Sidekick EZ Frame External Fixation System
by Wrightmedicaltechnologyinc 510(k)
Active
510(k) K130044
Overview
The Sidekick EZ Frame External Fixation System is a mechanical orthopedic device classified as an external fixation device. It is designed to stabilize bone fractures, particularly in the foot and lower limb, by applying controlled compression or distraction via pins and wires. The modular construction allows for customizable configurations to match patient anatomy, ensuring precise alignment and support during the healing process.
This system is supplied as a reusable medical device and is intended for use in orthopedic surgical settings. It includes a boot component for securing the tibia and is adjustable to accommodate anatomical variations. The device has received FDA 510(k) clearance under the Traditional review pathway, with the advisory committee classification under Orthopedics. No specific sterility or MRI safety information is provided in the available data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK130044 | Date5 Apr 2013 | 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- Withdrawn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
- KTT
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3030
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Other devices from Wrightmedicaltechnologyinc
Questions
Is the Sidekick EZ Frame External Fixation System designed for single-use or can it be reused in multiple procedures?
The Sidekick EZ Frame External Fixation System is explicitly described as a reusable medical device. This means it is intended for use across multiple patients or procedures in an orthopedic surgical setting, provided proper cleaning, maintenance, and sterilization protocols are followed between uses.
What anatomical areas is this external fixation system primarily intended to stabilize, and how does its modular design help?
The Sidekick EZ Frame is primarily designed to stabilize bone fractures in the foot and lower limb, including the tibia. Its modular construction allows clinicians to customize the configuration to match individual patient anatomy, ensuring precise alignment and support during the healing process.
How is the device secured to the patient, and what adjustments can be made to accommodate different patients?
The system includes a boot component specifically designed to secure the tibia, providing stability. It is adjustable to accommodate anatomical variations, ensuring a tailored fit for different patients while maintaining proper alignment and compression/distraction for fracture healing.
What type of regulatory review pathway was followed for FDA clearance of this device, and what does that mean for its use?
The Sidekick EZ Frame received FDA 510(k) clearance under the Traditional review pathway, meaning its safety and effectiveness were compared to a legally marketed predicate device. This clearance confirms the device meets regulatory standards for use in orthopedic surgical settings as described, though clinical application should still follow established medical guidelines.
Does the device come with any specific sterility guarantees or MRI safety information provided by the manufacturer?
The available data does not include explicit details about sterility guarantees or MRI safety for the Sidekick EZ Frame. Clinicians should verify compatibility with MRI environments and follow standard sterilization protocols if reuse is intended, as the device is not labeled as sterile or MRI-safe in the provided information.