510(k) · Cleared
ClearedPillar Palatal Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Restore Medical, Inc. · LRK Device, Anti-Snoring
Cleared on Jul 28, 2004 as substantially equivalent to K011723 (Pi Medical, 2002) and 2 other predicates after a 161-day review. Its family tree reaches back 6 generations to 1992.
- Decided
- Jul 28, 2004
- Review
- 161 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K920213 (1992). 14 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK920213 Mitek Anchor, Mitek Anchor IIMitek Surgical Products, Inc. · 1992
- 5 generations backK962372 Urotac Bone Anchor InserterInfluence, Inc. · 1996
- 4 generations backK970292 IN-Fast Bone Screw System/in-Fast Bone Screw Inserter/in-Fast Bone…Influence, Inc. · 1997 · Recalled
- 3 generations backK972023 Sleep-in Bone Screw SystemInfluence, Inc. · 1997
- 2 generations backK981677 Repose Bone Screw SystemInfluence, Inc. · 1999 · Recalled
- 1 generation backK011723 Anti-Snoring Device or AsdPi Medical · 2002
- This deviceK040417 Pillar Palatal Implant SystemRestore Medical, Inc. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K920213 | Mitek Anchor, Mitek Anchor II | Mitek Surgical Products, Inc. | 1992 | — |
| −5 | K962372 | Urotac Bone Anchor Inserter | Influence, Inc. | 1996 | — |
| −4 | K970292 | IN-Fast Bone Screw System/in-Fast Bone Screw Inserter/in-Fast Bone Screw | Influence, Inc. | 1997 | 1 |
| −3 | K972023 | Sleep-in Bone Screw System | Influence, Inc. | 1997 | — |
| −2 | K981677 | Repose Bone Screw System | Influence, Inc. | 1999 | 2 |
| −1 | K011723 | Anti-Snoring Device or Asd | Pi Medical | 2002 | — |
| 0 (this device) | K040417 | Pillar Palatal Implant System | Restore Medical, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 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 |
|---|---|---|---|
| * | K011723 | Anti-Snoring Device or AsdSummary page 1…lant System ( a/k/a Anti-Snoring Device), manufactured by Restore Medical Inc, and cleared via 5 10(k) Notification K01 1723 on December 18, 2002 for the treatment of snoring. Somnoplasty System, man… | 2002 |
| * | K982717 | Somnoplasty System, Models S2, 1010/2010,2000/1000,1100,3000/30XX/6000, 1200Summary page 1…System, manufactured by Gyrus PLC (formerly Somnus Medical Technologies, Inc.) and cleared via 510(k) Notification K982717 on November 2, 1998 for the reduction of the incidence of airway obstructions in patients suffering fr… | 1998 |
| * | K972023 | Sleep-in Bone Screw SystemSummary page 1…leep Apnea Syndrome). Sleep-In Bone Screw System, manufactured by Influence, Inc. cleared via 5 10(k) Notification K972023 on August 25, 1997 for the treatment of obstructive sleep apnea and/or snoring.… | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
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 12 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
- 3 of the 14 ancestors have a recall of any class.
- 1 other device also cites its predicate K011723.
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 PillarTM Palatal Implant System is intended for the reduction of the incidence of airway obstructions in patients suffering from mild to moderate OSA (Obstructive Sleep Apnea).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040417 · printed Nov 5, 2026
Cite this page
510(k) Report. “K040417: Pillar Palatal Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K040417
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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