# K090975: Deroyal Non-Locking Bone Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Deroyal Industries, Inc.
- Decided: Apr 12, 2010 after 371 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The DeRoyal Non-Locking Bone Fixation System components are provided non-sterile. The system is intended to treat fractures of various bones, including the clavicle, scapula, long bones, (humerus, ulna, radius, femur, tibia and fibula), small bones (metacarpals, metatarsals, and phalanges). A Screw-Plate Usage Chart is included to assist the user in selection of the appropriate screws for recommended use with each plate. Cannulated screws included in this bone fixation system are not designed to be used with specific plates. They can be used as a stand alone fracture fixation; or in the case of compromised bone stock, they can be used in conjunction with washers. The washer components are intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces I load over a larger area when used for fracture fixation of large (long) bone and bone fragments. Additionally, the washers are intended to prevent the projection of the screw head when the screw must be inserted at an acute angle such as in ankle arthrodesis. The wires in this system are for use in the fixation of bone fractures, for bone reconstruction or as a guide for insertion of other medical devices.

Source page: https://510kreport.com/device/K090975
Methodology: https://510kreport.com/methodology