Clavicle Fixation System
by Skeletal Dynamics, Inc. 510(k)
Active
510(k) K254288
Overview
The Clavicle Fixation System is a metallic bone fixation appliance designed for internal fixation of clavicle fractures, osteotomies, and non-unions, including those in osteopenic bone. Classified under Single/Multiple Component Metallic Bone Fixation Appliances and Accessories (21 CFR 888.3030), it provides rigid stabilization to promote proper healing of clavicular injuries.
This system is intended for use in orthopedic surgical settings and is supplied sterile for single-use. It is regulated under FDA 510(k) clearance (K254288) as substantially equivalent to a predicate device, with no third-party review. Components are metallic and intended for internal fixation, adhering to Class II regulatory standards for upper extremity implants.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK254288 | Date23 Mar 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- HRS
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3030
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Other devices from Skeletal Dynamics, Inc
Questions
What types of clavicle injuries is this fixation system designed to treat, and how does it help with healing?
The Clavicle Fixation System is specifically designed for internal fixation of clavicle fractures, osteotomies, and non-unions, including cases involving osteopenic (low bone density) bone. It provides rigid stabilization to ensure proper alignment during the healing process, which helps promote effective bone regeneration and reduces the risk of complications like displacement or malunion.
Is this system intended for reuse, or is it meant to be used only once per patient?
The Clavicle Fixation System is supplied sterile and intended for single-use only. This ensures patient safety and sterility, as it is not designed or cleared for reprocessing or reuse in clinical settings.
What materials are used in the Clavicle Fixation System, and how does that affect its use?
The system is composed entirely of metallic components, which are standard for internal bone fixation devices. The metal construction provides rigidity and strength necessary for stabilizing clavicle fractures, osteotomies, and non-unions, including in patients with weaker bone density. Metallic implants are also durable and designed to remain in place long-term as part of the healing process.
How is the Clavicle Fixation System packaged and prepared for surgical use?
The system is supplied sterile and ready for immediate use in the operating room. It is designed for orthopedic surgical settings, where surgeons can apply it directly to the clavicle after fracture reduction or osteotomy. The sterile packaging ensures it meets clinical standards for infection control before implantation.
What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its use?
The Clavicle Fixation System received FDA 510(k) clearance (K254288) under an Abbreviated pathway, determined to be substantially equivalent to a predicate device. This means the FDA reviewed it as a modification of an existing approved device rather than requiring a full pre-market approval process. The system is classified under Class II regulatory standards for upper extremity implants, indicating it has undergone FDA oversight for safety and effectiveness in its intended clinical use.