# K052390: Synthes LCP Proximal Tibia Plates Line Extension

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Oct 7, 2005 after 37 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.
53 later devices descend from it; 5 cite it directly.
0 of 54 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 LCP Proximal Tibia Plates: named in the summary without a submission number

## Most influential descendants
- K120689: Synthes 3.5 MM VA-LCP Proximal Tibia Plate System (2012), 28 descendants of its own
- K123964: Axsos 3 TI Locking Plate System (2013), 19 descendants of its own
- K133440: Axsos 3 TI Locking Plate System Line Extension (2013), 12 descendants of its own
- K173166: ANTHEM Fracture System (2017), 11 descendants of its own
- K180554: ANTHEM Fracture System (2018), 10 descendants of its own

## Indications for use
The Synthes LCP Proximal Tibia System is intended for treatment of nonunions, malunions, osteopenic bone, tibial osteotomies (4.5mm plate only), and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of lateral wedge and depression, periprosthetic, and fractures with associated shaft fractures.

Source page: https://510kreport.com/device/K052390
Methodology: https://510kreport.com/methodology