# K260206: SkeletonPlanner

- Pathway: 510(k) (Traditional)
- Applicant: UPlanner B.V. - Presurgeo
- Decided: Jul 15, 2026 after 173 days
- Product code: QIH (Automated Radiological Image Processing Software)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K924630 (1993). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213684: SurgiCase Viewer, Materialise NV (2022) Summary page 6.

## Indications for use
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.

Source page: https://510kreport.com/device/K260206
Methodology: https://510kreport.com/methodology