# K213864: Bonebridge Osteosynthesis Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Bonebridge AG
- Decided: Sep 2, 2022 after 266 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: 11 generations back to K962616 (1996). 109 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 118 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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 5.
- K142906: APTUS Wrist 2.5 System, Medartis AG (2015) Summary page 6.
- K051567: Aptus Titanium Osteosynthesis System, Medartis, Inc. (2005) Summary page 6.
- K111540: Synthes 3.5MM LCP Clavicle Plate System, Synthes (Usa) (2011) Summary page 6.
- K073186: Synthes 3.5MM LCP Clavicle Plate System, Synthes (Usa) (2007) Summary page 6.
- K011815: Synthes LCP Proximal Humerus Plates, Synthes (Usa) (2001) Summary page 6.
- K120689: Synthes 3.5 MM VA-LCP Proximal Tibia Plate System, Synthes (USA) Products, LLC (2012) Summary page 6.
- K082624: Synthes (Usa) 3.5MM LCP Posteromedial Proximal Tibia Plates, Synthes (Usa) (2008) Summary page 6.
- K092247: Synthes Locking Hand Plates, Synthes (Usa) (2009) Summary page 6.
- K120070: Synthes Variable Angle LCP Elbow System, Synthes USA (2012) Summary page 6.

## Most influential descendants
- K231292: TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE 3.5mm Distal Humerus System (2023), 7 descendants of its own
- 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

## Indications for use
The SALGINA® 2.5mm Volar Distal Radius System is indicated for » Intra-articular fractures of the Distal Radius » Extra-articular fractures of the Distal Radius The CASCELLA® 3.5mm Superior Clavicle System is indicated for: » fixation of fractures of the clavicle shaft » fixation of fractures of the lateral clavicle » malunions of the clavicle » non-unions of the clavicle The TAMINA® 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 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 The POYA® 3.5mm Posteromedial Tibia System is indicated for internal fixation of posteromedial proximal tibia fractures including buttressing of fractures of the proximal areas of the tibia. The DALVAZZA® 2.5mm Distal Ulna System is indicated for » fixation of fractures * nonunions of the distal ulna. The LEPORELLO® 3.5mm Olecranon System is indicated for » fractures * osteotomies * non-unions of the olecranon and proximal ulna.

Source page: https://510kreport.com/device/K213864
Methodology: https://510kreport.com/methodology