510(k) · Cleared
ClearedCORIOGRAPH Pre-Op Planning and Modeling Services
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cleared on Nov 15, 2024 as substantially equivalent to K240113 (Smith & Nephew, Inc., 2024) and 1 other predicate after a 106-day review. Its family tree reaches back 23 generations to 1991. 1 later device descends from it.
- Decided
- Nov 15, 2024
- Review
- 106 days
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 23 generations to K905070 (1991). 126 ancestors in all, the oldest K861692 (1986). 1 later device descends from it, 1 citing it directly.
- Root · 23 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 19 generations between
- 3 generations backK220255 Real Intelligence CoriBlue Belt Technologies, Inc. · 2022
- 2 generations backK221224 Real Intelligence CoriBlue Belt Technologies, Inc. · 2022
- 1 generation backK240113 CORIOGRAPH Knee Pre-Op PlanSmith & Nephew, Inc. · 2024
- This deviceK242272 CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK250921 CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc. · 2025
Show all 23 generations
- Root · 23 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 22 generations backK961168 ViewpointPhilips Medical Systems (Cleveland), Inc. · 1996
- 21 generations backK963221 Optical Digitizer Option for View PointPhilips Medical Systems (Cleveland), Inc. · 1997
- 20 generations backK970604 Viewpoint - 3.0 SoftwarePhilips Medical Systems (Cleveland), Inc. · 1997
- 19 generations backK984298 Z Kat Flurotactic Guidance System MkiZ-Kat, Inc. · 1999
- 18 generations backK013025 Modification to Flourolab PlusZ-Kat, Inc. · 2001
- 17 generations backK031337 Acumen Surgical Navigation SystemBiomet, Inc. · 2003
- 16 generations backK072806 Mako Surgical Tactile Guidance System (TGS)Mako Surgical Corp. · 2008 · Recalled
- 15 generations backK081867 Mako Surgical Tactile Guidance System Version 2.0Mako Surgical Corp. · 2008 · Recalled
- 14 generations backK121936 NaviopfsBlue Belt Technologies, Inc. · 2012 · Recalled
- 13 generations backK140596 NAVIOBlue Belt Technologies, Inc. · 2014
- 12 generations backK143668 NavioBlue Belt Technologies, Inc. · 2015
- 11 generations backK152574 NavioBlue Belt Technologies, Inc. · 2015
- 10 generations backK160537 NavioBlue Belt Technologies, Inc. · 2016
- 9 generations backK170360 NAVIOBlue Belt Technologies, Inc. · 2017
- 8 generations backK180271 NAVIO™ Surgical System (NAVIO system)Blue Belt Technologies, Inc. · 2018
- 7 generations backK191223 NAVIOBlue Belt Technologies, Inc. · 2019
- 6 generations backK193120 Real Intelligence CoriBlue Belt Technologies, Inc. · 2020
- 5 generations backK201022 Real Intelligence Cori (Cori)Blue Belt Technologies, Inc. · 2020
- 4 generations backK212537 Real Intelligence Cori (Cori)Blue Belt Technologies, Inc. · 2021
- 3 generations backK220255 Real Intelligence CoriBlue Belt Technologies, Inc. · 2022
- 2 generations backK221224 Real Intelligence CoriBlue Belt Technologies, Inc. · 2022
- 1 generation backK240113 CORIOGRAPH Knee Pre-Op PlanSmith & Nephew, Inc. · 2024
- This deviceK242272 CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc. · 2024
Most influential descendants
Showing 1 of 1 · See all- K250921CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue 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 |
|---|---|---|---|---|---|
| −23 | K905070 | Vistar | Philips Medical Systems (Cleveland), Inc. | 1991 | — |
| −22 | K961168 | Viewpoint | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| −21 | K963221 | Optical Digitizer Option for View Point | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −20 | K970604 | Viewpoint - 3.0 Software | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −19 | K984298 | Z Kat Flurotactic Guidance System Mki | Z-Kat, Inc. | 1999 | — |
| −18 | K013025 | Modification to Flourolab Plus | Z-Kat, Inc. | 2001 | — |
| −17 | K031337 | Acumen Surgical Navigation System | Biomet, Inc. | 2003 | — |
| −16 | K072806 | Mako Surgical Tactile Guidance System (TGS) | Mako Surgical Corp. | 2008 | 1 |
| −15 | K081867 | Mako Surgical Tactile Guidance System Version 2.0 | Mako Surgical Corp. | 2008 | 2 |
| −14 | K121936 | Naviopfs | Blue Belt Technologies, Inc. | 2012 | 2 |
| −13 | K140596 | NAVIO | Blue Belt Technologies, Inc. | 2014 | — |
| −12 | K143668 | Navio | Blue Belt Technologies, Inc. | 2015 | — |
| −11 | K152574 | Navio | Blue Belt Technologies, Inc. | 2015 | — |
| −10 | K160537 | Navio | Blue Belt Technologies, Inc. | 2016 | — |
| −9 | K170360 | NAVIO | Blue Belt Technologies, Inc. | 2017 | — |
| −8 | K180271 | NAVIO™ Surgical System (NAVIO system) | Blue Belt Technologies, Inc. | 2018 | — |
| −7 | K191223 | NAVIO | Blue Belt Technologies, Inc. | 2019 | — |
| −6 | K193120 | Real Intelligence Cori | Blue Belt Technologies, Inc. | 2020 | — |
| −5 | K201022 | Real Intelligence Cori (Cori) | Blue Belt Technologies, Inc. | 2020 | — |
| −4 | K212537 | Real Intelligence Cori (Cori) | Blue Belt Technologies, Inc. | 2021 | — |
| −3 | K220255 | Real Intelligence Cori | Blue Belt Technologies, Inc. | 2022 | — |
| −2 | K221224 | Real Intelligence Cori | Blue Belt Technologies, Inc. | 2022 | — |
| −1 | K240113 | CORIOGRAPH Knee Pre-Op Plan | Smith & Nephew, Inc. | 2024 | — |
| 0 (this device) | K242272 | CORIOGRAPH Pre-Op Planning and Modeling Services | Blue Belt Technologies, Inc. | 2024 | — |
| +1 | K250921 | CORIOGRAPH Pre-Op Planning and Modeling Services | Blue Belt Technologies, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 4 | 0 |
| 2001 | 9 | 0 |
| 2002 | 10 | 0 |
| 2003 | 3 | 0 |
| 2004 | 5 | 0 |
| 2005 | 6 | 0 |
| 2006 | 5 | 0 |
| 2007 | 4 | 0 |
| 2008 | 5 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 4 | 0 |
| 2014 | 4 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 5 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 this category? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K240113 | CORIOGRAPH Knee Pre-Op PlanSummary page 5…d Instrument Guides Trade/Proprietary Name CORIOGRAPH Pre-Op Planning and Modeling Services Primary Predicate Device CORIOGRAPH Knee Pre-Op Plan (K240113) Secondary Predicate RI.HIP Modeler (K212040) Device Reason for Submission This Traditional 510(k… | 2024 |
| * | K212040 | RI.Hip ModelerSummary page 5…GRAPH Pre-Op Planning and Modeling Services Primary Predicate Device CORIOGRAPH Knee Pre-Op Plan (K240113) Secondary Predicate RI.HIP Modeler (K212040) Device Reason for Submission This Traditional 510(k) submission is seeking clearance for a new… | 2022 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250921 | CORIOGRAPH Pre-Op Planning and Modeling Services | 2025 | 0 |
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 33 years and passes through 6 companies; a new generation was cleared every 11 months on median.
- 25 of the 126 ancestors have a recall of any class.
- Of its descendants, K250921 (Blue Belt Technologies, Inc., 2025) has gone furthest, with 0 descendants of its own.
What is it indicated for?
Intended Use
CORIOGRAPH Pre-Op Planning and Modeling Services are intended to provide preoperative planning for surgical procedures based on patient imaging, provided that anatomic landmarks necessary for generating the plan are identifiable on patient imaging scans.
Indications for Use
The CORIOGRAPH Pre-op Planning and Modeling Services are indicated for use for the following procedures:
• Unicondylar Knee Replacement (UKR)
• Total Knee Arthroplasty (TKA)
• Primary Total Hip Arthroplasty (THA)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242272 · printed Nov 4, 2026
Cite this page
510(k) Report. “K242272: CORIOGRAPH Pre-Op Planning and Modeling Services.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K242272
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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