# K031178: Synthes (Usa) 3.5 MM Broad LCP & 4.5 MM LCP Distal Humerus Plates

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: May 5, 2003 after 21 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
No predicates in its family tree.
41 later devices descend from it; 2 cite it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Synthes 3.5 mm LCP Reconstruction Plate: named in the summary without a submission number

## Most influential descendants
- K041965: Arthrex Humeral Fracture Plates and Screws (2004), 35 descendants of its own
- K163361: ANTHEM™ Fracture System (2017), 14 descendants of its own
- K173166: ANTHEM Fracture System (2017), 11 descendants of its own
- K180554: ANTHEM Fracture System (2018), 10 descendants of its own
- K202496: ANTHEM Fracture System (2020), 8 descendants of its own

## Indications for use
The Synthes 3.5 mm Broad LCP & 4.5 mm LCP Distal Humerus Plates are indicated for fractures of the Distal Humerus.

Source page: https://510kreport.com/device/K031178
Methodology: https://510kreport.com/methodology