# K121814: Encore Tongue Suspension System

- Pathway: 510(k) (Traditional)
- Applicant: Siesta Medical, Inc.
- Decided: Nov 7, 2012 after 140 days
- Product code: ORY (Tongue Suspension System)
- 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: 8 generations back to K920213 (1992). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111179: Encore Tongue Suspension System (Monofilament #1 Suspension Suture), Encore Tongue Suspension System System (Monofilamen, Siesta Medical, Inc. (2011)

## Indications for use
The Siesta Medical Inc. ENCORE Tongue Suspension System is intended to be used for anterior advancement of the tongue base by means of a bone screw threaded with suture. It is indicated for the treatment of mild or moderate obstructive sleep apnea (OSA) and /or snoring.

Source page: https://510kreport.com/device/K121814
Methodology: https://510kreport.com/methodology