# K050646: Synthes (Usa) 3.5/4.5MM LCP Medial Proximal Tibia Plates

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Apr 26, 2005 after 43 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.
37 later devices descend from it; 8 cite it directly.
0 of 38 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) 3.5 / 4.5mm LCP Medial Proximal Tibia Plates: named in the summary without a submission number

## Most influential descendants
- K141121: Axsos 3 TI Locking Plate System (2014), 26 descendants of its own
- K153379: AxSOS 3Ti (2016), 25 descendants of its own
- K162439: AxSOS 3 Ti; Stryker Plating System (2017), 24 descendants of its own
- K172350: AxSOS 3 Ti (2017), 17 descendants of its own
- K181091: AxSOS 3 Ti (2018), 11 descendants of its own

## Indications for use
The Synthes (USA) 3.5 / 4.5mm 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. The plates may also be used for fixation of the proximal quarter (lateral and medial) of the tibia as well as segmental fractures of the proximal tibia. The 4.5mm version may also be used for fixation of nonunions and malunions of the medial proximal tibia and tibia shaft, as well as opening and closing wedge tibial osteotomies.

Source page: https://510kreport.com/device/K050646
Methodology: https://510kreport.com/methodology