# K032269: Synthes (Usa) 3.5/4.5MM LCP Medial Proximal Tibia Plates

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Sep 17, 2003 after 56 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.
12 later devices descend from it; 8 cite it directly.
0 of 13 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) Large Fragment LCP T- Plate: named in the summary without a submission number

## Most influential descendants
- K191793: Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand of DHS Plating System (2019), 3 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
- K242399: Bonebridge Osteosynthesis Plating System (2024), 1 descendant of its own
- K222282: HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System (2022), 1 descendant of its own

## Indications for use
The Synthes (USA) 3.5 / 4.5 mm LCP Medial Proximal Tibia Plates are intended to buttress metaphyseal fractures of the medial tibia plateau, split-type fractures of the medial tibia plateau, medial split fractures with associated depressions and split or depression fractures of the medial tibia plateau. Also, for use in the fixation of osteopenic bone and fixation of nonunions and malunions of the medial proximal tibia and tibia shaft.

Source page: https://510kreport.com/device/K032269
Methodology: https://510kreport.com/methodology