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FDA 510(k)

Cannulated Screw and Kirschner (K wire) System

K-Number: K252758 · 2025-10-02

ApplicantOrthonovis, Inc.
Decision Date2025-10-02
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Cannulated Screw and Kirschner (K wire) System is a medical device manufactured by Orthonovis, Inc.. It received FDA 510(k) clearance on 2025-10-02 under approval number K252758. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cannulated Screw and Kirschner (K wire) System?

Cannulated Screw and Kirschner (K wire) System is a medical device that received FDA 510(k) clearance on 2025-10-02. It is manufactured by Orthonovis, Inc.. The 510(k) number is K252758.

When was Cannulated Screw and Kirschner (K wire) System approved by the FDA?

Cannulated Screw and Kirschner (K wire) System received FDA 510(k) clearance on 2025-10-02, under approval number K252758.

What company makes Cannulated Screw and Kirschner (K wire) System?

Cannulated Screw and Kirschner (K wire) System is manufactured by Orthonovis, Inc..

What is the FDA product code for Cannulated Screw and Kirschner (K wire) System?

The FDA product code for Cannulated Screw and Kirschner (K wire) System is HWC. This falls under the Cardiovascular category.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT05565131 Performance Measurement and Safety Evaluation of the PYTHEAS® ODYSSEE Angular Assistance System for Intra-pedicular Screw Placement in Adult Spine Surgery COMPLETED NCT06720948 The ION Facet Screw System Ambispective Evaluation ENROLLING_BY_INVITATION NCT06960018 Clinical Study on the Safety and Efficacy of the Minimally Invasive Ennovate® Method for Pedicle Screw Placement RECRUITING

Related PubMed Literature

PMID: 38493931 Establishing finite element model credibility of a pedicle screw system under compression-bending: An end-to-end example of the ASME V&V 40 standard. Methods (San Diego, Calif.) (2024) PMID: 37209414 Adverse events associated with Aveir Journal of cardiovascular electrophysiology (2023) PMID: 30035086 Translational research of one dynamic hip screw system-from the SCI to the FDA. Journal of orthopaedic translation (2016)

Other Devices by Orthonovis, Inc.

K213905ONX Large External Fixation System K242343BPS Wrist Fracture System K250498BPS Wrist Fracture System K250055BPS - Bone Fragment Fixation Plates, Screws and Washers

Related Devices (Code: HWC)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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