# K233761: Orthopaedic Surgery Planning Software (AIJOINT)

- Pathway: 510(k) (Traditional)
- Applicant: Longwood Valley Medical, Ltd.
- Decided: Aug 5, 2024 after 255 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: 9 generations back to K896095 (1990). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182464: PeekMed, Peek Health, S.A. (2018) Summary page 5.

## Indications for use
This product is used in medical institutions, it can carry out 3D reconstruction, segmentation and semi-automatic identification of key points on CT images conforming to DICOM3.0 standard format, and assist physicians to overlay digital templates to assist surgeons with preoperative planning of adult hip and total knee replacement surgery. This product is intended for use by trained and qualified physicians and cannot be used as a basis for clinical diagnosis and treatment decisions alone.

Source page: https://510kreport.com/device/K233761
Methodology: https://510kreport.com/methodology