# K111540: Synthes 3.5MM LCP Clavicle Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Aug 8, 2011 after 67 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: 2 generations back to K000684 (2000). 3 ancestors in all.
45 later devices descend from it; 10 cite it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101536: 2.7/3.5MM VA-LCP Anteriro Clavicle Plate System, Synthes (Usa), LLC (2010) Summary page 1.
- K073186: Synthes 3.5MM LCP Clavicle Plate System, Synthes (Usa) (2007) Summary page 1.
- K000684: Small Fragment Dynamic Compression Locking (DCL) System, Synthes (Usa) (2000) Summary page 1.

## Most influential descendants
- K173166: ANTHEM Fracture System (2017), 11 descendants of its own
- K180554: ANTHEM Fracture System (2018), 10 descendants of its own
- K213864: Bonebridge Osteosynthesis Plating System (2022), 8 descendants of its own
- K202496: ANTHEM Fracture System (2020), 8 descendants of its own
- K231292: TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE 3.5mm Distal Humerus System (2023), 7 descendants of its own

## Indications for use
The Synthes 3.5mm LCP Clavicle Plate System is indicated for fixation of fractures, malunions, non-unions, and osteotomies of the clavicle in adults, and in both adolescents (12-18 years) and transitional adolescents (18-21 years), in which the clavicular growth plates have fused or in which the growth plates will not be crossed by the plate system.

Source page: https://510kreport.com/device/K111540
Methodology: https://510kreport.com/methodology