# K051155: Solco 4CIS General Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Solco Biomedical Co., Ltd.
- Decided: Jul 11, 2005 after 68 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
Longest line of descent: 1 generation back to K993106 (1999). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042377: Synthes Low Profile Reconstruction Plates, Synthes (Usa) (2004) Summary page 1.
- K993106: Smith & Nephew Bone Plate System (Bone Plates, Bone Screws and Accessories), Smith & Nephew, Inc. (1999) Summary page 1.

## Indications for use
The SOLCO 4CIS® General Plate System is used for adult or pediatric patients as indicated for pelvic, small, and long bone fracture fixation. Indications for use include fractures of the tibia, fibula, femur, pelvis, metacarpals, metatarsals, humerus, ulna, radius, hand and middle foot bones.

Source page: https://510kreport.com/device/K051155
Methodology: https://510kreport.com/methodology