# K240113: CORIOGRAPH Knee Pre-Op Plan

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Mar 18, 2024 after 62 days
- Product code: PBF (Orthopaedic Surgical Planning And Instrument Guides)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 22 generations back to K905070 (1991). 100 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 103 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211512: VISIONAIRE UK Patient Matched Cutting Guides, Smith & Nephew, Inc. (2021) Summary page 4.
- K221224: Real Intelligence Cori, Blue Belt Technologies, Inc. (2022) Summary page 7.

## 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

## Indications for use
Intended Use CORIOGRAPH Pre-Op Planning and Modeling Service is intended to provide pre-operative planning for surgical procedures based on patient imaging, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. Indications for Use The CORIOGRAPH Pre-op Planning and Modeling Service is indicated for use for the following procedures: * unicondylar knee replacement (UKR) * total knee arthroplasty (TKA)

Source page: https://510kreport.com/device/K240113
Methodology: https://510kreport.com/methodology