# K192873: SX-One MicroKnife

- Pathway: 510(k) (Traditional)
- Applicant: Sonex Health, Inc.
- Decided: Dec 20, 2019 after 73 days
- Product code: LXH (Orthopedic Manual Surgical Instrument)
- Device class: 1
- Regulation: 21 CFR 888.4540
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K943873 (1995). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943873: Orthomet Anatomically Guided Carpal Tunnel Release SY, Orthomet, Inc. (1995) Summary page 4.

## Most influential descendants
- K252594: UltraGuideCTR® image guided soft tissue release system (2025), 0 descendants of its own

## Recalls of this device
- Jun 29, 2022 · Class II · Z-1387-2022: Potential of dull blade

## Indications for use
The SX-One MicroKnife is a disposable device intended to create space within the carpal tunnel and transect the transverse carpal ligament (TCL) for the treatment of carpal tunnel syndrome.

Source page: https://510kreport.com/device/K192873
Methodology: https://510kreport.com/methodology