510(k) · Cleared
ClearedReal Intelligence™ Cori™ XT (Cori XT)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Blue Belt Technologies, Inc. · OLO Orthopedic Stereotaxic Instrument
Cleared on Dec 5, 2025 as substantially equivalent to K240139 (Blue Belt Technologies, Inc., 2024) and 1 other predicate after an 88-day review. Its family tree reaches back 24 generations to 1991.
- Decided
- Dec 5, 2025
- Review
- 88 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 24 generations to K905070 (1991). 165 ancestors in all, the oldest K800494 (1980). No later device cites it as a predicate yet.
- Root · 24 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 20 generations between
- 3 generations backK221224 Real Intelligence CoriBlue Belt Technologies, Inc. · 2022
- 2 generations backK231963 Real Intelligence™ Cori™Blue Belt Technologies, Inc. · 2023 · Recalled
- 1 generation backK240139 Real Intelligence™ CORI™Blue Belt Technologies, Inc. · 2024 · Recalled
- This deviceK252841 Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc. · 2025
Show all 24 generations
- Root · 24 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 23 generations backK961168 ViewpointPhilips Medical Systems (Cleveland), Inc. · 1996
- 22 generations backK963221 Optical Digitizer Option for View PointPhilips Medical Systems (Cleveland), Inc. · 1997
- 21 generations backK970604 Viewpoint - 3.0 SoftwarePhilips Medical Systems (Cleveland), Inc. · 1997
- 20 generations backK984298 Z Kat Flurotactic Guidance System MkiZ-Kat, Inc. · 1999
- 19 generations backK013025 Modification to Flourolab PlusZ-Kat, Inc. · 2001
- 18 generations backK031337 Acumen Surgical Navigation SystemBiomet, Inc. · 2003
- 17 generations backK072806 Mako Surgical Tactile Guidance System (TGS)Mako Surgical Corp. · 2008 · Recalled
- 16 generations backK081867 Mako Surgical Tactile Guidance System Version 2.0Mako Surgical Corp. · 2008 · Recalled
- 15 generations backK121936 NaviopfsBlue Belt Technologies, Inc. · 2012 · Recalled
- 14 generations backK140596 NAVIOBlue Belt Technologies, Inc. · 2014
- 13 generations backK143668 NavioBlue Belt Technologies, Inc. · 2015
- 12 generations backK152574 NavioBlue Belt Technologies, Inc. · 2015
- 11 generations backK160537 NavioBlue Belt Technologies, Inc. · 2016
- 10 generations backK170360 NAVIOBlue Belt Technologies, Inc. · 2017
- 9 generations backK180271 NAVIO™ Surgical System (NAVIO system)Blue Belt Technologies, Inc. · 2018
- 8 generations backK191223 NAVIOBlue Belt Technologies, Inc. · 2019
- 7 generations backK193120 Real Intelligence CoriBlue Belt Technologies, Inc. · 2020
- 6 generations backK201022 Real Intelligence Cori (Cori)Blue Belt Technologies, Inc. · 2020
- 5 generations backK212537 Real Intelligence Cori (Cori)Blue Belt Technologies, Inc. · 2021
- 4 generations backK220255 Real Intelligence CoriBlue Belt Technologies, Inc. · 2022
- 3 generations backK221224 Real Intelligence CoriBlue Belt Technologies, Inc. · 2022
- 2 generations backK231963 Real Intelligence™ Cori™Blue Belt Technologies, Inc. · 2023 · Recalled
- 1 generation backK240139 Real Intelligence™ CORI™Blue Belt Technologies, Inc. · 2024 · Recalled
- This deviceK252841 Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −24 | K905070 | Vistar | Philips Medical Systems (Cleveland), Inc. | 1991 | — |
| −23 | K961168 | Viewpoint | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| −22 | K963221 | Optical Digitizer Option for View Point | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −21 | K970604 | Viewpoint - 3.0 Software | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −20 | K984298 | Z Kat Flurotactic Guidance System Mki | Z-Kat, Inc. | 1999 | — |
| −19 | K013025 | Modification to Flourolab Plus | Z-Kat, Inc. | 2001 | — |
| −18 | K031337 | Acumen Surgical Navigation System | Biomet, Inc. | 2003 | — |
| −17 | K072806 | Mako Surgical Tactile Guidance System (TGS) | Mako Surgical Corp. | 2008 | 1 |
| −16 | K081867 | Mako Surgical Tactile Guidance System Version 2.0 | Mako Surgical Corp. | 2008 | 2 |
| −15 | K121936 | Naviopfs | Blue Belt Technologies, Inc. | 2012 | 2 |
| −14 | K140596 | NAVIO | Blue Belt Technologies, Inc. | 2014 | — |
| −13 | K143668 | Navio | Blue Belt Technologies, Inc. | 2015 | — |
| −12 | K152574 | Navio | Blue Belt Technologies, Inc. | 2015 | — |
| −11 | K160537 | Navio | Blue Belt Technologies, Inc. | 2016 | — |
| −10 | K170360 | NAVIO | Blue Belt Technologies, Inc. | 2017 | — |
| −9 | K180271 | NAVIO™ Surgical System (NAVIO system) | Blue Belt Technologies, Inc. | 2018 | — |
| −8 | K191223 | NAVIO | Blue Belt Technologies, Inc. | 2019 | — |
| −7 | K193120 | Real Intelligence Cori | Blue Belt Technologies, Inc. | 2020 | — |
| −6 | K201022 | Real Intelligence Cori (Cori) | Blue Belt Technologies, Inc. | 2020 | — |
| −5 | K212537 | Real Intelligence Cori (Cori) | Blue Belt Technologies, Inc. | 2021 | — |
| −4 | K220255 | Real Intelligence Cori | Blue Belt Technologies, Inc. | 2022 | — |
| −3 | K221224 | Real Intelligence Cori | Blue Belt Technologies, Inc. | 2022 | — |
| −2 | K231963 | Real Intelligence™ Cori™ | Blue Belt Technologies, Inc. | 2023 | 2 |
| −1 | K240139 | Real Intelligence™ CORI™ | Blue Belt Technologies, Inc. | 2024 | 1 |
| 0 (this device) | 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 | 9 | 0 |
| 2002 | 8 | 0 |
| 2003 | 7 | 0 |
| 2004 | 10 | 0 |
| 2005 | 10 | 0 |
| 2006 | 11 | 0 |
| 2007 | 5 | 0 |
| 2008 | 4 | 0 |
| 2009 | 3 | 0 |
| 2010 | 5 | 0 |
| 2011 | 5 | 0 |
| 2012 | 3 | 0 |
| 2013 | 7 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 4 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K240139 | Real Intelligence™ CORI™Summary page 5…Trade/Proprietary Name REAL INTELLIGENCE™ CORI™ XT (CORI XT) Predicate Devices Primary - REAL INTELLIGENCE™ CORI™ (K240139) Additional - ExactechGPS Total Shoulder… | 2024 |
| * | K213546 | ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareSummary page 5…Additional - ExactechGPS Total Shoulder Application, Equinoxe Planning Software (K213546) Reason for Submission The purpose of this submission is to seek clearance… | 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 34 years and passes through 5 companies; a new generation was cleared every 11 months on median.
- 36 of the 165 ancestors have a recall of any class.
- 2 other devices also cite its predicate K240139.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
REAL INTELLIGENCE ™ CORI ™ XT is indicated for use in surgical procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be determined. These procedures include:
• unicondylar knee replacement (UKR),
• total knee arthroplasty (TKA),
• revision knee arthroplasty,
• anatomic total shoulder arthroplasty (aTSA), and
• reverse total shoulder arthroplasty (rTSA).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252841 · printed Nov 4, 2026
Cite this page
510(k) Report. “K252841: Real Intelligence™ Cori™ XT (Cori XT).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K252841
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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