510(k) · Cleared
ClearedMedtronic Xomed, Inc.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Xomed, Inc. · LRK Device, Anti-Snoring
Cleared on Jan 10, 2013 as substantially equivalent to K981677 (Influence, Inc., 1999) after a 156-day review. Its family tree reaches back 5 generations to 1992. 4 later devices descend from it.
- Decided
- Jan 10, 2013
- Review
- 156 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K920213 (1992). 11 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK920213 Mitek Anchor, Mitek Anchor IIMitek Surgical Products, Inc. · 1992
- 4 generations backK962372 Urotac Bone Anchor InserterInfluence, Inc. · 1996
- 3 generations backK970292 IN-Fast Bone Screw System/in-Fast Bone Screw Inserter/in-Fast Bone…Influence, Inc. · 1997 · Recalled
- 2 generations backK972023 Sleep-in Bone Screw SystemInfluence, Inc. · 1997
- 1 generation backK981677 Repose Bone Screw SystemInfluence, Inc. · 1999 · Recalled
- This deviceK122391 Medtronic Xomed, Inc.Medtronic Xomed, Inc. · 2013
- Descendant · cites it directly · 3 of its ownK133680 Encore SystemSiesta Medical, Inc. · 2014
- Descendant · cites it directly · 2 of its ownK183310 Encore SystemSiesta Medical, Inc. · 2019
- Descendant · 2 generations on · 1 of its ownK201238 Encore SystemSiesta Medical, Inc. · 2020
- Descendant · 3 generations on · 0 of its ownK213159 Encore SystemSiesta Medical, Inc. · 2021
Most influential descendants
Showing 4 of 4 · See all- K133680Encore SystemSiesta Medical, Inc. · 2014 · cites it directly3descendants
- K183310Encore SystemSiesta Medical, Inc. · 2019 · cites it directly2descendants
- K201238Encore SystemSiesta Medical, Inc. · 2020 · 2 generations on1descendant
- K213159Encore SystemSiesta Medical, Inc. · 2021 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K920213 | Mitek Anchor, Mitek Anchor II | Mitek Surgical Products, Inc. | 1992 | — |
| −4 | K962372 | Urotac Bone Anchor Inserter | Influence, Inc. | 1996 | — |
| −3 | K970292 | IN-Fast Bone Screw System/in-Fast Bone Screw Inserter/in-Fast Bone Screw | Influence, Inc. | 1997 | 1 |
| −2 | K972023 | Sleep-in Bone Screw System | Influence, Inc. | 1997 | — |
| −1 | K981677 | Repose Bone Screw System | Influence, Inc. | 1999 | 2 |
| 0 (this device) | K122391 | Medtronic Xomed, Inc. | Medtronic Xomed, Inc. | 2013 | — |
| +1 | K133680 | Encore System | Siesta Medical, Inc. | 2014 | — |
| +1 | K183310 | Encore System | Siesta Medical, Inc. | 2019 | — |
| +2 | K201238 | Encore System | Siesta Medical, Inc. | 2020 | — |
| +3 | K213159 | Encore System | Siesta Medical, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
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 LRK? 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 LRK device
- #1 K252531 Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for…score 16.3 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K981677 | Repose Bone Screw SystemSummary page 1…apnea. (21 CFR§ 872.5570) Predicate device to the AlRvance"' * ReposeT Bone Screw System Bone Screw System (K1 22391) (K981677) System Description: The AlRvanceTM Bone Screw System consists of three main components: a bone screw attached to surgi… | 1999 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 21 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
- 3 of the 11 ancestors have a recall of any class.
- Of its descendants, K133680 (Siesta Medical, Inc., 2014) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K981677.
How does its category compare?
All LRK devicesLRK Device, Anti-Snoring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · LRK
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LRK
107in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LRK
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LRK
653in 2025
MAUDE reports naming product code LRK, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 3 | 109 | 0 | 1 |
| 2009 | 3 | 88 | 2 | 11 |
| 2010 | 8 | 195 | 0 | 7 |
| 2011 | 10 | 134 | 0 | 69 |
| 2012 | 10 | 142 | 0 | 445 |
| 2013 | 9 | 233 | 0 | 72 |
| 2014 | 11 | 219 | 0 | 49 |
| 2015 | 6 | 117 | 0 | 28 |
| 2016 | 10 | 157 | 0 | 18 |
| 2017 | 7 | 170 | 0 | 32 |
| 2018 | 10 | 200 | 0 | 61 |
| 2019 | 13 | 150 | 0 | 56 |
| 2020 | 5 | 80 | 0 | 24 |
| 2021 | 10 | 126 | 0 | 49 |
| 2022 | 11 | 154 | 0 | 40 |
| 2023 | 5 | 156 | 0 | 50 |
| 2024 | 6 | 254 | 0 | 185 |
| 2025 | 14 | 107 | 1 | 653 |
| 2026 | 10 | 63 | 1 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122391 · printed Nov 5, 2026
Cite this page
510(k) Report. “K122391: Medtronic Xomed, Inc..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K122391
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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