# K092317: Deroyal Non-Sterile Locking Compression Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Deroyal Industries, Inc.
- Decided: Nov 2, 2009 after 90 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. The FDA summary names its predicate without a number.
- (no number) Synthes Locking Compression Plates (LCP): named in the summary without a submission number
- (no number) Synthes Locking Screws: named in the summary without a submission number

## Indications for use
The DeRoyal non-sterile locking compression plate system is intended for internal fixation of various bones including the clavicle, scapula, pelvis, long bones (humerus, ulna, radius, femur, tibia, and fibula), and bones of the hand and foot.

Source page: https://510kreport.com/device/K092317
Methodology: https://510kreport.com/methodology