# K033805: Synthes (Usa) 3.5 / 4.5 MM LCP Metaphyseal Plates

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Feb 20, 2004 after 74 days
- Product code: LXT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite)
- 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.
142 later devices descend from it; 7 cite it directly.
0 of 143 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 (USA) Small Fragment DCL System: named in the summary without a submission number
- (no number) Synthes (USA) Large Fragment DCL System: named in the summary without a submission number

## Most influential descendants
- K103332: Aptus Ulna Plates (2011), 71 descendants of its own
- K142906: APTUS Wrist 2.5 System (2015), 59 descendants of its own
- K120854: Synthes VA LCP Ankle Trauma System (2012), 44 descendants of its own
- K042598: Periarticular Locking Plates and Screws, 2357 and 2359 Series (2004), 31 descendants of its own
- K050121: Zimmer Periarticular Locking Plate System, Model 2357 & 2359 (2005), 27 descendants of its own

## Indications for use
The Synthes (USA) 3.5 /4.5mm LCP® Metaphyseal Plate is intended for the fixation of various long bones, excluding the femur. It is also for use in fixation of osteopenic bone and fixation of nonunions or malunions.

Source page: https://510kreport.com/device/K033805
Methodology: https://510kreport.com/methodology