# K243368: Montblanc Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Medifield Medical Co., Ltd.
- Decided: Jun 4, 2025 after 217 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: 11 generations back to K000684 (2000). 102 ancestors in all.
No later device cites it as a predicate yet.
0 of 103 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222267: Arthrex 2.4 mm Volar Distal Radius Plate System, Arthrex, Inc. (2022) Summary page 5.
- K123241: Arthrex Fracture Plates, Arthrex, Inc. (2013) Summary page 5.

## Indications for use
Montblanc Radius Plate System The Montblanc Radius Plate System is intended for internal fixation for fractures and reconstruction of the small bones, primarily including the distal radius and distal ulna. Examples of these internal fixations and reconstructions include compression fractures, intra-articular and extra-articular fractures, displaced fractures, osteotomies, non-unions and malunions. This system can be used for palmar, dorsal or orthogonal application. Montblanc Ankle Plate System The Montblanc Ankle Plate System is intended to be used for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the distal tibia and fibula.

Source page: https://510kreport.com/device/K243368
Methodology: https://510kreport.com/methodology