# K260090: SMART Osteotomy System

- Pathway: 510(k) (Traditional)
- Applicant: Actis Medical Pty., Ltd.
- Decided: Apr 10, 2026 after 88 days
- Product code: HRS (Plate, Fixation, Bone)
- 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: 2 generations back to K000682 (2000). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141796: Depuy Synthes Tomofix Osteotomy System, Synthes (USA) Products, LLC (2014) Summary page 6.

## Indications for use
The SMART Osteotomy plates are intended for use in open and closed wedge osteotomies of the medial proximal tibia, lateral proximal tibia, medial distal femur and lateral distal femur, treatment of bone and joint deformities, fractures and malalignment caused by injury or disease such as osteoarthritis. The system is intended for skeletally mature patients only.

Source page: https://510kreport.com/device/K260090
Methodology: https://510kreport.com/methodology