510(k) · Cleared
Recalled · Class II · 2023ExactechGPS 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 Jan 6, 2022 as substantially equivalent to K173372 (Blue Ortho, 2017) and 1 other predicate after a 59-day review. Its family tree reaches back 13 generations to 1991. 8 later devices descend from it. It has been recalled once.
- Decided
- Jan 6, 2022
- Review
- 59 days
- Class
- Class II
- Product code
- OLO
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 13 generations to K905070 (1991). 124 ancestors in all, the oldest K800494 (1980). 8 later devices descend from it, 4 citing it directly.
- Root · 13 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 9 generations between
- 3 generations backK160555 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2016
- 2 generations backK162800 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2017
- 1 generation backK203315 BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S. · 2021
- This deviceK213546 ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho · 2022
- Descendant · cites it directly · 3 of its ownK233199 ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2024
- Descendant · 2 generations on · 1 of its ownK250108 OptiVu™ ShoulderMr Surgical Solutions, LLC · 2025
- Descendant · cites it directly · 1 of its ownK230904 Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK260582 ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS · 2026
- Descendant · cites it directly · 0 of its ownK252841 Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc. · 2025
Show all 13 generations
- Root · 13 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 12 generations backK961168 ViewpointPhilips Medical Systems (Cleveland), Inc. · 1996
- 11 generations backK963221 Optical Digitizer Option for View PointPhilips Medical Systems (Cleveland), Inc. · 1997
- 10 generations backK970604 Viewpoint - 3.0 SoftwarePhilips Medical Systems (Cleveland), Inc. · 1997
- 9 generations backK984298 Z Kat Flurotactic Guidance System MkiZ-Kat, Inc. · 1999
- 8 generations backK013025 Modification to Flourolab PlusZ-Kat, Inc. · 2001
- 7 generations backK031454 Acumen Surgical Navigation SystemBiomet, Inc. · 2004
- 6 generations backK111863 Signature Planner,Signature GuidesMaterialise NV · 2012
- 5 generations backK130126 Signature Personalized Patient Care System - Glenoid Guide SystemBiomet, Inc. · 2013
- 4 generations backK143374 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2015
- 3 generations backK160555 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2016
- 2 generations backK162800 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2017
- 1 generation backK203315 BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S. · 2021
- This deviceK213546 ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho · 2022
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2024 · cites it directly3descendants
- K250108OptiVu™ ShoulderMr Surgical Solutions, LLC · 2025 · 2 generations on1descendant
- K230904Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc. · 2023 · cites it directly1descendant
- K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS · 2026 · 2 generations on0descendants
- K252841Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K905070 | Vistar | Philips Medical Systems (Cleveland), Inc. | 1991 | — |
| −12 | K961168 | Viewpoint | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| −11 | K963221 | Optical Digitizer Option for View Point | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −10 | K970604 | Viewpoint - 3.0 Software | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −9 | K984298 | Z Kat Flurotactic Guidance System Mki | Z-Kat, Inc. | 1999 | — |
| −8 | K013025 | Modification to Flourolab Plus | Z-Kat, Inc. | 2001 | — |
| −7 | K031454 | Acumen Surgical Navigation System | Biomet, Inc. | 2004 | — |
| −6 | K111863 | Signature Planner,Signature Guides | Materialise NV | 2012 | — |
| −5 | K130126 | Signature Personalized Patient Care System - Glenoid Guide System | Biomet, Inc. | 2013 | — |
| −4 | K143374 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2015 | — |
| −3 | K160555 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2016 | — |
| −2 | K162800 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2017 | — |
| −1 | K203315 | BLUEPRINT™ Patient Specific Instrumentation | Tornier S.A.S. | 2021 | — |
| 0 (this device) | K213546 | ExactechGPS Total Shoulder Application, Equinoxe Planning Software | Blue Ortho | 2022 | — |
| +1 | K233199 | ROSA® Shoulder System | Orthosoft Inc (D/B/A Zimmer Cas) | 2024 | — |
| +2 | K250108 | OptiVu™ Shoulder | Mr Surgical Solutions, LLC | 2025 | — |
| +1 | K230904 | Arthrex Virtual Implant Positioning (VIP) System | Arthrex, Inc. | 2023 | — |
| +2 | K260582 | ROSA® Shoulder System | Orthosoft Inc. (d/b/a) Zimmer CAS | 2026 | — |
| +1 | K252841 | Real Intelligence™ Cori™ XT (Cori XT) | Blue Belt Technologies, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 2 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 3 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1996 | 5 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 7 | 0 |
| 2000 | 7 | 0 |
| 2001 | 7 | 0 |
| 2002 | 6 | 0 |
| 2003 | 6 | 0 |
| 2004 | 8 | 0 |
| 2005 | 7 | 0 |
| 2006 | 9 | 0 |
| 2007 | 3 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 4 | 0 |
| 2011 | 5 | 0 |
| 2012 | 2 | 0 |
| 2013 | 4 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K173372 | ExactechGPS Total Shoulder ApplicationSummary page 4…ICES TO WHICH SUBSTANTIAL EQUIVALENCE IS CLAIMED Primary Predicate 510(k) Number Trade or Proprietary Model Name Manufacturer #K173372 ExactechGPS® Total Shoulder Application Blue Ortho This predicate has not been subject to a design-related r… | 2017 |
| * | K203315 | BLUEPRINT™ Patient Specific InstrumentationSummary page 4…e has not been subject to a design-related recall. Additional Predicates 510(k) Number Trade or Proprietary Model Name Manufacturer #K203315 BLUEPRINT™ Patient Specific TORNIER SAS Instrumentation V. PROPOSED DEVICE… | 2021 |
What descends from it? (8)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 5, 2023 | Class II | Z-2050-2023 | Process control | The ball and spring housed within the locking mechanism of the handle can dislodge during disassembly or during impaction. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 31 years and passes through 6 companies; a new generation was cleared every 1.7 years on median.
- 25 of the 124 ancestors have a recall of any class.
- Of its descendants, K233199 (Orthosoft Inc (D/B/A Zimmer Cas), 2024) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K173372.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 orthopedic 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 Planning Application is specifically indicated for pre-operative planning of Total Shoulder Arthroplasty using…
Read the full statement (123 words)
The ExactechGPS is intended for use during preoperative planning and during orthopedic 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 Planning Application is specifically indicated for pre-operative planning of Total Shoulder Arthroplasty using the Equinoxe system. The ExactechGPS Total Shoulder Planning Application permits to visualize, measure and reconstruct anatomical structures in order to select and place the glenoid and humeral components.
The ExactechGPS Total Shoulder Navigation 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 as stated in the FDA summary.
https://510kreport.com/device/K213546 · printed Nov 4, 2026
Cite this page
510(k) Report. “K213546: ExactechGPS Total Shoulder Application, Equinoxe Planning Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K213546
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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