# K103179: Prelude II Tounge Suspension System

- Pathway: 510(k) (Special)
- Applicant: Siesta Medical, Inc.
- Decided: Dec 20, 2010 after 53 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: 5 generations back to K920213 (1992). 11 ancestors in all.
14 later devices descend from it; 1 cites it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101060: Siesta Medical, Inc., Prelude Tongue Suspension System, Siesta Medical, Inc. (2010) Summary page 1.

## Most influential descendants
- K110127: Prelude Iii Tongue Suspension System (2011), 13 descendants of its own
- K111179: Encore Tongue Suspension System (Monofilament #1 Suspension Suture), Encore Tongue Suspension System System (Monofilamen (2011), 6 descendants of its own
- K111549: Attune Sleep Apnea System (2012), 5 descendants of its own
- K121440: Encore Tongue Suspension System Encore Removal-Titration Kit (2012), 4 descendants of its own
- K133680: Encore System (2014), 3 descendants of its own

## Indications for use
The Siesta Medical, Inc. PRELUDE 11 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 for snoring.

Source page: https://510kreport.com/device/K103179
Methodology: https://510kreport.com/methodology