# K243447: Rapid Surgical Plan (RSP-SW-001)

- Pathway: 510(k) (Traditional)
- Applicant: Navbit Pty, Ltd.
- Decided: Dec 5, 2024 after 28 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: 12 generations back to K896095 (1990). 31 ancestors in all.
No later device cites it as a predicate yet.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212040: RI.Hip Modeler, Blue Belt Technologies, Inc. (2022) Summary page 5.

## Indications for use
Navbit Rapid Surgical Plan is intended for pre-operative planning for primary total hip arthroplasty. Rapid Surgical Plan is intended to be used as a tool to assist the surgeon in the selection and positioning of components in primary total hip arthroplasty. Rapid Surgical Plan is indicated for individuals undergoing primary hip surgery.

Source page: https://510kreport.com/device/K243447
Methodology: https://510kreport.com/methodology