# K133930: Flower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower Rearfoot Plating Set

- Pathway: 510(k) (Traditional)
- Applicant: Flower Orthopedics Corporation
- Decided: Mar 27, 2014 after 94 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K010612 (2001). 128 ancestors in all.
No later device cites it as a predicate yet.
0 of 129 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991407: Synthes Locking Calcaneal Plates, Synthes (Usa) (1999) Summary page 1.
- K110670: VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws, Peri-Loc Ankle Fusion Plates, Smith & Nephew, Inc. (2011) Summary page 1.
- K090675: Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories, Smith & Nephew, Inc. (2009) Summary page 1.
- K120667: VLP 2.7MM Extra Large Percutaneous Calcaneus Plate, Peri-Loc 3.5MM Anterior Ankle Fusion Plates, Peri-Loc 3.5MM Hindfoot, Smith & Nephew, Inc. (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.

## Recalls of this device
- Jul 8, 2020 · Class II · Z-2782-2020: The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure titanium).
- Jul 8, 2020 · Class II · Z-2784-2020: The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure titanium).
- Jul 8, 2020 · Class II · Z-2785-2020: The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure titanium).
- Jul 8, 2020 · Class II · Z-2787-2020: The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure titanium).
- Jul 8, 2020 · Class II · Z-2786-2020: The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure titanium).
- Jul 8, 2020 · Class II · Z-2783-2020: The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure titanium).

## Indications for use
The Flower Rearfoot Plating Set is intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the calcaneus. Examples of these Internal fixations and reconstructions include, but are not limited to extra-articular fractures, intra-articular fractures, joint depression fractures, tongue type fractures, severely comminuted fractures and osteotomies.

Source page: https://510kreport.com/device/K133930
Methodology: https://510kreport.com/methodology