# K020401: Synthes Calcaneal Plate

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: May 8, 2002 after 90 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.
132 later devices descend from it; 12 cite it directly.
0 of 133 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
- K033639: Acumed Lower Extremity Congruent Plate System (2004), 98 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
- K121425: Ortholoc 3DI Ankle Fusion Plating System (2012), 53 descendants of its own

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

Source page: https://510kreport.com/device/K020401
Methodology: https://510kreport.com/methodology