# K242973: CanMINI Hand and Foot System

- Pathway: 510(k) (Abbreviated)
- Applicant: Canwell Medical Co., Ltd.
- Decided: Apr 24, 2025 after 210 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: 9 generations back to K962616 (1996). 51 ancestors in all.
No later device cites it as a predicate yet.
0 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090047: Synthes (Usa) 1.5MM Mini Fragment LCP System, Synthes (Usa) (2009) Summary page 5.
- K130108: Double Engine Bone Plate and Screw Systems, Xiamen Double Engine Medical Material Co., Ltd. (2013) Summary page 6.
- K033639: Acumed Lower Extremity Congruent Plate System, Acumed, LLC (2004) Summary page 6.
- K063049: Synthes (Usa) Modular Mini Fragment LCP System, Synthes (Usa) (2006) Summary page 6.
- K092015: Peri-Loc Periarticular Locked Plating System, Smith & Nephew, Inc. (2009) Summary page 6.
- K191344: Arthrex Mini Comprehensive Fixation System – 2.0mm & 2.4mm Module, Arthrex, Inc. (2019) Summary page 6.
- K930834: Acutract, Acu Med, Inc. (1993) Summary page 7.
- K082807: Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded Indications, Synthes (Usa) (2008) Summary page 7.

## Indications for use
The CanMINI Hand and Foot System is indicated for fixation of small bones and small bone fragments in the hand and foot. The devices are intended to be single-use and sterilized before use.

Source page: https://510kreport.com/device/K242973
Methodology: https://510kreport.com/methodology