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TAMINA 3.5mm Proximal Humerus System - LORRAINE 3.5mm Distal Humerus System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K231292

by Bonebridge AG

Identifiers

510(k) Number
K231292 FDA 510(k)
FDA Product Code
HRS FDA 510(k)
Models / Variants
TAMINA 3.5mm Proximal Humerus System FDA 510(k)
POYA 3.5MM Lateral Proximal Tibia System FDA 510(k)
LORRAINE 3.5mm Distal Humerus System FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3030 FDA 510(k)
Regulation Number
888.3030 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The TAMINA 3.5mm Proximal Humerus System, POYA 3.5mm Lateral Proximal Tibia System, and LORRAINE 3.5mm Distal Humerus System are orthopedic fixation devices designed for fracture management in specific anatomical locations. These systems are indicated for treating dislocated two-, three-, and four-fragment fractures of the proximal humerus, pseudarthroses of the proximal humerus, and osteotomies of the proximal humerus, as well as lateral proximal tibia fractures.

These devices are supplied by Bonebridge AG and have received FDA 510(k) clearance with the product code HRS. The systems are intended for use in orthopedic surgical procedures and are available in various sizes to accommodate different anatomical requirements. The devices are manufactured in Zug, Switzerland, and are designed for single-use or multiple-use depending on the specific system configuration and clinical application.

Frequently asked questions

What are the TAMINA, POYA, and LORRAINE systems used for?

These orthopedic fixation devices are designed for treating dislocated two-, three-, and four-fragment fractures of the proximal humerus, pseudarthroses of the proximal humerus, osteotomies of the proximal humerus, and lateral proximal tibia fractures.

Are these devices single-use or reusable?

The systems are designed for either single-use or multiple-use depending on the specific system configuration and clinical application requirements.

What sizes are available for these fixation systems?

The systems are available in various sizes to accommodate different anatomical requirements, though specific size details are not provided in the available information.

What is the regulatory status of these devices?

These systems have received FDA 510(k) clearance with the product code HRS, indicating they are substantially equivalent to predicate devices for their intended uses.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia ..., Bonebridge - DOWNLOADS, Bonebridge - TAMINA & TAMINA TF

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Bonebridge AG

Sources (1)

  • FDA 510(k) K231292 24 fields · synced Oct 6, 2026