# K252758: Cannulated Screw and Kirschner (K wire) System

- Pathway: 510(k) (Special)
- Applicant: Orthonovis, Inc.
- Decided: Oct 2, 2025 after 34 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K000684 (2000). 103 ancestors in all.
No later device cites it as a predicate yet.
0 of 104 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130613: Cannulated Screw and Kirschner (Kwire) System, Laura Cattabriga (2014) Summary page 5.
- K250055: BPS - Bone Fragment Fixation Plates, Screws and Washers, Orthonovis, Inc. (2025) Summary page 5.
- K231504: TITANEX™ MICROBEAM Screw System, TITANEX™ ARTEMIS Screw System, Vilex, LLC (2023) Summary page 5.

## Indications for use
The Intended Use of the Cannulated Screw and Kirschner (Kwire) System is for the treatment and fixation of bone fractures and osteotomies of various bones including the clavicle, acetabulum, pelvis, scapula, humerus, radius, ulna, femur, tibia, phalanges, carpals, metacarpals, tarsals, metatarsals and fibula.

Source page: https://510kreport.com/device/K252758
Methodology: https://510kreport.com/methodology