510(k) · Cleared
ClearedSkeletonPlanner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
UPlanner B.V. - Presurgeo · QIH Automated Radiological Image Processing Software
Cleared on Jul 15, 2026 as substantially equivalent to K213684 (Materialise NV, 2022) after a 173-day review. Its family tree reaches back 8 generations to 1993.
- Decided
- Jul 15, 2026
- Review
- 173 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K924630 (1993). 15 ancestors in all, the oldest K924810 (1993). No later device cites it as a predicate yet.
- Root · 8 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
- 7 generations backK970617 CT-Modeller SystemMaterialise NV · 1997
- 6 generations backK033849 Simplant SystemMaterialise NV · 2004
- 5 generations backK073449 SurgicaseMaterialise NV · 2008
- 4 generations backK112389 Surgicase Connect, Surgicase GuideMaterialise NV · 2012
- 3 generations backK132290 Surgicase Orthopaedics System, Surgicase Connect, Surgicase GuidesMaterialise NV · 2014
- 2 generations backK170419 SurgiCase ViewerMaterialise NV · 2017
- 1 generation backK213684 SurgiCase ViewerMaterialise NV · 2022
- This deviceK260206 SkeletonPlannerUPlanner B.V. - Presurgeo · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K924630 | Surgicad (TM) View (TM) | Surgicad Corp. | 1993 | — |
| −7 | K970617 | CT-Modeller System | Materialise NV | 1997 | — |
| −6 | K033849 | Simplant System | Materialise NV | 2004 | — |
| −5 | K073449 | Surgicase | Materialise NV | 2008 | — |
| −4 | K112389 | Surgicase Connect, Surgicase Guide | Materialise NV | 2012 | — |
| −3 | K132290 | Surgicase Orthopaedics System, Surgicase Connect, Surgicase Guides | Materialise NV | 2014 | — |
| −2 | K170419 | SurgiCase Viewer | Materialise NV | 2017 | — |
| −1 | K213684 | SurgiCase Viewer | Materialise NV | 2022 | — |
| 0 (this device) | K260206 | SkeletonPlanner | UPlanner B.V. - Presurgeo | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2019 | 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 QIH? 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 QIH device
- #1 K213998 cvi42 Auto Imaging Software Applicationscore 23.5 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K213684 | SurgiCase ViewerSummary page 6…ollowing legally marketed predicate device: Trade Name SurgiCase Viewer Manufacturer Materialise NV 510(k) Number K213684 Regulation Number 21 CFR 892.2050 Regulation Name Medical image management and processing system Pr… | 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 33 years and passes through 3 companies; a new generation was cleared every 4.1 years on median.
- 1 of the 15 ancestors has a recall of any class.
How does its category compare?
All QIH devicesQIH Automated Radiological Image Processing Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · QIH
94in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QIH
150in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QIH
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QIH
4in 2025
MAUDE reports naming product code QIH, 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 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 11 | 145 | 0 | 0 |
| 2021 | 19 | 125 | 0 | 0 |
| 2022 | 25 | 134 | 0 | 0 |
| 2023 | 45 | 151 | 0 | 0 |
| 2024 | 64 | 141 | 0 | 2 |
| 2025 | 94 | 150 | 0 | 4 |
| 2026 | 78 | 130 | 1 | — |
What is it indicated for?
SkeletonPlanner is intended to assist radiologists and orthopedic surgeons in the analysis of lower extremity alignment and/or preoperative planning of skeletal surgery procedures. It supports assessment of bone deformities in the femur and tibia and plan corrections for deformities amenable to single femoral or tibial osteotomies for skeletally mature patients 18 years of age and older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260206 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260206: SkeletonPlanner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260206
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026