# K242399: Bonebridge Osteosynthesis Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Bonebridge AG
- Decided: Oct 31, 2024 after 79 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). 134 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 136 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240318: SITTER 3.5mm Versatile System, Bonebridge AG (2024). Cleared while this submission was under review Summary page 6.
- K082624: Synthes (Usa) 3.5MM LCP Posteromedial Proximal Tibia Plates, Synthes (Usa) (2008) 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.
- K032269: Synthes (Usa) 3.5/4.5MM LCP Medial Proximal Tibia Plates, Synthes (Usa) (2003) Summary page 6.
- K120854: Synthes VA LCP Ankle Trauma System, Synthes USA (2012) Summary page 6.
- K011335: Synths One-Third Tubular DCL Plate, Synthes (Usa) (2001) Summary page 6.
- 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 5.

## Most influential descendants
- K260228: POYA 3.5mm Medial Proximal Tibia System (2026), 0 descendants of its own

## Indications for use
POYA 3.5mm Posteromedial Tibia System The Bonebridge POYA 3.5mm Posteromedial Tibia System is intended for adult patients and indicated for internal fixation of posteromedial proximal tibia fractures, including buttressing of fractures of the proximal and metaphyseal areas of the tibia. Additionally, the longer plates are indicated for fractures extending to the tibial shaft. POYA 3.5mm Medial Proximal Tibia System The POYA 3.5mm Medial Proximal Tibia System is intended for adult patients and indicated to buttress metaphyseal fractures of the medial tibia plateau, split- type fractures of the medial tibia plateau, medial split fractures with associated depressions and split or depression fractures of the medial tibia plateau. Also, for use in the fixation of osteopenic bone and fixation of nonunions and malunions of the medial proximal tibia. SALTI 2.5/3.5mm Ankle System The SALTI 2.5/3.5mm Ankle System is intended for fixation of the ankle in adult patients and particularly in osteopenic bone. Specifically, * The Medial and Anterolateral Distal Tibia Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal tibia. » The Posterior Distal Tibia Plate is intended to buttress partial articular fractures and bone fragments of the distal tibia. * The Lateral Distal Fibula Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal fibula.

Source page: https://510kreport.com/device/K242399
Methodology: https://510kreport.com/methodology