# K013248: Synthes LCP Distal Tibia Plates

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Dec 19, 2001 after 82 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.
116 later devices descend from it; 20 cite it directly.
0 of 117 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 no predicate by number.

## Most influential descendants
- K092812: Synthes (Usa) 2.7MM/ 3.5MM LCP Anterolateral Distal Tibia Plates (2010), 55 descendants of its own
- K141121: Axsos 3 TI Locking Plate System (2014), 26 descendants of its own
- K153379: AxSOS 3Ti (2016), 25 descendants of its own
- K063672: Fibula Plate Prolock with Angular Stability (2007), 25 descendants of its own
- K162439: AxSOS 3 Ti; Stryker Plating System (2017), 24 descendants of its own

## Indications for use
The Synthes Locking Compression Plate (LCP) System is intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula, particularly in osteopenic bone. The Synthes LCP Distal Tibia Plates are intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal tibia and other small bones as a part of the Synthes Small Fragment LCP System.

Source page: https://510kreport.com/device/K013248
Methodology: https://510kreport.com/methodology