221
+4K210153NextAR RSA PlatformMedacta International S.A.20211

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200120
200210
200310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201610
201720
202010
202110
202220
202340
202430
202540
202620
FIG. 1 — Lineage of K100742, 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 OLO? 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 OLO device

  1. #1 K240662 Spine Guidance Software (version 5.0); Xia 3/…score 23.7 · 15 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? (2)

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
*K022579Stryker Navigation System-Knee Module
Summary page 1
…HAW Predicate Device: BLUE NAVIGATION SYSTEM is substantially equivalent to the STRYKER NAVIGATION SYSTEM -KNEE MODULE cleared under 510(k) #K022579 and the TOTAL KNEE SURGETICS NAVIGATION SYSTEM cleared under #K060282. Device Description: The BLUE NAVIGATION SYSTEM is an imag…
Stryker Leibinger20037
*K060282Total Knee Surgetics Navigation System
Summary page 1
…lly equivalent to the STRYKER NAVIGATION SYSTEM -KNEE MODULE cleared under 510(k) #K022579 and the TOTAL KNEE SURGETICS NAVIGATION SYSTEM cleared under #K060282. Device Description: The BLUE NAVIGATION SYSTEM is an image guided, or navigation, system for orthopedic surgical procedures. It…
Praxim S.A2006—

Also cleared against K022579: 2 other devices →

What descends from it? (20)

See all 20

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

NumberDeviceApplicantDecidedDescendants
K152764Exactech GPSBlue Ortho201619

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?

  • The line of descent spans 10 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
  • 1 of the 8 ancestors has a recall of any class.
  • Of its descendants, K152764 (Blue Ortho, 2016) has gone furthest, with 19 descendants of its own.
  • 2 other devices also cite its predicate K022579.

How does its category compare?

All OLO devices

OLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · OLO

40in 2025

2009: 112010: 92011: 112012: 72013: 72014: 102015: 102016: 142017: 332018: 242019: 352020: 342021: 282022: 402023: 452024: 442025: 402026 (partial year): 42
2007high 45 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OLO

119in 2025

2009: 126 days median2010: 113 days median2011: 138 days median2012: 129 days median2013: 137 days median2014: 119 days median2015: 176 days median2016: 120 days median2017: 91 days median2018: 97 days median2019: 95 days median2020: 89 days median2021: 91 days median2022: 89 days median2023: 90 days median2024: 90 days median2025: 119 days median2026 (partial year): 109 days median
2007high 176 (2015) · low 89 (2020)2026

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

Recalls per year · OLO

1in 2025

2010: 12011: 12012: 12014: 32015: 22016: 32017: 22018: 12019: 12020: 62022: 52023: 7, 1 Class I2024: 42025: 12026 (partial year): 6
2007high 7 (2023) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · OLO

3,306in 2025

2008: 12009: 42010: 42011: 102012: 602013: 362014: 2452015: 4662016: 7502017: 1,0762018: 1,2302019: 1,5852020: 2,7462021: 1,6962022: 1,5682023: 1,4932024: 2,3532025: 3,306
2007high 3,306 (2025) · low 0 (2007)2025

MAUDE reports naming product code OLO, 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
20070—00
20080—01
20091112604
2010911314
201111138110
20127129160
20137137036
2014101193245
2015101762466
2016141203750
2017339121,076
2018249711,230
2019359511,585
2020348962,746
2021289101,696
2022408951,568
202345907 (1)1,493
2024449042,353
20254011913,306
2026421096—

What is it indicated for?

The BLUE NAVIGATION SYSTEM is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures.

It is specifically indicated for Total Knee Arthroplasty.

Indications for use as stated in the FDA summary.

Also cleared against K022579

2 other devices cite the same predicate.

  • K153240Styrker OrthoMap Express Knee SystemStryker Corporate · 2016
  • K141941Spinemask Tracker, Spinemap 3D 3.0-Software,Spinemap 3D 3.0-Upgreade, Spinemap 3D 3.0-Enable, Spinemap 3D…Stryker Corporate · 2014

More from Blue Ortho

9 FDA decisions under this applicant name. See the company

  • K233299ExactechGPS® SystemBlue Ortho · 2024
  • K232521ExactechGPS® Total Ankle ApplicationBlue Ortho · 2023
  • K213877ExactechGPS® SystemBlue Ortho · 2022
  • K213546ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho · 20221 recall
  • K193618ExactechGPS SystemBlue Ortho · 20201 recall

Recent decisions in OLO

The OLO category page

  • K2604037D Surgical System (10-0001)7D Surgical ULC · 2026
  • K263234TMINI Miniature Robotic SystemTHINK Surgical, Inc. · 2026
  • K263154CarboClear® Cervical Navigated InstrumentsCarboFix Orhtopedics, Ltd. · 2026
  • K262257Spine Planning (3.0); Spine & Trauma Navigation; Alignment System SpineBrainlab SE · 2026
  • K262506Remex Spine Surgery Navigation - Universal InstrumentsRemex Medical Corp. · 2026

https://510kreport.com/device/K100742 · printed Nov 3, 2026

Cite this page

510(k) Report. “K100742: Exactech GPS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K100742

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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