510(k) · Cleared
ClearedHDC Sterile Self Ligating Spider Screw, Model Sli,SL2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hdc S.R.L. · OAT Implant, Endosseous, Orthodontic
Cleared on Jul 30, 2009 as substantially equivalent to K071851 (Hdc S.R.L., 2007) after an 80-day review. Its family tree reaches back 8 generations to 1990.
- Decided
- Jul 30, 2009
- Review
- 80 days
- Class
- Class II
- Product code
- OAT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K894844 (1990). 23 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 7 generations backK973353 Bonding BaseStraumann USA · 1997
- 6 generations backK982509 Ortho Implant and AccessoriesStraumann USA · 1998
- 5 generations backK031936 Osteomed Orthodontic Screw SystemOsteomed LP · 2004
- 4 generations backK033767 Dual Top Anchor System ScrewsJeil Medical Corporation · 2004
- 3 generations backK042965 Tomas PinDentaurum, Inc. · 2005
- 2 generations backK052471 HDC Spider ScrewHdc S.R.L. · 2005
- 1 generation backK071851 HDC Sterile Spider ScrewHdc S.R.L. · 2007
- This deviceK091390 HDC Sterile Self Ligating Spider Screw, Model Sli,SL2Hdc S.R.L. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| −7 | K973353 | Bonding Base | Straumann USA | 1997 | — |
| −6 | K982509 | Ortho Implant and Accessories | Straumann USA | 1998 | — |
| −5 | K031936 | Osteomed Orthodontic Screw System | Osteomed LP | 2004 | — |
| −4 | K033767 | Dual Top Anchor System Screws | Jeil Medical Corporation | 2004 | — |
| −3 | K042965 | Tomas Pin | Dentaurum, Inc. | 2005 | — |
| −2 | K052471 | HDC Spider Screw | Hdc S.R.L. | 2005 | — |
| −1 | K071851 | HDC Sterile Spider Screw | Hdc S.R.L. | 2007 | — |
| 0 (this device) | K091390 | HDC Sterile Self Ligating Spider Screw, Model Sli,SL2 | Hdc S.R.L. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 3 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 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 OAT? 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 OAT device
- #1 K260268 OrthoEasy Pal; OrthoEasy Pal Long Neckscore 13.2 · 7 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 |
|---|---|---|---|
| * | K071851 | HDC Sterile Spider ScrewSummary page 2…d States: IApplicant Device name I 510(k) Number J HDC S.r.l. HDC Sterile Spider Screw K071851 The components of Sterile Self Ligating Spider Screw have been compared in terms of intended use, design characteristics, and sa… | 2007 |
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 19 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
- None of the 23 ancestors has a recall.
- 1 other device also cites its predicate K071851.
How does its category compare?
All OAT devicesOAT Implant, Endosseous, Orthodontic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · OAT
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OAT
224in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OAT
2in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OAT
5in 2025
MAUDE reports naming product code OAT, 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 | 6 | 104 | 2 | 2 |
| 2008 | 3 | 94 | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 1 |
| 2011 | 5 | 152 | 0 | 0 |
| 2012 | 1 | — | 0 | 3 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 1 | — | 0 | 4 |
| 2015 | 1 | — | 0 | 28 |
| 2016 | 2 | — | 0 | 12 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 3 | 289 | 0 | 38 |
| 2021 | 4 | 224 | 0 | 68 |
| 2022 | 2 | — | 0 | 84 |
| 2023 | 1 | — | 0 | 78 |
| 2024 | 2 | — | 0 | 9 |
| 2025 | 1 | — | 0 | 5 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Sterile Self Ligating Spider Screw is a threaded titanium dental implant screw, intended to serve as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of the teeth. The device is used temporarily and shall be removed after orthodontic treatment has been completed. It is provided sterile and is intended for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091390 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091390: HDC Sterile Self Ligating Spider Screw, Model Sli,SL2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091390
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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