# K243308: Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, LEPORELLO 3.5mm Olecranon Syste)

- Pathway: 510(k) (Traditional)
- Applicant: Bonebridge AG
- Decided: Dec 20, 2024 after 60 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: 14 generations back to K962616 (1996). 126 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 128 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240318: SITTER 3.5mm Versatile System, Bonebridge AG (2024) Summary page 5.
- K142906: APTUS Wrist 2.5 System, Medartis AG (2015) Summary page 6.
- K191848: APTUS Wrist Spanning Plates 2.5, Medartis AG (2019) 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.
- K102694: 2.4MM VA-LCP Dorsal Distal Radius Plates, Synthes (Usa) (2010) Summary page 6.
- K073186: Synthes 3.5MM LCP Clavicle Plate System, Synthes (Usa) (2007) Summary page 6.
- K000684: Small Fragment Dynamic Compression Locking (DCL) System, Synthes (Usa) (2000) Summary page 6.
- K120070: Synthes Variable Angle LCP Elbow System, Synthes USA (2012) Summary page 6.

## Most influential descendants
- K261351: SALGINA 2.5mm Distal Radius System (2026), 0 descendants of its own

## 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 The CASCELLA 3.5mm Superior Clavicle System is indicated for: • fixation of fractures of the clavicle shaft • fixation of fractures of the lateral clavicle • malunions of the clavicle • non-unions of the clavicle The LEPORELLO 3.5mm Olecranon System is indicated for • fractures • osteotomies • nonunions of the olecranon and proximal ulna.

Source page: https://510kreport.com/device/K243308
Methodology: https://510kreport.com/methodology