# K262442: HipStudio Analysis

- Pathway: 510(k) (Traditional)
- Applicant: Replasia BV
- Decided: Sep 22, 2026 after 68 days
- Product code: LLZ (System, Image Processing, Radiological)
- 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: 6 generations back to K924630 (1993). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162559: Move Forward 3D Motion Simulation Service, Biomet, Inc. (2017) Summary page 5.

## Indications for use
HipStudio Simulation Service is an online image analysis service indicated for skeletally mature individuals that are suspected of suffering from symptomatic or asymptomatic hip conditions including but not limited to developmental dysplasia of the hip (DOH) and femoroacetabular impingement (FAI). It enables clinicians to obtain 3D motion simulation reports based on CT image data. The service can be used by uploading CT image data of hip joints. The image data is processed by Replasia to create 3D anatomy models. These 3D models are then used to perform 3D motion simulations of the hip joint for different treatment approaches and to calculate bone-to-bone contact points where impingement occurs. The HipStudio Simulation Service also calculates several morphological shape parameters for each of the 3D anatomy models. The software generates a report as output. Clinicians do not interact with the image analysis software directly. The image analysis software is only operated by Replasia operators who have been specifically trained for this purpose. End users of the generated HipStudio Simulation Service reports are trained medical professionals, including radiologists and orthopedic surqeons.

Source page: https://510kreport.com/device/K262442
Methodology: https://510kreport.com/methodology