# K261641: Lower Limb AI (LLAI)

- Pathway: 510(k) (Traditional)
- Applicant: AI Planning Logic, Inc.
- Decided: Aug 18, 2026 after 92 days
- Product code: QIH (Automated Radiological Image Processing Software)
- 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: 14 generations back to K896095 (1990). 36 ancestors in all.
No later device cites it as a predicate yet.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240642: SMART Bun-Yo-Matic CT, Disior, Ltd. (2024) Summary page 5.
- K252856: PeekMed web, Peek Health, S.A. (2025) Summary page 5.

## Indications for use
The Al Planning Logic (AIPL) Lower Limb Al (LLAI) is software intended for use by orthopedic healthcare professionals in the preoperative planning of knee osteotomy procedures. The device processes CT images of the lower limb to provide: » Automated segmentation and 3D reconstruction of bony anatomy » Quantitative measurement of lower limb alignment, including mechanical and anatomical axis angles » Visualization of anatomical structures and surgical planning outcomes in a virtual 3D environment The software is intended to be used as an adjunctive tool to support clinical judgment and is not intended to provide diagnostic information or to replace the surgeon’s decision-making process.

Source page: https://510kreport.com/device/K261641
Methodology: https://510kreport.com/methodology