# K261351: SALGINA 2.5mm Distal Radius System

- Pathway: 510(k) (Traditional)
- Applicant: Bonebridge AG
- Decided: Jun 26, 2026 after 63 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: 15 generations back to K962616 (1996). 127 ancestors in all.
No later device cites it as a predicate yet.
0 of 128 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243308: Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, LEPORELLO 3.5mm Olecranon Syste), Bonebridge AG (2024) Summary page 6.
- K082807: Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded Indications, Synthes (Usa) (2008) Summary page 6.

## Indications for use
The SALGINA 2.5mm Distal Radius System is indicated for: - Intra-articular fractures of the distal radius - Extra-articular fractures of the distal radius - Fractures with associated radial shaft fractures

Source page: https://510kreport.com/device/K261351
Methodology: https://510kreport.com/methodology