# K133102: Flower Ankle Plating Set

- Pathway: 510(k) (Traditional)
- Applicant: Flower Orthopedics Corporation
- Decided: Nov 18, 2013 after 49 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
Longest line of descent: 14 generations back to K962616 (1996). 122 ancestors in all.
No later device cites it as a predicate yet.
0 of 123 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083213: Synthes 2.7 MM/3.5 MM LCP Distal Fibula Plates, Synthes (Usa) (2008) Summary page 1.
- K120854: Synthes VA LCP Ankle Trauma System, Synthes USA (2012) Summary page 1.
- K121601: Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma System-Anterolateral Distal Tibia Plate, Synthes USA (2012) Summary page 1.
- K123562: Flower Small and Medium Bone Implants, Flower Orthopedics Corporation (2013) Summary page 1.
- K131657: Flower Small and Medium Implant Set, Flower Orthopedics Corporation (2013) Summary page 1.

## Indications for use
The Flower Ankle Plating Set is intended for use for fixation of the ankle in adults and adolescents (12-21) in whom the growth plates have fused, and particularly in osteopenic bone. Specifically, * Distal Medial and Lateral Tibia Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal tibia, * Distal Tibia A-Plates are intended to buttress partial articular fractures and bone fragments of the distal tibia, and * Straight and Distal Lateral Fibula Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal fibula.

Source page: https://510kreport.com/device/K133102
Methodology: https://510kreport.com/methodology