# K142306: Flower Upper Extremity Plating Set

- Pathway: 510(k) (Traditional)
- Applicant: Flower Orthopedics Corporation
- Decided: Sep 15, 2014 after 27 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: 7 generations back to K954385 (1996). 60 ancestors in all.
No later device cites it as a predicate yet.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012655: Congruent Bone Plate System, Acu Med, Inc. (2001) Summary page 4.
- K063460: Acumed Congruent Bone Plate System, Acumed, LLC (2006). Our reading of the summary gave K063640, FDA’s number for Kowa SL-15 (Kowa Co., Ltd.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Acumed Inc., Congruent Bone Plating System”.
- K071715: Acumed Congruent Bone Plate System, Acumed, LLC (2007) Summary page 4.
- K123562: Flower Small and Medium Bone Implants, Flower Orthopedics Corporation (2013) Summary page 4.
- K131657: Flower Small and Medium Implant Set, Flower Orthopedics Corporation (2013) Summary page 4.

## Indications for use
The Flower Upper Extremity Plating Set is intended to be used for fixation of fractures, fusions, or osteotomies of the clavicle, humerus, radius and ulna.

Source page: https://510kreport.com/device/K142306
Methodology: https://510kreport.com/methodology