# K082625: Synthes (Usa) 3.5MM LCP Periarticular Proximal Humerus Plates

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Dec 17, 2008 after 99 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
35 later devices descend from it; 10 cite it directly.
0 of 36 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 LCP Proximal Humerus Plates: named in the summary without a submission number
- (no number) Synthes Small Fragment Dynamic Compression Locking Plates: named in the summary without a submission number

## Most influential descendants
- 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
- K212433: Anthem Fracture System (2021), 7 descendants of its own

## Recalls of this device
- Sep 16, 2010 · Not classified · Z-0309-2011: screw can pass through plate hole

## Indications for use
Synthes 3.5mm Periarticular Proximal Humerus Plates are indicated for fractures, fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone.

Source page: https://510kreport.com/device/K082625
Methodology: https://510kreport.com/methodology