# K092609: Synthes 3.5 MM and 4.55 MM Curved Narrow and Broad Locking Compression Plates (LCP)

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Nov 17, 2009 after 84 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: 4 generations back to K981372 (1998). 12 ancestors in all.
51 later devices descend from it; 11 cite it directly.
0 of 64 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.

## Most influential descendants
- K123562: Flower Small and Medium Bone Implants (2013), 14 descendants of its own
- K131657: Flower Small and Medium Implant Set (2013), 11 descendants of its own
- K113733: Small and Large Fragments Osteosynthesis System Neofix (2012), 11 descendants of its own
- K142419: Mini and Micro Fragments Reconstruction System-NEOFIX (2014), 8 descendants of its own
- K152306: MotoBand¿ CP Implant System (2015), 7 descendants of its own

## Indications for use
The Synthes 3.5mm Curved Narrow and Broad LCP Plates are intended for fixation of fractures, osteotomies and non-unions of clavicle, scapula, olecranon, humerus, radius, pelvis, distal tibia and fibula, particularly in osteopenic bone for adult patients. The Synthes 4.5mm Curved Narrow and Broad LCP Plates are intended for fixation of various long bones, such as the humerus, femur, and tibia. They are also for use in fixation of periprosthetic fractures, osteopenic bone, and non-unions or malunions in adult patients. The 3.5mm and 4.5mm Curved Narrow and Broad LCP Plates are also indicated for fracture fixation of diaphyseal and metaphyseal areas of long bones in pediatric patients.

Source page: https://510kreport.com/device/K092609
Methodology: https://510kreport.com/methodology