510(k) Report

510(k) · Cleared

Cleared

Encore Tongue Suspension System (Monofilament #1 Suspension Suture), Encore Tongue Suspension System System (Monofilamen

K111179510(k) SpecialCleared Jul 1, 201165-day reviewClass II21 CFR 872.5570

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Siesta Medical, Inc. · ORY Tongue Suspension System

Cleared on Jul 1, 2011 as substantially equivalent to K110127 (Siesta Medical, Inc., 2011) after a 65-day review. Its family tree reaches back 7 generations to 1992. 6 later devices descend from it.

Decided
Jul 1, 2011
Review
65 days
Class
Class II
Product code
ORY
Recalls
None
Predicates
1

Its longest line of descent runs back 7 generations to K920213 (1992). 13 ancestors in all. 6 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1996: 2 other ancestors1995: 3 other ancestors1994: 1 other ancestor2012: 2 descendants cleared2014: 1 descendant cleared2019: 1 descendant cleared2020: 1 descendant cleared2021: 1 descendant clearedK920213 · Mitek Anchor, Mitek Anchor II · Mitek Surgical Products, Inc. · 1992K962372 · Urotac Bone Anchor Inserter · Influence, Inc. · 1996×2: 2 generations cleared close together, K970292 (1997), K972023 (1997) K101060 · Siesta Medical, Inc., Prelude Tongue Suspension System · Siesta Medical, Inc. · 2010×2: 2 generations cleared close together, K103179 (2010), K110127 (2011) 1990200020102020
Other ancestors, by generationDescendants, by generation 5 generations back: 3 other ancestors6 generations back: 3 other ancestors 1 generation forward: 2 descendants2 generations forward: 1 descendant3 generations forward: 1 descendant4 generations forward: 1 descendant5 generations forward: 1 descendant K110127 · Prelude Iii Tongue Suspension System · Siesta Medical, Inc. · 2011K103179 · Prelude II Tounge Suspension System · Siesta Medical, Inc. · 2010K101060 · Siesta Medical, Inc., Prelude Tongue Suspension System · Siesta Medical, Inc. · 2010K972023 · Sleep-in Bone Screw System · Influence, Inc. · 1997K970292 · IN-Fast Bone Screw System/in-Fast Bone Screw Inserter/in-Fast Bone Screw · Influence, Inc. · 1997 · recalledK962372 · Urotac Bone Anchor Inserter · Influence, Inc. · 1996K920213 · Mitek Anchor, Mitek Anchor II · Mitek Surgical Products, Inc. · 1992−50+5
  1. Root · 7 generations backK920213 Mitek Anchor, Mitek Anchor IIMitek Surgical Products, Inc. · 1992
  2. 6 generations backK962372 Urotac Bone Anchor InserterInfluence, Inc. · 1996
  3. 5 generations backK970292 IN-Fast Bone Screw System/in-Fast Bone Screw Inserter/in-Fast Bone…Influence, Inc. · 1997 · Recalled
  4. 4 generations backK972023 Sleep-in Bone Screw SystemInfluence, Inc. · 1997
  5. 3 generations backK101060 Siesta Medical, Inc., Prelude Tongue Suspension SystemSiesta Medical, Inc. · 2010
  6. 2 generations backK103179 Prelude II Tounge Suspension SystemSiesta Medical, Inc. · 2010
  7. 1 generation backK110127 Prelude Iii Tongue Suspension SystemSiesta Medical, Inc. · 2011
  8. This deviceK111179 Encore Tongue Suspension System (Monofilament #1 Suspension Suture)…Siesta Medical, Inc. · 2011
  9. Descendant · cites it directly · 4 of its ownK121440 Encore Tongue Suspension System Encore Removal-Titration KitSiesta Medical, Inc. · 2012
  10. Descendant · 2 generations on · 3 of its ownK133680 Encore SystemSiesta Medical, Inc. · 2014
  11. Descendant · 3 generations on · 2 of its ownK183310 Encore SystemSiesta Medical, Inc. · 2019
  12. Descendant · 4 generations on · 1 of its ownK201238 Encore SystemSiesta Medical, Inc. · 2020
  13. Descendant · 5 generations on · 0 of its ownK213159 Encore SystemSiesta Medical, Inc. · 2021

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2012: 22014: 12019: 12020: 12021: 1
2012high 2 (2012) · low 0 (2013)2026

Most influential descendants

Showing 5 of 6 · See all
  • K121440Encore Tongue Suspension System Encore Removal-Titration KitSiesta Medical, Inc. · 2012 · cites it directly4descendants
  • K133680Encore SystemSiesta Medical, Inc. · 2014 · 2 generations on3descendants
  • K183310Encore SystemSiesta Medical, Inc. · 2019 · 3 generations on2descendants
  • K201238Encore SystemSiesta Medical, Inc. · 2020 · 4 generations on1descendant
  • K213159Encore SystemSiesta Medical, Inc. · 2021 · 5 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K920213Mitek Anchor, Mitek Anchor IIMitek Surgical Products, Inc.1992—
−6K962372Urotac Bone Anchor InserterInfluence, Inc.1996—
−5K970292IN-Fast Bone Screw System/in-Fast Bone Screw Inserter/in-Fast Bone ScrewInfluence, Inc.19971
−4K972023Sleep-in Bone Screw SystemInfluence, Inc.1997—
−3K101060Siesta Medical, Inc., Prelude Tongue Suspension SystemSiesta Medical, Inc.2010—
−2K103179Prelude II Tounge Suspension SystemSiesta Medical, Inc.2010—
−1K110127Prelude Iii Tongue Suspension SystemSiesta Medical, Inc.2011—
0 (this device)K111179Encore Tongue Suspension System (Monofilament #1 Suspension Suture), Encore…Siesta Medical, Inc.2011—
+1K121440Encore Tongue Suspension System Encore Removal-Titration KitSiesta Medical, Inc.2012—
+2K133680Encore SystemSiesta Medical, Inc.2014—
+3K183310Encore SystemSiesta Medical, Inc.2019—
+4K201238Encore SystemSiesta Medical, Inc.2020—
+5K213159Encore SystemSiesta Medical, Inc.2021—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199530
199620

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201220
201410
201910
202010
202110
FIG. 1 — Lineage of K111179, 1992–2021Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in ORY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new ORY device

  1. #1 K201238 Encore Systemscore 6.1 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K110127Prelude Iii Tongue Suspension SystemSiesta Medical, Inc.2011—

Also cleared against K110127: 1 other device →

What descends from it? (6)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K121440Encore Tongue Suspension System Encore Removal-Titration KitSiesta Medical, Inc.20124
K121814Encore Tongue Suspension SystemSiesta Medical, Inc.20120

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 5 months on median.
  • 2 of the 13 ancestors have a recall of any class.
  • Of its descendants, K121440 (Siesta Medical, Inc., 2012) has gone furthest, with 4 descendants of its own.
  • 1 other device also cites its predicate K110127.

How does its category compare?

All ORY devices

ORY Tongue Suspension System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · ORY

1in 2021

2010: 22011: 22012: 22014: 12019: 12020: 12021: 1
2007high 2 (2010) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ORY

Too few ORY 510(k)s in any year since 2007 to give a median.

Recalls per year · ORY

No recall names ORY since 2007.

Adverse event reports per year · ORY

5in 2025

2014: 92015: 12018: 22019: 22020: 22022: 22023: 202024: 112025: 5
2007high 20 (2023) · low 0 (2007)2025

MAUDE reports naming product code ORY, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20102—00
20112—00
20122—00
20130—00
20141—09
20150—01
20160—00
20170—00
20180—02
20191—02
20201—02
20211—00
20220—02
20230—020
20240—011
20250—05
20260—0—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

Also cleared against K110127

1 other device cites the same predicate.

  • K111549Attune Sleep Apnea SystemApnicure, Inc. · 2012

More from Siesta Medical, Inc.

10 FDA decisions under this applicant name. See the company

  • K213159Encore SystemSiesta Medical, Inc. · 2021
  • K201238Encore SystemSiesta Medical, Inc. · 2020
  • K183310Encore SystemSiesta Medical, Inc. · 2019
  • K133680Encore SystemSiesta Medical, Inc. · 2014
  • K121440Encore Tongue Suspension System Encore Removal-Titration KitSiesta Medical, Inc. · 2012

Recent decisions in ORY

The ORY category page

  • K213159Encore SystemSiesta Medical, Inc. · 2021
  • K201238Encore SystemSiesta Medical, Inc. · 2020
  • K183310Encore SystemSiesta Medical, Inc. · 2019
  • K133680Encore SystemSiesta Medical, Inc. · 2014
  • K121440Encore Tongue Suspension System Encore Removal-Titration KitSiesta Medical, Inc. · 2012

https://510kreport.com/device/K111179 · printed Nov 6, 2026

Cite this page

510(k) Report. “K111179: Encore Tongue Suspension System (Monofilament #1 Suspension Suture), Encore Tongue Suspension System System (Monofilamen.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111179

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026