# K061940: Synthes LCP Ankle Arthrodesis Plates

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Sep 8, 2006 after 60 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.
59 later devices descend from it; 4 cite it directly.
0 of 60 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 Ankle Arthrodesis Plates: named in the summary without a submission number

## Most influential descendants
- K100176: Ascension Ankle Fusion Plate System (2010), 56 descendants of its own
- K090139: Ankle Arthrodesis Plate System (2009), 54 descendants of its own
- K121425: Ortholoc 3DI Ankle Fusion Plating System (2012), 53 descendants of its own
- K140397: Paralock Plating System / Tuffnek Screw (2014), 31 descendants of its own
- K163650: ORTHOLOC® 3Di Ankle Fusion Plating System Line Extension (2017), 12 descendants of its own

## Indications for use
Synthes LCP Ankle Arthrodesis Plates are intended for arthrodesis of the ankle joint and distal tibia.

Source page: https://510kreport.com/device/K061940
Methodology: https://510kreport.com/methodology