Class Class II
Bonebridge Osteosynthesis Plating System (K242399)
Description
Bonebridge Osteosynthesis Plating System by Bonebridge AG, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242399
Clearance Date2024-10-31
Clearance TypeTraditional
Product CodeHRS
Regulation Number888.3030
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242399
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Bonebridge Osteosynthesis Plating System (K242399) cites 6 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K240318 | SITTER 3.5mm Versatile System | Bonebridge AG | 2024 |
| K231292 | TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Pr... | Bonebridge AG | 2023 |
| K120854 | SYNTHES VA LCP ANKLE TRAUMA SYSTEM | Synthes USA | 2012 |
| K082807 | SYNTHES (USA) 3.5 AND 4.5 MM LOCKING COMPRESSION PLATE SYST... | Synthes (Usa) | 2008 |
| K082624 | SYNTHES (USA) 3.5MM LCP POSTEROMEDIAL PROXIMAL TIBIA PLATES | Synthes (Usa) | 2008 |
| K032269 | SYNTHES (USA) 3.5/4.5MM LCP MEDIAL PROXIMAL TIBIA PLATES | Synthes (Usa) | 2003 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K260228 | POYA 3.5mm Medial Proximal Tibia System | Bonebridge AG | 2026 |
Trace the full predicate network for K242399
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.