510(k) · Cleared
ClearedExactechGPS® 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 Jan 26, 2024 as substantially equivalent to K213877 (Blue Ortho, 2022) after a 119-day review. Its family tree reaches back 8 generations to 2000.
- Decided
- Jan 26, 2024
- Review
- 119 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K002053 (2000). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK002053 Navitrak System-Optical Option, Model 900.004Orthosoft, Inc. · 2000
- 7 generations backK021760 Navitrack System-Optical TKR CT-Less, Model 900.120Orthosoft, Inc. · 2002
- 6 generations backK031196 Surgetics Ortho Kneelogics Navigation SystemPraxim · 2005
- 5 generations backK060282 Total Knee Surgetics Navigation SystemPraxim S.A · 2006
- 4 generations backK100742 Exactech GPSBlue Ortho · 2010
- 3 generations backK152764 Exactech GPSBlue Ortho · 2016 · Recalled
- 2 generations backK193618 ExactechGPS SystemBlue Ortho · 2020 · Recalled
- 1 generation backK213877 ExactechGPS® SystemBlue Ortho · 2022
- This deviceK233299 ExactechGPS® SystemBlue Ortho · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K002053 | Navitrak System-Optical Option, Model 900.004 | Orthosoft, Inc. | 2000 | — |
| −7 | K021760 | Navitrack System-Optical TKR CT-Less, Model 900.120 | Orthosoft, Inc. | 2002 | — |
| −6 | K031196 | Surgetics Ortho Kneelogics Navigation System | Praxim | 2005 | — |
| −5 | K060282 | Total Knee Surgetics Navigation System | Praxim S.A | 2006 | — |
| −4 | K100742 | Exactech GPS | Blue Ortho | 2010 | — |
| −3 | K152764 | Exactech GPS | Blue Ortho | 2016 | 1 |
| −2 | K193618 | ExactechGPS System | Blue Ortho | 2020 | 1 |
| −1 | K213877 | ExactechGPS® System | Blue Ortho | 2022 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K213877 | ExactechGPS® SystemSummary page 4…377-1140 IV. INFORMATION ON DEVICES TO WHICH SUBSTANTIAL EQUIVALENCE IS CLAIMED 510(k) Number Trade or Proprietary Model Name Manufacturer #K213877 ExactechGPS System Blue Ortho This predicate has not been subject to a design-related recall… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
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 24 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
- 3 of the 12 ancestors have a recall of any class.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 ExactechGPS® System 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 as stated in the FDA summary.
https://510kreport.com/device/K233299 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233299: 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/K233299
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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