510(k) · Cleared
ClearedComposite Removable Sinus Stent System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sts Medical · LYA Splint, Intranasal Septal
Cleared on Dec 15, 2017 as substantially equivalent to K092401 (Sinexus, Inc., 2009) after a 262-day review. Its family tree reaches back 5 generations to 1997.
- Decided
- Dec 15, 2017
- Review
- 262 days
- Class
- Class I
- Product code
- LYA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K972082 (1997). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK972082 Custom Nasal SplintBoston Medical Products, Inc. · 1997
- 4 generations backK012532 Sepragel SinusGenzyme Corp. · 2001
- 3 generations backK063308 Advacoat Sinus Gel, Model 9100, Adva Sinus Stent, Model 9200Carbylan Biosurgery · 2006
- 2 generations backK070496 Advacoat Sinus Gel and StentCarbylan Biosurgery · 2007
- 1 generation backK092401 Sinexus Sinus Stent Gen 2, Model 1999-25Sinexus, Inc. · 2009
- This deviceK170913 Composite Removable Sinus Stent SystemSts Medical · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K972082 | Custom Nasal Splint | Boston Medical Products, Inc. | 1997 | — |
| −4 | K012532 | Sepragel Sinus | Genzyme Corp. | 2001 | — |
| −3 | K063308 | Advacoat Sinus Gel, Model 9100, Adva Sinus Stent, Model 9200 | Carbylan Biosurgery | 2006 | — |
| −2 | K070496 | Advacoat Sinus Gel and Stent | Carbylan Biosurgery | 2007 | — |
| −1 | K092401 | Sinexus Sinus Stent Gen 2, Model 1999-25 | Sinexus, Inc. | 2009 | — |
| 0 (this device) | K170913 | Composite Removable Sinus Stent System | Sts Medical | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 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 LYA? 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 LYA device
- #1 K243655 TurbAlignscore 10.0 · 2 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 |
|---|---|---|---|
| * | K092401 | Sinexus Sinus Stent Gen 2, Model 1999-25Summary page 4…and Throat Surgical Device, Intranasal splint Regulatory Class I Product code: LYA Predicate Device: K092401 Sinus Stent, product code LYA The intended use of the device is similar to the… | 2009 |
| † | K120280 | Relieva Seeker Balloon Sinuplasty System | 2012 |
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 20 years and passes through 5 companies; a new generation was cleared every 4.3 years on median.
- None of the 10 ancestors has a recall.
How does its category compare?
All LYA devicesLYA Splint, Intranasal Septal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · LYA
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LYA
104in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LYA
No recall names LYA since 2007.
Adverse event reports per year · LYA
1in 2025
MAUDE reports naming product code LYA, 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 | 2 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 5 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 16 |
| 2012 | 1 | — | 0 | 16 |
| 2013 | 2 | — | 0 | 1 |
| 2014 | 5 | 104 | 0 | 4 |
| 2015 | 0 | — | 0 | 28 |
| 2016 | 1 | — | 0 | 28 |
| 2017 | 2 | — | 0 | 10 |
| 2018 | 2 | — | 0 | 19 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 1 | — | 0 | 6 |
| 2021 | 1 | — | 0 | 19 |
| 2022 | 0 | — | 0 | 8 |
| 2023 | 1 | — | 0 | 17 |
| 2024 | 0 | — | 0 | 7 |
| 2025 | 1 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Composite Removable Sinus Stent is intended for use in adult patients following ethmoid sinus surgery, to
maintain patency and reduce the need of post-operative intervention or revision surgery. The composite stent is
intended to be left inside the ethmoid sinus cavity for up to 28 days. The composite sinus stent provides steady
support of nasal walls against swelling mucosa, middle turbinate stabilization and prevents obstruction by
adhesions. The stent can be removed at any time within 28 days by cooling and self-crimping.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170913 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170913: Composite Removable Sinus Stent System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170913
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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