# K013415: Synthes Ankle Arthrodesis Plate

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Jan 11, 2002 after 88 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.
78 later devices descend from it; 1 cites it directly.
0 of 79 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 “000005”, which our checks could not confirm as its predicate.

## Most influential descendants
- K022255: Modofocation to Synthes Ankle Arthrodesis Plates (2002), 77 descendants of its own
- K060473: TTC Plate (2006), 76 descendants of its own
- K073375: Newdeal Tibiaxys System (2008), 73 descendants of its own
- K110670: VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws, Peri-Loc Ankle Fusion Plates (2011), 69 descendants of its own
- K100176: Ascension Ankle Fusion Plate System (2010), 56 descendants of its own

## Indications for use
The Synthes Ankle Arthrodesis Plate is intended for arthrodesis of the ankle joint and distal tibia.

Source page: https://510kreport.com/device/K013415
Methodology: https://510kreport.com/methodology