# K041911: Synthes (Usa) LCP Curved Plates

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Sep 8, 2004 after 55 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- 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.
237 later devices descend from it; 7 cite it directly.
0 of 238 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 Large Fragment Dynamic Compression System: named in the summary without a submission number
- (no number) Synthes Locking Condylar Plating System: named in the summary without a submission number

## Most influential descendants
- K082807: Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded Indications (2008), 186 descendants of its own
- K110354: 4.5MM VA-LCP Curved Condylar Plate System (2011), 62 descendants of its own
- K092609: Synthes 3.5 MM and 4.55 MM Curved Narrow and Broad Locking Compression Plates (LCP) (2009), 51 descendants of its own
- K120854: Synthes VA LCP Ankle Trauma System (2012), 44 descendants of its own
- K130009: Variax 2 Compression Plating System (2013), 27 descendants of its own

## Recalls of this device
- Jul 30, 2013 · Class II · Z-0409-2014: The Synthes 4.5 mm LCP Curved Condylar Plate was recalled because a Straight Condylar Plate is etched with a Curved Condylar Plate part number.

## Indications for use
The Synthes Curved Broad Plates are intended for fixation of various long bones, such as the humerus, femur, and tibia. They are also for use in fixation of peri-prosthetic fractures, osteopenic bone and non-unions or malunions. The Synthes Curved Condylar Plates are intended for buttressing multifragmentary distal femur fractures, including: supracondylar, intra-articular and extra-articular condylar fractures, peri-prosthetic fractures and fractures in normal or osteopenic bone, nonunions/malunions, and osteotomies of the femur.

Source page: https://510kreport.com/device/K041911
Methodology: https://510kreport.com/methodology
