510(k) · Cleared
Recalled · Class II · 2017ExactechGPS Total Shoulder Application, Equinoxe Planning Software
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 Apr 5, 2017 as substantially equivalent to K152764 (Blue Ortho, 2016) and 2 other predicates after a 203-day review. Its family tree reaches back 9 generations to 1991. 15 later devices descend from it. It has been recalled once.
- Decided
- Apr 5, 2017
- Review
- 203 days
- Class
- Class II
- Product code
- OLO
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 9 generations to K911686 (1991). 57 ancestors in all, the oldest K800494 (1980). 15 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 5 generations between
- 3 generations backK123122 Glenoid Intelligent Reusable Instrument System (Glenoid Iris)Cleveland Clinic · 2013
- 2 generations backK133367 Orthovis Preoperative PlanCustom Orthopaedic Solutions · 2013
- 1 generation backK151568 Arthrex OrthoVis Preoperative PlanCustom Orthopaedic Solutions, Inc. · 2015
- This deviceK162567 ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho · 2017
- Descendant · cites it directly · 14 of its ownK173372 ExactechGPS Total Shoulder ApplicationBlue Ortho · 2017 · Recalled
- Descendant · 2 generations on · 8 of its ownK213546 ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho · 2022 · Recalled
- Descendant · 2 generations on · 5 of its ownK210153 NextAR RSA PlatformMedacta International S.A. · 2021 · Recalled
- Descendant · 3 generations on · 3 of its ownK233199 ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2024
- Descendant · 3 generations on · 1 of its ownK250108 OptiVu™ ShoulderMr Surgical Solutions, LLC · 2025
Show all 9 generations
- Root · 9 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 8 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 7 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 6 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 5 generations backK062116 Delta Cta Reverse Shoulder System Humeral HeadsDePuy Orthopaedics, Inc. · 2006
- 4 generations backK062250 Delta Xtend Reverse Shoulder SystemDePuy Orthopaedics, Inc. · 2007 · Recalled
- 3 generations backK123122 Glenoid Intelligent Reusable Instrument System (Glenoid Iris)Cleveland Clinic · 2013
- 2 generations backK133367 Orthovis Preoperative PlanCustom Orthopaedic Solutions · 2013
- 1 generation backK151568 Arthrex OrthoVis Preoperative PlanCustom Orthopaedic Solutions, Inc. · 2015
- This deviceK162567 ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho · 2017
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K173372ExactechGPS Total Shoulder ApplicationBlue Ortho · 2017 · cites it directly14descendants
- K213546ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho · 2022 · 2 generations on8descendants
- K210153NextAR RSA PlatformMedacta International S.A. · 2021 · 2 generations on5descendants
- K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2024 · 3 generations on3descendants
- K250108OptiVu™ ShoulderMr Surgical Solutions, LLC · 2025 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −8 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −7 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −6 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −5 | K062116 | Delta Cta Reverse Shoulder System Humeral Heads | DePuy Orthopaedics, Inc. | 2006 | — |
| −4 | K062250 | Delta Xtend Reverse Shoulder System | DePuy Orthopaedics, Inc. | 2007 | 8 |
| −3 | K123122 | Glenoid Intelligent Reusable Instrument System (Glenoid Iris) | Cleveland Clinic | 2013 | — |
| −2 | K133367 | Orthovis Preoperative Plan | Custom Orthopaedic Solutions | 2013 | — |
| −1 | K151568 | Arthrex OrthoVis Preoperative Plan | Custom Orthopaedic Solutions, Inc. | 2015 | — |
| 0 (this device) | K162567 | ExactechGPS Total Shoulder Application, Equinoxe Planning Software | Blue Ortho | 2017 | — |
| +1 | K173372 | ExactechGPS Total Shoulder Application | Blue Ortho | 2017 | 1 |
| +2 | K213546 | ExactechGPS Total Shoulder Application, Equinoxe Planning Software | Blue Ortho | 2022 | 1 |
| +2 | K210153 | NextAR RSA Platform | Medacta International S.A. | 2021 | 1 |
| +3 | K233199 | ROSA® Shoulder System | Orthosoft Inc (D/B/A Zimmer Cas) | 2024 | — |
| +3 | K250108 | OptiVu™ Shoulder | Mr Surgical Solutions, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 4 | 0 |
| 2000 | 4 | 0 |
| 2001 | 6 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 3 | 0 |
| 2006 | 4 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 2 | 0 |
| 2025 | 4 | 0 |
| 2026 | 2 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K152764 | Exactech GPSSummary page 5…ance Information on Devices to which Substantial Equivalence is Claimed: Primary Predicate 510(k) Number Trade or Proprietary Model Name Manufacturer #K152764 EXACTECH GPS Blue Ortho Additional Predicates 510(k) Number Trade or Proprietary… | 2016 |
| * | K063408 | Ctlogics Navigations SystemsSummary page 5…EXACTECH GPS Blue Ortho Additional Predicates 510(k) Number Trade or Proprietary Model Name Manufacturer #K063408 CTLOGICS Navigation System Praxim #K151568 OrthoVis Preoperative Plan… | 2007 |
| * | K151568 | Arthrex OrthoVis Preoperative PlanSummary page 5…ional Predicates 510(k) Number Trade or Proprietary Model Name Manufacturer #K063408 CTLOGICS Navigation System Praxim #K151568 OrthoVis Preoperative Plan Arthrex Indications for Use: The ExactechGPS is intended for use during… | 2015 |
What descends from it? (15)
See all 151 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173372 | ExactechGPS Total Shoulder Application | 2017 | 14 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 11, 2017 | Class II | Z-0603-2018 | Nonconforming Material/Component | Vix Bit may fracture during use. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 6 companies; a new generation was cleared every 1.7 years on median.
- 12 of the 57 ancestors have a recall of any class.
- Of its descendants, K173372 (Blue Ortho, 2017) has gone furthest, with 14 descendants 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. 2017, 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 is intended for use during preoperative planning and during stereotaxic surgery to aid the surgeon in locating anatomical structures and aligning the endoprosthesis with the anatomical structures provided that the required anatomical landmarks can be identified on the patient's preoperative CT scan.
The ExactechGPS Total Shoulder Application is specifically indicated for Total Shoulder Arthroplasty using the Equinoxe system to aid the surgeon in locating anatomical structures and aligning the glenoid component with the anatomical structures.
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/K162567 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162567: ExactechGPS Total Shoulder Application, Equinoxe Planning Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162567
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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