# K011815: Synthes LCP Proximal Humerus Plates

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Sep 6, 2001 after 87 days
- Product code: KTW (Appliance, Fixation, Nail/Blade/Plate Combination, Single Component)
- 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.
185 later devices descend from it; 25 cite it directly.
0 of 186 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. Our reading found no predicate number; beside “510(k)” the summary reads “000005”, which our checks could not confirm as its predicate.
- (no number) Synthes Small Fragment Dynamic Compression Locking (DCL) System: named in the summary without a submission number
- (no number) De Puy Ace Symmetry Proximal Humerus Plate: named in the summary without a submission number

## Most influential descendants
- K083032: Peri-Loc Bone Plating and Screw System (2009), 77 descendants of its own
- K042695: NCB Plating System (2004), 68 descendants of its own
- K132886: Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System (2014), 46 descendants of its own
- K123055: Smith & Nephew, Inc Screw and Plate System Instrumentation (2013), 33 descendants of its own
- K140814: Evos Mini-Fragment Plating System (2014), 32 descendants of its own

## Indications for use
Synthes LCP Proximal Humerus Plate is indicated for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone.

Source page: https://510kreport.com/device/K011815
Methodology: https://510kreport.com/methodology