# K023802: Synthes 4.5 MM Titanium LCP Proximal Tibia Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Jan 28, 2003 after 75 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.
68 later devices descend from it; 8 cite it directly.
0 of 69 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 Plating System: named in the summary without a submission number
- (no number) Synthes Large Fragment LCP T- Plate: named in the summary without a submission number

## Most influential descendants
- K061211: NCB Plating System, Proximal Tibia Plates (2006), 25 descendants of its own
- K153716: GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System. (2016), 15 descendants of its own
- K163361: ANTHEM™ Fracture System (2017), 14 descendants of its own
- K192217: NCB Plating System Distal Femur and Proximal Tibia (2019), 11 descendants of its own
- K171904: Tandry Locking Plate System (2018), 11 descendants of its own

## Indications for use
The Synthes 4.5 mm Titanium LCP Proximal Tibia System is intended for treatment of nonunions, malunions, and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression medial wedge, bicondylar combination of lateral wedge and depression, and fractures with associated shaft fractures.

Source page: https://510kreport.com/device/K023802
Methodology: https://510kreport.com/methodology