# K042355: Synthes (Usa) LCP Wrist Fusion Plates

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Oct 27, 2004 after 57 days
- Product code: HRS (Plate, Fixation, Bone)
- 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.
24 later devices descend from it; 11 cite it directly.
0 of 25 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 Straight Wrist Fusion Plate, 170 mm: named in the summary without a submission number

## Most influential descendants
- K112169: Aptus Wrist Arthrodesis Plates (2012), 8 descendants of its own
- K192297: APTUS Wrist Arthrodesis Plates (2019), 7 descendants of its own
- K223853: Medartis APTUS® Ulna Plates (2023), 5 descendants of its own
- K234062: APTUS Hand Scaphoid Plates (2024), 3 descendants of its own
- K232144: Sterile Products of the APTUS System (2023), 3 descendants of its own

## Indications for use
Synthes (USA) LCP Wrist Fusion Plates are intended for wrist arthrodesis and fractures of other small bones. Specific indications include post-traumatic arthritis of the joints of the wrist; rheumatoid wrist deformities requiring restoration; complex carpal instability; post-septic arthritis of the wrist; severe unremitting wrist pain related to motion; brachial plexus nerve palsies; tumor resection; and spastic deformities.

Source page: https://510kreport.com/device/K042355
Methodology: https://510kreport.com/methodology