# K082624: Synthes (Usa) 3.5MM LCP Posteromedial Proximal Tibia Plates

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Nov 10, 2008 after 62 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
No predicates in its family tree.
20 later devices descend from it; 8 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Synthes (USA) 3.5mm / 4.5mm LCP Metaphyseal Plates: named in the summary without a submission number
- (no number) Synthes (USA) Large Fragment LCP System T Plates: named in the summary without a submission number

## Most influential descendants
- K213864: Bonebridge Osteosynthesis Plating System (2022), 8 descendants of its own
- 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
- K163383: GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND Of DHS/Dynamic Condylar Plate Plating System (2017), 3 descendants of its own
- K242939: ARTFX Trauma Bone Plate and Screw System (2024), 2 descendants of its own

## Indications for use
Synthes 3.5mm LCP Posteromedial Proximal Tibia Plates are indicated for internal fixation of posteromedial proximal tibia fractures including buttressing of fractures of the proximal, distal, and metaphyseal areas of the tibia.

Source page: https://510kreport.com/device/K082624
Methodology: https://510kreport.com/methodology