# K092723: Akro VU Videoscopic Carpal Tunnel Release (VCTR) System

- Pathway: 510(k) (Traditional)
- Applicant: Skeletal Dynamics, LLC
- Decided: Oct 4, 2010 after 395 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K912871 (1991). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K912871: Inside Job, 3M Health Care, Ltd. (1991) Summary page 2.

## Indications for use
The Akro-Vu Videoscopic Carnal Tunnel Release System (VCTR) is for use in patients diagnosed with carpal tunnel syndrome that is not associated with, or secondary to, any other known pathology (i.e. idiopathic carpal tunnel syndrome). Preoperative x-rays of the wrist, including a carnal tunnel view, are recommended to aid in the diagnosis of associated pathology (i.e. calcific tendonitis, fracture of the hook of the hamate). This device is indicated solely for releasing the flexor retinaculumn (transverse carnal ligament). Contraindications: The device is not intended for use in patients with known abnormalities of their wrist (carnal tunnel), including distal radial deformities, rheumatoid and other synovitis.

Source page: https://510kreport.com/device/K092723
Methodology: https://510kreport.com/methodology