# K231503: CUPTIMIZE™ Advanced

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Aug 22, 2023 after 90 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). 26 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203651: Cuptimize, Cuptimize, Inc. (2021) Summary page 4.

## Most influential descendants
- K242161: Radlink GPS Pro Imaging (2025), 0 descendants of its own

## Indications for use
CUPTIMIZE™ Advanced is an image-processing software indicated to assist in the positioning of total hip replacement components, with a specific focus on the acetabular component. It is intended to assist in the precise positioning of the acetabular component intra-operatively by measuring its position relative to the bone structures of interest provided that the points of interest can be identified from radiology images. The device allows for overlaying of digital annotations on radiological images and includes tools for performing measurements using the images and digital annotations. Clinical judgment and experience are required to properly use the software. The software is not for primary image interpretation. The software is not for use on mobile phones.

Source page: https://510kreport.com/device/K231503
Methodology: https://510kreport.com/methodology