# K240318: SITTER 3.5mm Versatile System

- Pathway: 510(k) (Traditional)
- Applicant: Bonebridge AG
- Decided: Aug 23, 2024 after 203 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: 13 generations back to K962616 (1996). 119 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 124 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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 4.
- K082807: Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded Indications, Synthes (Usa) (2008) Summary page 5.

## Most influential descendants
- 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
- K261351: SALGINA 2.5mm Distal Radius System (2026), 0 descendants of its own
- K260228: POYA 3.5mm Medial Proximal Tibia System (2026), 0 descendants of its own

## Indications for use
The SITTER 3.5mm Versatile System is indicated for fixation of fractures, osteotomies and nonunions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula in adult patients with normal or osteopenic bone.

Source page: https://510kreport.com/device/K240318
Methodology: https://510kreport.com/methodology