# K020602: Synthes Pilon Plate

- Pathway: 510(k) (Traditional)
- Applicant: Synthes
- Decided: May 20, 2002 after 87 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.
72 later devices descend from it; 4 cite it directly.
0 of 73 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. Our reading found no predicate number; beside “510(k)” the summary reads “000004”, which our checks could not confirm as its predicate.

## Most influential descendants
- K092812: Synthes (Usa) 2.7MM/ 3.5MM LCP Anterolateral Distal Tibia Plates (2010), 55 descendants of its own
- K162674: BioPro Foot Plating Systems (2017), 19 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
- K193633: APTUS® Ankle Trauma System 2.8/3.5 (2020), 11 descendants of its own

## Indications for use
The Synthes Pilon Plate is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal tibia.

Source page: https://510kreport.com/device/K020602
Methodology: https://510kreport.com/methodology