510(k) Report

510(k) · Cleared

Recalled · Class II · 2019

Exactech GPS

K152764510(k) TraditionalCleared Jul 13, 2016293-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

Blue Ortho · HAW Neurological Stereotaxic Instrument

Cleared on Jul 13, 2016 as substantially equivalent to K100742 (Blue Ortho, 2010) after a 293-day review. Its family tree reaches back 5 generations to 2000. 19 later devices descend from it. It has been recalled once.

Decided
Jul 13, 2016
Review
293 days
Class
Class II
Product code
HAW
Recalls
1
Predicates
1

Its longest line of descent runs back 5 generations to K002053 (2000). 9 ancestors in all. 19 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 1 other ancestor2002: 1 other ancestor2001: 2 other ancestors2017: 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 · 2006K100742 · Exactech GPS · Blue Ortho · 2010200020052010201520202025
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor4 generations back: 1 other ancestor5 generations back: 2 other ancestors 1 generation forward: 2 descendants2 generations forward: 2 descendants3 generations forward: 4 descendants4 generations forward: 8 descendants5 generations forward: 3 descendants K100742 · Exactech GPS · Blue Ortho · 2010K060282 · 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. · 2000−50+5
  1. Root · 5 generations backK002053 Navitrak System-Optical Option, Model 900.004Orthosoft, Inc. · 2000
  2. 4 generations backK021760 Navitrack System-Optical TKR CT-Less, Model 900.120Orthosoft, Inc. · 2002
  3. 3 generations backK031196 Surgetics Ortho Kneelogics Navigation SystemPraxim · 2005
  4. 2 generations backK060282 Total Knee Surgetics Navigation SystemPraxim S.A · 2006
  5. 1 generation backK100742 Exactech GPSBlue Ortho · 2010
  6. This deviceK152764 Exactech GPSBlue Ortho · 2016
  7. Descendant · cites it directly · 15 of its ownK162567 ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho · 2017 · Recalled
  8. Descendant · 2 generations on · 14 of its ownK173372 ExactechGPS Total Shoulder ApplicationBlue Ortho · 2017 · Recalled
  9. Descendant · 3 generations on · 8 of its ownK213546 ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho · 2022 · Recalled
  10. Descendant · 3 generations on · 5 of its ownK210153 NextAR RSA PlatformMedacta International S.A. · 2021 · Recalled
  11. Descendant · 4 generations on · 3 of its ownK233199 ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2024

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

2017: 22020: 12021: 12022: 22023: 42024: 32025: 42026: 2
2017high 4 (2023) · low 0 (2018)2026

Most influential descendants

Showing 5 of 19 · See all
  • K162567ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho · 2017 · cites it directly15descendants
  • K173372ExactechGPS Total Shoulder ApplicationBlue Ortho · 2017 · 2 generations on14descendants
  • K213546ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho · 2022 · 3 generations on8descendants
  • K210153NextAR RSA PlatformMedacta International S.A. · 2021 · 3 generations on5descendants
  • K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2024 · 4 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K002053Navitrak System-Optical Option, Model 900.004Orthosoft, Inc.2000—
−4K021760Navitrack System-Optical TKR CT-Less, Model 900.120Orthosoft, Inc.2002—
−3K031196Surgetics Ortho Kneelogics Navigation SystemPraxim2005—
−2K060282Total Knee Surgetics Navigation SystemPraxim S.A2006—
−1K100742Exactech GPSBlue Ortho2010—
0 (this device)K152764Exactech GPSBlue Ortho2016—
+1K162567ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho20171
+2K173372ExactechGPS Total Shoulder ApplicationBlue Ortho20171
+3K213546ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho20221
+3K210153NextAR RSA PlatformMedacta International S.A.20211
+4K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200120
200210
200310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201720
202010
202110
202220
202340
202430
202540
202620
FIG. 1 — Lineage of K152764, 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
*K100742Exactech GPS
Summary page 4
…mmon Name Stereotaxic Instruments Classification Stereotaxic Instrument (21 CFR 882.4560, Product Code OLO Class II) Name Information on 510(k) Number: K100742 devices to which Trade or Property Model Name: Exactech GPS substantial Manufacturer: BLUE ORTHO equivalence is claimed:…
Blue Ortho2010—

What descends from it? (19)

See all 19

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

NumberDeviceApplicantDecidedDescendants
K162567ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho201715
K193618ExactechGPS SystemBlue Ortho20202

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

Recalls of this device

DateClassRecallRoot causeReason
Sep 22, 2019Class IIZ-1149-2020Software designThe navigated values displayed when using the LPI instrumentation are incorrect due to software inconsistencies (wrong data loaded).

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
  • 1 of the 9 ancestors has a recall of any class.
  • Of its descendants, K162567 (Blue Ortho, 2017) has gone furthest, with 15 descendants of its own.

How does its category compare?

All HAW devices

HAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 EXACTECH GPS 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 primary and revision Total Knee Arthroplasty.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

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 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/K152764 · printed Nov 6, 2026

Cite this page

510(k) Report. “K152764: Exactech GPS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152764

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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