Akro Vu Videoscopic Carpal Tunnel Release (VCTR) System
by Skeletal Dynamics, LLC 510(k)
Active
510(k) K092723
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK092723 | Date4 Oct 2010 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- 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
- HRX
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.1100
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Akro Vu Videoscopic Carpal Tunnel Release (VCTR) System is a battery-powered, stand-alone surgical platform designed for minimally invasive carpal tunnel release procedures. It integrates a reusable video monitor, sterile enclosure, and disposable video-blades that combine a camera, light source, and deployable cutting mechanism to enhance visualization and precision during surgery.
The system is supplied as a reusable surgical platform with single-use disposable video-blades, intended for use in an operating room setting. It has been granted FDA 510(k) clearance under the Orthopedic advisory committee, classified under product code HRX and regulation 888.1100. The device is not MRI-safe and requires proper storage of reusable components and sterile handling of disposable blades.
Other devices from Skeletal Dynamics, Inc
Questions
AI-generated answers, 19 Sep 2026
What types of surgical procedures is the Akro Vu Videoscopic Carpal Tunnel Release (VCTR) System designed for?
The Akro Vu VCTR System is specifically designed for minimally invasive carpal tunnel release procedures. It combines a video monitor, sterile enclosure, and disposable video-blades to provide enhanced visualization and precision during surgery, making it ideal for this orthopedic application.
How is the Akro Vu VCTR System supplied, and what components are reusable versus disposable?
The system is supplied as a reusable surgical platform, which includes the video monitor and sterile enclosure. However, the video-blades—integrating a camera, light source, and cutting mechanism—are single-use disposables. This design ensures sterility and precision for each procedure.
Are the reusable components of the Akro Vu VCTR System compatible with MRI environments?
No, the reusable components of the Akro Vu VCTR System are not MRI-safe. This means they should not be used or stored in an MRI environment, as exposure could pose risks to the device or interfere with imaging.
What special handling or storage requirements apply to the reusable parts of the system?
The reusable components of the Akro Vu VCTR System require proper storage to maintain functionality and sterility. Since they are part of a surgical platform, they should be cleaned, disinfected, and stored according to manufacturer guidelines to prevent contamination and ensure readiness for future procedures.
How is the system’s regulatory clearance categorized, and what does that mean for its use?
The Akro Vu VCTR System received FDA 510(k) clearance under the Orthopedic advisory committee, classified under product code HRX and regulation 888.1100. This means it has been determined to be substantially equivalent to a legally marketed device, allowing it to be legally marketed and used in the U.S. for its intended purpose—minimally invasive carpal tunnel release—following the manufacturer’s instructions.