SteriTrak
by Arbutus Medical, Inc. Canada 510(k)
510(k) K203605
Product code JEC
Overview
The SteriTrak is a Component, Traction, Invasive device designed for skeletal traction applications. It is intended for implantation through the skin and bone to apply traction to the skeletal system, aiding in orthopedic stabilization and alignment during trauma or surgical interventions. This device falls under the FDA’s Orthopedic specialty classification and is classified as a Class II medical device under regulation 888.3040.
SteriTrak is supplied as a sterile, single-use kit for use in trauma centers, hospital emergency departments, and orthopedic surgical settings. The device is intended for invasive procedures and must be handled under aseptic conditions. It is authorized for use in the U.S. and Canada following FDA 510(k) clearance under the Traditional review pathway. No MRI safety information is specified, and storage conditions are not detailed in the regulatory submission.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK203605 | Date23 Apr 2021 | StatusActive |
Coverage
- Active
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- JEC
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3040
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Other devices from Arbutus Medical, Inc.
Questions
What is the SteriTrak device used for?
The SteriTrak is designed for skeletal traction applications, intended to be implanted through the skin and bone to apply traction to the skeletal system. This helps in orthopedic stabilization and alignment during trauma or surgical interventions, ensuring proper positioning and support for healing.
How is the SteriTrak supplied and where can it be used?
SteriTrak is supplied as a sterile, single-use kit. It is intended for use in trauma centers, hospital emergency departments, and orthopedic surgical settings. Due to its invasive nature, it must be handled under aseptic conditions to maintain sterility and patient safety.
Is the SteriTrak device reusable or single-use?
The SteriTrak is explicitly supplied as a single-use device. This design ensures patient safety by preventing cross-contamination and maintaining sterility for each procedure, which is critical for invasive medical applications.
What regulatory approvals does the SteriTrak have?
The SteriTrak has received FDA 510(k) clearance under the Traditional review pathway, authorizing its use in the U.S. and Canada. It is classified as a Class II medical device under regulation 888.3040, indicating it has been deemed substantially equivalent to a predicate device.
Are there any specific storage instructions for the SteriTrak?
The regulatory submission for the SteriTrak does not provide detailed storage conditions. Clinicians should follow standard sterile supply chain protocols to ensure the device remains uncontaminated until use, particularly given its single-use nature and invasive application.
Properties & raw data
Show properties, registry sources and raw records
Sources (1)
- FDA 510(k) K203605