510(k) · Cleared
ClearedSis Sinus Implant Stabilizer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mondeal Medical Systems GmbH · JEY Plate, Bone
Cleared on Jul 30, 2007 as substantially equivalent to K990342 (Straumann USA, 1999) and 4 other predicates after a 343-day review. Its family tree reaches back 2 generations to 1990.
- Decided
- Jul 30, 2007
- Review
- 343 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 2 generations to K894844 (1990). 7 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| −1 | K990342 | Synocta Prosthetics | Straumann USA | 1999 | — |
| 0 (this device) | K062436 | Sis Sinus Implant Stabilizer | Mondeal Medical Systems GmbH | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 3 | 0 |
| 2005 | 2 | 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 JEY? 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 JEY device
- #1 K252246 Leforte MMF Systemscore 15.6 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K990342 | Synocta ProstheticsSummary page 1…on: Class 11 Common Name: Bone Plate Classification Name: Endosseous Implant Predicate * Synocta Prosthetics, K990342 Devices: * Mini Bone Plate System, K951392 * Micro Titanium Plate System, K951688 * Lin/Li… | 1999 |
| * | K951392 | Miniboneplate SystemSummary page 1…Bone Plate Classification Name: Endosseous Implant Predicate * Synocta Prosthetics, K990342 Devices: * Mini Bone Plate System, K951392 * Micro Titanium Plate System, K951688 * Lin/Liou Orthodontic Mini Anchor System (LOMAS),… | 1995 |
| * | K951688 | Micro Titanium Plate SystemSummary page 1…Name: Endosseous Implant Predicate * Synocta Prosthetics, K990342 Devices: * Mini Bone Plate System, K951392 * Micro Titanium Plate System, K951688 * Lin/Liou Orthodontic Mini Anchor System (LOMAS), K042345 & K050257 Device The SIS S… | 1995 |
| * | K042345 | Lin/Liou Orthodontic Mini Anchor System (Lomas)Summary page 1…ni Bone Plate System, K951392 * Micro Titanium Plate System, K951688 * Lin/Liou Orthodontic Mini Anchor System (LOMAS), K042345 & K050257 Device The SIS Sinus Implant Stabilizer consists of a titanium plate Description: provided with 3 large pe… | 2005 |
| * | K050257 | Lin/Liou Orthodontic Mini Anchor System (Lomas) (Sterile)Summary page 1…ate System, K951392 * Micro Titanium Plate System, K951688 * Lin/Liou Orthodontic Mini Anchor System (LOMAS), K042345 & K050257 Device The SIS Sinus Implant Stabilizer consists of a titanium plate Description: provided with 3 large perforations… | 2005 |
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 17 years and passes through 3 companies; a new generation was cleared every 9.5 years on median.
- None of the 7 ancestors has a recall.
- 13 other devices also cite its predicate K990342.
How does its category compare?
All JEY devicesJEY Plate, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · JEY
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JEY
159in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JEY
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JEY
1,003in 2025
MAUDE reports naming product code JEY, 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 | 9 | 115 | 0 | 29 |
| 2008 | 7 | 84 | 3 | 24 |
| 2009 | 4 | 121 | 6 | 93 |
| 2010 | 6 | 199 | 85 | 215 |
| 2011 | 5 | 75 | 0 | 241 |
| 2012 | 10 | 194 | 0 | 428 |
| 2013 | 8 | 126 | 1 | 766 |
| 2014 | 6 | 223 | 0 | 616 |
| 2015 | 7 | 160 | 0 | 767 |
| 2016 | 1 | — | 0 | 558 |
| 2017 | 5 | 190 | 0 | 568 |
| 2018 | 7 | 255 | 0 | 608 |
| 2019 | 6 | 163 | 0 | 595 |
| 2020 | 6 | 198 | 1 | 680 |
| 2021 | 4 | 299 | 0 | 451 |
| 2022 | 5 | 135 | 0 | 344 |
| 2023 | 2 | — | 0 | 495 |
| 2024 | 5 | 159 | 0 | 696 |
| 2025 | 2 | — | 0 | 1,003 |
| 2026 | 3 | 258 | 0 | — |
What is it indicated for?
The SIS Sinus Implant Stabilizer is intended to provide a
fixed anchorage point to stabilize dental implants in the sinus
region, enabling sinus augmentation and implantation to be carried
out in one session.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062436 · printed Nov 5, 2026
Cite this page
510(k) Report. “K062436: Sis Sinus Implant Stabilizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062436
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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