# K122391: Medtronic Xomed, Inc.

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Xomed, Inc.
- Decided: Jan 10, 2013 after 156 days
- Product code: LRK (Device, Anti-Snoring)
- Device class: 2
- Regulation: 21 CFR 872.5570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K920213 (1992). 11 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981677: Repose Bone Screw System, Influence, Inc. (1999) Summary page 1.

## Most influential descendants
- K133680: Encore System (2014), 3 descendants of its own
- K183310: Encore System (2019), 2 descendants of its own
- K201238: Encore System (2020), 1 descendant of its own
- K213159: Encore System (2021), 0 descendants of its own

## Indications for use
The AIRvance Bone Screw System is intended for anterior tongue base suspension by fixation of the soft tissue of the tongue base to the mandible bone using a bone screw with pre-threaded suture. It is indicated for the treatment of obstructive sleep apnea (OSA) and/or snoring. The AIRvance Bone Screw System is also suitable for the performance of a hyoid suspension procedure which can be used in combination with other procedures for the treatment of obstructive sleep apnea (OSA). It is indicated for the treatment of obstructive sleep apnea (OSA) and/or snoring.

Source page: https://510kreport.com/device/K122391
Methodology: https://510kreport.com/methodology