# K231292: TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE 3.5mm Distal Humerus System

- Pathway: 510(k) (Traditional)
- Applicant: Bonebridge AG
- Decided: Jul 19, 2023 after 76 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: 12 generations back to K962616 (1996). 118 ancestors in all.
7 later devices descend from it; 4 cite it directly.
0 of 126 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213864: Bonebridge Osteosynthesis Plating System, Bonebridge AG (2022) Summary page 4.
- K041860: Synthes (Usa) LCP Proximal Humerus Plates, Long, Synthes (Usa) (2004) Summary page 5.
- K011815: Synthes LCP Proximal Humerus Plates, Synthes (Usa) (2001) Summary page 5.
- K082807: Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded Indications, Synthes (Usa) (2008) Summary page 5.
- K120689: Synthes 3.5 MM VA-LCP Proximal Tibia Plate System, Synthes (USA) Products, LLC (2012) Summary page 5.
- K120070: Synthes Variable Angle LCP Elbow System, Synthes USA (2012) Summary page 5.
- K101056: Variax Elbow System, Howmedica Osteonics Corp. (2010) Summary page 5.

## Most influential descendants
- 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
- K242399: Bonebridge Osteosynthesis Plating System (2024), 1 descendant of its own
- K261351: SALGINA 2.5mm Distal Radius System (2026), 0 descendants of its own

## Indications for use
TAMINA 3.5mm Proximal Humerus System 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 POYA 3.5mm Lateral Proximal Tibia System The POYA 3.5mm Lateral Proximal Tibia System is indicated for the internal fixation of fractures of the proximal tibia in adults and skeletally mature adolescents including: • simple fractures • comminuted fractures • lateral wedge, medial wedge as well as bicondylar combination of lateral and medial wedge fractures • depression fractures • periprosthetic fractures • nonunions, malunions, tibial osteotomies and osteopenic bone • fractures with associated shaft fractures LORRAINE 3.5mm Distal Humerus System The LORRAINE 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/K231292
Methodology: https://510kreport.com/methodology