# K212040: RI.Hip Modeler

- Pathway: 510(k) (Traditional)
- Applicant: Blue Belt Technologies, Inc.
- Decided: Mar 11, 2022 after 254 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: 11 generations back to K896095 (1990). 30 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173390: hipEOS, Onefit Medical (2018) Summary page 4.

## Most influential descendants
- K242272: CORIOGRAPH Pre-Op Planning and Modeling Services (2024), 1 descendant of its own
- K250921: CORIOGRAPH Pre-Op Planning and Modeling Services (2025), 0 descendants of its own
- K243447: Rapid Surgical Plan (RSP-SW-001) (2024), 0 descendants of its own

## Indications for use
RI.LHIP MODELER is intended for preoperative planning for primary total hip arthroplasty. R.LHIP MODELER is intended to be used as a tool to assist the surgeon in the selection and positioning of components in primary total hip arthroplasty. RI.HIP MODELER is indicated for individuals undergoing primary hip surgery.

Source page: https://510kreport.com/device/K212040
Methodology: https://510kreport.com/methodology