# Bonebridge AG

- Location (FDA's records): Zug, CH
- FDA decisions: 10 (2021–2026): 10 510(k) clearances
- Product codes: HRS (10)
- 510(k) review time since 2016: median 84 days, against 93 for FDA's reviews in the same codes and years (5 of 10 faster)
- Predicates its devices cite: 52 (13 its own); citations of its devices by later devices: 13 (13 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Synthes (Usa): 30 (https://510kreport.com/company/synthes-usa)
- Medartis AG: 4 (https://510kreport.com/company/medartis)
- Howmedica Osteonics Corp.: 2 (https://510kreport.com/company/howmedica-osteonics)
- Synthes (USA) Products, LLC: 2 (https://510kreport.com/company/synthes-usa-products)
- DePuy Synthes: 1 (https://510kreport.com/company/depuy-synthes)

## Its most-cited devices
- K231292: TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE 3.5mm Distal Humerus System (2023), cited by 4
- K213864: Bonebridge Osteosynthesis Plating System (2022), cited by 2
- K240318: SITTER 3.5mm Versatile System (2024), cited by 2
- 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 (2021), cited by 2
- K250933: LORRAINE 2.5/3.5mm Distal Humerus System (2025), cited by 1
- K243308: Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, LEPORELLO 3.5mm Olecranon Syste) (2024), cited by 1

## Recent decisions
- K261351: SALGINA 2.5mm Distal Radius System (Jun 26, 2026)
- K260228: POYA 3.5mm Medial Proximal Tibia System (Apr 24, 2026)
- K252191: BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus System (Dec 17, 2025)
- K250933: LORRAINE 2.5/3.5mm Distal Humerus System (Jun 11, 2025)
- K243308: Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, LEPORELLO 3.5mm Olecranon Syste) (Dec 20, 2024)
- K242399: Bonebridge Osteosynthesis Plating System (Oct 31, 2024)
- K240318: SITTER 3.5mm Versatile System (Aug 23, 2024)
- K231292: TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE 3.5mm Distal Humerus System (Jul 19, 2023)

Source page: https://510kreport.com/company/bonebridge