# K123562: Flower Small and Medium Bone Implants

- Pathway: 510(k) (Traditional)
- Applicant: Flower Orthopedics Corporation
- Decided: Mar 29, 2013 after 130 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K954385 (1996). 56 ancestors in all.
14 later devices descend from it; 7 cite it directly.
0 of 71 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082807: Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded Indications, Synthes (Usa) (2008) Summary page 1.
- K092609: Synthes 3.5 MM and 4.55 MM Curved Narrow and Broad Locking Compression Plates (LCP), Synthes (Usa) (2009) Summary page 1.
- K112455: Aiming Blocks for Variax Distal Radius Plates, Howmedica Osteonics Corp., Dba Stryker Orthopaedics (2011) Summary page 1.
- K040598: KLS Martin Hand Plating System, KLS-Martin L.P. (2004) Summary page 1.
- K103243: 2.4MM VA-LCP Intercarpal Fusion System, Synthes (Usa) (2011) Summary page 1.

## Most influential descendants
- K131657: Flower Small and Medium Implant Set (2013), 11 descendants of its own
- K152306: MotoBand¿ CP Implant System (2015), 7 descendants of its own
- K160300: MotoBand (TM) CP Implant System (2016), 6 descendants of its own
- K173710: MotoBAND CP Implant System (2018), 4 descendants of its own
- K193452: MotoBAND CP Implant System (2020), 3 descendants of its own

## Recalls of this device
- Sep 3, 2021 · Class II · Z-0034-2022: Product kit missing CDG 200 (Cannulated Countersink for 3.0-4.5mm Screws) from EWK 201 (Flower E-Kit, Advanced)
- Feb 16, 2015 · Class II · Z-1314-2015: Locking pegs were not locking during distal radius procedures. There has been one (1) report of revision surgery scheduled to remove a loosened peg.

## Indications for use
The Flower Small and Medium Implants set is intended for use for internal fixation of fractures and reconstruction of bones, including the scapula, olecranon, humerus, radius, ulna, pelvs, distal tibia, fibula, hand and foot in adults and for use in long bones in adolescents (12-21) in whom the growth plates have fused. Examples of these internal fixations and reconstructions include compression fractures, i ntra-articular and extraarticular fractures; displaced fractures, osteotomies, non-unions and mal-unions. This system can be used for palmar, ventral, dorsal or orthogonal application.

Source page: https://510kreport.com/device/K123562
Methodology: https://510kreport.com/methodology