# K250933: LORRAINE 2.5/3.5mm Distal Humerus System

- Pathway: 510(k) (Traditional)
- Applicant: Bonebridge AG
- Decided: Jun 11, 2025 after 75 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: 13 generations back to K962616 (1996). 119 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 121 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231292: TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE 3.5mm Distal Humerus System, Bonebridge AG (2023) Summary page 6.
- K120070: Synthes Variable Angle LCP Elbow System, Synthes USA (2012) Summary page 6.
- K101056: Variax Elbow System, Howmedica Osteonics Corp. (2010) 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.
- 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, Bonebridge AG (2021) Summary page 6.
- K213864: Bonebridge Osteosynthesis Plating System, Bonebridge AG (2022) Summary page 6.

## Most influential descendants
- K252191: BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus System (2025), 0 descendants of its own

## Indications for use
The LORRAINE 2.5/3.5mm Distal Humerus System is indicated for intra-articular or extra-articular fractures of the distal humerus, supracondylar fractures, osteotomies, and non-unions. Longer plates may be used for distal humerus fractures with diaphyseal extension.

Source page: https://510kreport.com/device/K250933
Methodology: https://510kreport.com/methodology