510(k) · Cleared
Recalled · Class II · 2020ExactechGPS System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Blue Ortho · OLO Orthopedic Stereotaxic Instrument
Cleared on Sep 2, 2020 as substantially equivalent to K152764 (Blue Ortho, 2016) after a 251-day review. Its family tree reaches back 6 generations to 2000. 2 later devices descend from it. It has been recalled once.
- Decided
- Sep 2, 2020
- Review
- 251 days
- Class
- Class II
- Product code
- OLO
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 6 generations to K002053 (2000). 10 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK002053 Navitrak System-Optical Option, Model 900.004Orthosoft, Inc. · 2000
- 5 generations backK021760 Navitrack System-Optical TKR CT-Less, Model 900.120Orthosoft, Inc. · 2002
- 4 generations backK031196 Surgetics Ortho Kneelogics Navigation SystemPraxim · 2005
- 3 generations backK060282 Total Knee Surgetics Navigation SystemPraxim S.A · 2006
- 2 generations backK100742 Exactech GPSBlue Ortho · 2010
- 1 generation backK152764 Exactech GPSBlue Ortho · 2016 · Recalled
- This deviceK193618 ExactechGPS SystemBlue Ortho · 2020
- Descendant · cites it directly · 1 of its ownK213877 ExactechGPS® SystemBlue Ortho · 2022
- Descendant · 2 generations on · 0 of its ownK233299 ExactechGPS® SystemBlue Ortho · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K002053 | Navitrak System-Optical Option, Model 900.004 | Orthosoft, Inc. | 2000 | — |
| −5 | K021760 | Navitrack System-Optical TKR CT-Less, Model 900.120 | Orthosoft, Inc. | 2002 | — |
| −4 | K031196 | Surgetics Ortho Kneelogics Navigation System | Praxim | 2005 | — |
| −3 | K060282 | Total Knee Surgetics Navigation System | Praxim S.A | 2006 | — |
| −2 | K100742 | Exactech GPS | Blue Ortho | 2010 | — |
| −1 | K152764 | Exactech GPS | Blue Ortho | 2016 | 1 |
| 0 (this device) | K193618 | ExactechGPS System | Blue Ortho | 2020 | — |
| +1 | K213877 | ExactechGPS® System | Blue Ortho | 2022 | — |
| +2 | K233299 | ExactechGPS® System | Blue Ortho | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
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 K240662 Spine Guidance Software (version 5.0); Xia 3/…score 23.7 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K152764 | Exactech GPSSummary page 4…32653 Phone: 352-377-1140 IV. INFORMATION ON DEVICES TO WHICH SUBSTANTIAL EQUIVALENCE IS CLAIMED: 510(k) Number Trade or Proprietary Model Name Manufacturer #K152764 EXACTECH GPS Blue Ortho V. PROPOSED DEVICE DESCRIPTION Trade or Proprietary or Model Name(s): Exactech… | 2016 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213877 | ExactechGPS® System | 2022 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 10, 2020 | Class II | Z-0288-2021 | Other | Appropriateness of the language used in the Tracker reprocessing instruction. Reason is that some Low Temperature sterilization conditions mentioned in the IFUs are approved based on rational documents. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 4 companies; a new generation was cleared every 4.1 years on median.
- 2 of the 10 ancestors have a recall of any class.
- Of its descendants, K213877 (Blue Ortho, 2022) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K152764.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · OLO
40in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OLO
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLO
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · OLO
3,306in 2025
MAUDE reports naming product code OLO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 11 | 126 | 0 | 4 |
| 2010 | 9 | 113 | 1 | 4 |
| 2011 | 11 | 138 | 1 | 10 |
| 2012 | 7 | 129 | 1 | 60 |
| 2013 | 7 | 137 | 0 | 36 |
| 2014 | 10 | 119 | 3 | 245 |
| 2015 | 10 | 176 | 2 | 466 |
| 2016 | 14 | 120 | 3 | 750 |
| 2017 | 33 | 91 | 2 | 1,076 |
| 2018 | 24 | 97 | 1 | 1,230 |
| 2019 | 35 | 95 | 1 | 1,585 |
| 2020 | 34 | 89 | 6 | 2,746 |
| 2021 | 28 | 91 | 0 | 1,696 |
| 2022 | 40 | 89 | 5 | 1,568 |
| 2023 | 45 | 90 | 7 (1) | 1,493 |
| 2024 | 44 | 90 | 4 | 2,353 |
| 2025 | 40 | 119 | 1 | 3,306 |
| 2026 | 42 | 109 | 6 | — |
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.
TKA Pro software application is specifically indicated for 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.
https://510kreport.com/device/K193618 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193618: ExactechGPS System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193618
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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