# K050110: Synthes (Usa) LCP Modular Foot Plates

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Mar 4, 2005 after 45 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 2 (0 Class I)
- 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) Modular Foot System: named in the summary without a submission number

## Most influential descendants
- K111253: Arthrex Distal Extremity Plate System (2011), 135 descendants of its own
- K112437: Arthrex Fracture System (2011), 91 descendants of its own
- K123241: Arthrex Fracture Plates (2013), 71 descendants of its own
- K141735: Arthrex Ankle Fusion Plating System (2014), 38 descendants of its own
- K140397: Paralock Plating System / Tuffnek Screw (2014), 31 descendants of its own

## Recalls of this device
- Jun 28, 2016 · Class II · Z-2389-2016: It was reported that the specified lots of the 2.4mm Titanium Locking Screw Self-Tapping with Stardrive Recess 12mm can break between the head and the shaft. This resulted from the neck feature being 
- Nov 2, 2015 · Class II · Z-0323-2016: It was discovered that the above part number and lot of 2.4mm Locking Screws may contain the incorrect package insert (GP2613, VA-LCP Distal Radius System). The correct package insert for the above pa

## Indications for use
The Synthes LCP Modular Foot Plates are intended for use in selective trauma, fractures, osteotomies, reconstructive procedures and replantations of small bones including the foot and ankle.

Source page: https://510kreport.com/device/K050110
Methodology: https://510kreport.com/methodology