# K241599: Signature Osteosynthesis Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Signature Orthopaedic Pty, Ltd.
- Decided: Feb 6, 2025 after 247 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: 15 generations back to K962616 (1996). 142 ancestors in all.
No later device cites it as a predicate yet.
0 of 143 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171320: ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS Humerus and Olecranon Plates & MBOSS/FIXION Screws, ARMAR / ARTIS Tibia and Buttress Plates & MBOSS/FIXION Screws, ARMAR / ARTIS 2.4mm Plates & MBOSS/FIXION Screws, ARMAR/ ARTISClavical Hook Plate & MBOSS/FIXION Screws, ARMAR/ ARTIS Metaphyseal Plate & MBOSS/FIXION Screws, ARMAR / ARTISCalcaneal Plate & MBOSS/FIXION Screws, Meril Healthcare Pvt., Ltd. (2018) Summary page 5.

## Indications for use
The Signature Osteosynthesis Plate System is intended for adult patients for internal fixation and stabilization of fractures, osteotomies, malunions, and non-unions. The 1/3 Tubular Plate and Compression Plate Small are intended for internal fixation and stabilization of fractures, osteotomies, malunions, and non-unions of the Foot, hand, wrist, and forearm. Additionally, the Compression Plate Narrow and Compression Plate Broad are intended for internal fixation and stabilization of fractures, osteotomies, malunions, and non-unions of the upper extremity and lower extremity, except for the femur and proximal tibia. The Clavicle Plates are intended for use in fixation of fractures, osteotomies, and non-unions of the clavicle in adult patients in whom the clavicular growth plates have fused or in whom the growth plates can be crossed by the plate system.

Source page: https://510kreport.com/device/K241599
Methodology: https://510kreport.com/methodology