510(k) · Cleared
Recalled · 2009Repose Bone Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Influence, Inc. · LRK Device, Anti-Snoring
Cleared on Aug 27, 1999 as substantially equivalent to K972023 (Influence, Inc., 1997) and 2 other predicates after a 472-day review. Its family tree reaches back 4 generations to 1992. 16 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 27, 1999
- Review
- 472 days
- Class
- Class II
- Product code
- LRK
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 4 generations to K920213 (1992). 10 ancestors in all. 16 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK920213 Mitek Anchor, Mitek Anchor IIMitek Surgical Products, Inc. · 1992
- 3 generations backK962372 Urotac Bone Anchor InserterInfluence, Inc. · 1996
- 2 generations backK970292 IN-Fast Bone Screw System/in-Fast Bone Screw Inserter/in-Fast Bone…Influence, Inc. · 1997 · Recalled
- 1 generation backK972023 Sleep-in Bone Screw SystemInfluence, Inc. · 1997
- This deviceK981677 Repose Bone Screw SystemInfluence, Inc. · 1999
- Descendant · cites it directly · 5 of its ownK111549 Attune Sleep Apnea SystemApnicure, Inc. · 2012
- Descendant · cites it directly · 4 of its ownK122391 Medtronic Xomed, Inc.Medtronic Xomed, Inc. · 2013
- Descendant · cites it directly · 4 of its ownK011723 Anti-Snoring Device or AsdPi Medical · 2002
- Descendant · 2 generations on · 3 of its ownK133680 Encore SystemSiesta Medical, Inc. · 2014
- Descendant · 2 generations on · 3 of its ownK122130 Winx Sleep Therapy SystemApnicure, Inc. · 2012
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K111549Attune Sleep Apnea SystemApnicure, Inc. · 2012 · cites it directly5descendants
- K122391Medtronic Xomed, Inc.Medtronic Xomed, Inc. · 2013 · cites it directly4descendants
- K011723Anti-Snoring Device or AsdPi Medical · 2002 · cites it directly4descendants
- K133680Encore SystemSiesta Medical, Inc. · 2014 · 2 generations on3descendants
- K122130Winx Sleep Therapy SystemApnicure, Inc. · 2012 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K920213 | Mitek Anchor, Mitek Anchor II | Mitek Surgical Products, Inc. | 1992 | — |
| −3 | K962372 | Urotac Bone Anchor Inserter | Influence, Inc. | 1996 | — |
| −2 | K970292 | IN-Fast Bone Screw System/in-Fast Bone Screw Inserter/in-Fast Bone Screw | Influence, Inc. | 1997 | 1 |
| −1 | K972023 | Sleep-in Bone Screw System | Influence, Inc. | 1997 | — |
| 0 (this device) | K981677 | Repose Bone Screw System | Influence, Inc. | 1999 | — |
| +1 | K111549 | Attune Sleep Apnea System | Apnicure, Inc. | 2012 | — |
| +1 | K122391 | Medtronic Xomed, Inc. | Medtronic Xomed, Inc. | 2013 | — |
| +1 | K011723 | Anti-Snoring Device or Asd | Pi Medical | 2002 | — |
| +2 | K133680 | Encore System | Siesta Medical, Inc. | 2014 | — |
| +2 | K122130 | Winx Sleep Therapy System | Apnicure, Inc. | 2012 | — |
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 |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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? (3)
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 |
|---|---|---|---|
| * | K972023 | Sleep-in Bone Screw SystemSummary page 2…age 2 === AUG-17-33 14:57 From:HOGAN & HARTSON 7W 109 [ARARRRRRARERN T-066 P.08/10 Job-097 Predicate Devices: Repose™ Bone Screw System: e Sleep-In™ Bone Screw System (K972023) ¢ In-Fast™ Bone Screw System (K970292) e Mitek GII Anchor (K920213) Performance Standards: No performance standards applicabl… | 1997 |
| * | K970292 | IN-Fast Bone Screw System/in-Fast Bone Screw Inserter/in-Fast Bone ScrewSummary page 2…HARTSON 7W 109 [ARARRRRRARERN T-066 P.08/10 Job-097 Predicate Devices: Repose™ Bone Screw System: e Sleep-In™ Bone Screw System (K972023) ¢ In-Fast™ Bone Screw System (K970292) e Mitek GII Anchor (K920213) Performance Standards: No performance standards applicable to the bone screw systems have been es… | 1997 |
| * | K920213 | Mitek Anchor, Mitek Anchor IISummary page 2…T-066 P.08/10 Job-097 Predicate Devices: Repose™ Bone Screw System: e Sleep-In™ Bone Screw System (K972023) ¢ In-Fast™ Bone Screw System (K970292) e Mitek GII Anchor (K920213) Performance Standards: No performance standards applicable to the bone screw systems have been established by the FDA. However… | 1992 |
What descends from it? (16)
See all 163 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 27, 2009 | Not classified | Z-0535-2010 | Labeling mix-ups | Medtronic Xomed, Inc. is recalling the Repose Bone Screw System product and Bone Screw product due to improper labeling. The labeling for the Repose System was inadvertently placed on the Repose Screw and vice versa. |
| Jul 27, 2009 | Not classified | Z-0536-2010 | Labeling mix-ups | Medtronic Xomed, Inc. is recalling the Repose Bone Screw System product and Bone Screw product due to improper labeling. The labeling for the Repose System was inadvertently placed on the Repose Screw and vice versa. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 2.0 years on median.
- 2 of the 10 ancestors have a recall of any class.
- Of its descendants, K111549 (Apnicure, Inc., 2012) has gone furthest, with 5 descendants of its own.
- 2 other devices also cite its predicate K972023.
How does its category compare?
All LRK devicesLRK Device, Anti-Snoring: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Repose™ 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 also suitable for the performance of a hyoid suspension procedure as an adjunct to tongue base suspension. It is indicated for the treatment of obstructive sleep apnea (“OSA”) and/or snoring.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981677 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981677: Repose Bone Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981677
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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