# K203002: SALGINA 2.5mm Volar Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, TAMlNA 3.5mm Proximal Humerus System, TRIFT 3.5mm 1/3 Tubular System

- Pathway: 510(k) (Traditional)
- Applicant: Bonebridge AG
- Decided: Oct 5, 2021 after 369 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 K000684 (2000). 2 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011335: Synths One-Third Tubular DCL Plate, Synthes (Usa) (2001) Summary page 5.

## Most influential descendants
- K213864: Bonebridge Osteosynthesis Plating System (2022), 8 descendants of its own
- K231292: TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE 3.5mm Distal Humerus System (2023), 7 descendants of its own
- K240318: SITTER 3.5mm Versatile System (2024), 4 descendants of its own
- K250933: LORRAINE 2.5/3.5mm Distal Humerus System (2025), 1 descendant of its own
- K243308: Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, LEPORELLO 3.5mm Olecranon Syste) (2024), 1 descendant of its own

## Indications for use
The TRIFT 3.5mm 1/3 Tubular Plate is indicated for: * Treatment of smaller fractures of long bones such as humerus, fibula, and ulna

Source page: https://510kreport.com/device/K203002
Methodology: https://510kreport.com/methodology