# K252191: BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus System

- Pathway: 510(k) (Traditional)
- Applicant: Bonebridge AG
- Decided: Dec 17, 2025 after 156 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). 146 ancestors in all.
No later device cites it as a predicate yet.
0 of 147 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K250933: LORRAINE 2.5/3.5mm Distal Humerus System, Bonebridge AG (2025) Summary page 6.
- K233665: DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment Plating System, DePuy Synthes (2024) Summary page 6.
- K063049: Synthes (Usa) Modular Mini Fragment LCP System, Synthes (Usa) (2006) Summary page 6.
- K041860: Synthes (Usa) LCP Proximal Humerus Plates, Long, Synthes (Usa) (2004) Summary page 6.
- K011815: Synthes LCP Proximal Humerus Plates, Synthes (Usa) (2001) 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 BRUSIO Trauma Toolbox System is indicated for internal fixation of fractures, osteotomies and nonunions of bones and bone fragments of the appendicular skeleton that are appropriate for the implant size in adult patients. When used in the clavicle, scapula, humerus, olecranon, pelvis, femur, tibia or fibula, the BRUSIO Trauma Toolbox System is intended only for non-load-bearing stabilization and reduction. The TAMINA, TAMINA Long and TAMINA TF Proximal Humerus System is indicated for • Dislocated two-, three-, and four fragment fractures of the proximal humerus including fractures involving osteopenic bone • Pseudarthroses (non-unions) of the proximal humerus • Osteotomies of the proximal humerus

Source page: https://510kreport.com/device/K252191
Methodology: https://510kreport.com/methodology