# K040588: Synthes (Usa) 2.4 MM LCP Wrist Plate

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: May 7, 2004 after 63 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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) Biomet® Colles Fracture Plate: named in the summary without a submission number

## Most influential descendants
- K192327: DePuy Synthes 2.4mm LCP Straight Wrist Plate, Sterile (2019), 0 descendants of its own

## Recalls of this device
- 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 (USA) 2.4mm LCP Wrist Plate is intended for colles' and distal radius fractures with dorsal angulation of the distal fragment.

Source page: https://510kreport.com/device/K040588
Methodology: https://510kreport.com/methodology