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
Blue Belt Technologies, Inc. · PBF Orthopaedic Surgical Planning And Instrument Guides
Cleared on Jun 25, 2025 as substantially equivalent to K242272 (Blue Belt Technologies, Inc., 2024) and 1 other predicate after a 90-day review. Its family tree reaches back 24 generations to 1991.
- Decided
- Jun 25, 2025
- Review
- 90 days
- Class
- Class II
- Product code
- PBF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 24 generations to K905070 (1991). 135 ancestors in all, the oldest K861692 (1986). 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 backK240113 CORIOGRAPH Knee Pre-Op PlanSmith & Nephew, Inc. · 2024
- 1 generation backK242272 CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc. · 2024
- This deviceK250921 CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue 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 backK240113 CORIOGRAPH Knee Pre-Op PlanSmith & Nephew, Inc. · 2024
- 1 generation backK242272 CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc. · 2024
- This deviceK250921 CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue 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 | K240113 | CORIOGRAPH Knee Pre-Op Plan | Smith & Nephew, Inc. | 2024 | — |
| −1 | K242272 | CORIOGRAPH Pre-Op Planning and Modeling Services | Blue Belt Technologies, Inc. | 2024 | — |
| 0 (this device) | 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 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 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 PBF? 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 PBF device
- #1 K241811 MedCAD® AccuStride™ Systemscore 17.1 · 8 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 |
|---|---|---|---|
| * | K242272 | CORIOGRAPH Pre-Op Planning and Modeling ServicesSummary page 5…Trade/Proprietary Name CORIOGRAPH Pre-Op Planning and Modeling Services Primary Predicate Device CORIOGRAPH Pre-Op Planning and Modeling Services (K242272) Secondary Predicate Materialise SurgiCase Shoulder Planner (K242813) Device Reason for Submission T… | 2024 |
| * | K242813 | Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder…Summary page 5…Primary Predicate Device CORIOGRAPH Pre-Op Planning and Modeling Services (K242272) Secondary Predicate Materialise SurgiCase Shoulder Planner (K242813) Device Reason for Submission The purpose of this Traditional 510(k) submission is to seek… | 2024 |
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 6 companies; a new generation was cleared every 11 months on median.
- 25 of the 135 ancestors have a recall of any class.
How does its category compare?
All PBF devicesPBF Orthopaedic Surgical Planning And Instrument Guides: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · PBF
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PBF
227in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PBF
No recall names PBF since 2007.
Adverse event reports per year · PBF
62in 2025
MAUDE reports naming product code PBF, 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 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 1 | — | 0 | 2 |
| 2021 | 2 | — | 0 | 12 |
| 2022 | 3 | 435 | 0 | 53 |
| 2023 | 5 | 314 | 0 | 45 |
| 2024 | 3 | 62 | 0 | 34 |
| 2025 | 8 | 227 | 0 | 62 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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.
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)
• Primary Anatomic Total Shoulder Arthroplasty (aTSA)
• Primary Reverse Total Shoulder Arthroplasty (rTSA)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250921 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250921: CORIOGRAPH Pre-Op Planning and Modeling Services.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250921
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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