510(k) · Cleared
ClearedOrthodontic Fixation Screw [Smart Anchor Miniscrew]
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gni Co., Ltd. · OAT Implant, Endosseous, Orthodontic
Cleared on Aug 28, 2020 as substantially equivalent to K161335 (Jeil Medical Corporation, 2017) after a 497-day review. Its family tree reaches back 11 generations to 1990.
- Decided
- Aug 28, 2020
- Review
- 497 days
- Class
- Class II
- Product code
- OAT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K894844 (1990). 27 ancestors in all. No later device cites it as a predicate yet.
- Root · 11 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 7 generations between
- 3 generations backK090476 Syntec Orthodontic Mini ScrewSyntec Scientific Corp. · 2009
- 2 generations backK110392 PSM Lomas / Benefit ScrewsPsm Medical Solutions · 2011
- 1 generation backK161335 Dual Top Screw SystemJeil Medical Corporation · 2017
- This deviceK191041 Orthodontic Fixation Screw [Smart Anchor Miniscrew]Gni Co., Ltd. · 2020
Show all 11 generations
- Root · 11 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 10 generations backK973353 Bonding BaseStraumann USA · 1997
- 9 generations backK982509 Ortho Implant and AccessoriesStraumann USA · 1998
- 8 generations backK031936 Osteomed Orthodontic Screw SystemOsteomed LP · 2004
- 7 generations backK033767 Dual Top Anchor System ScrewsJeil Medical Corporation · 2004
- 6 generations backK042965 Tomas PinDentaurum, Inc. · 2005
- 5 generations backK060126 Absoanchor MicroimplantDentos, Inc. · 2006
- 4 generations backK071490 Leone Orthodontic Mini ImplantLeone S.P.A. · 2008
- 3 generations backK090476 Syntec Orthodontic Mini ScrewSyntec Scientific Corp. · 2009
- 2 generations backK110392 PSM Lomas / Benefit ScrewsPsm Medical Solutions · 2011
- 1 generation backK161335 Dual Top Screw SystemJeil Medical Corporation · 2017
- This deviceK191041 Orthodontic Fixation Screw [Smart Anchor Miniscrew]Gni Co., Ltd. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| −10 | K973353 | Bonding Base | Straumann USA | 1997 | — |
| −9 | K982509 | Ortho Implant and Accessories | Straumann USA | 1998 | — |
| −8 | K031936 | Osteomed Orthodontic Screw System | Osteomed LP | 2004 | — |
| −7 | K033767 | Dual Top Anchor System Screws | Jeil Medical Corporation | 2004 | — |
| −6 | K042965 | Tomas Pin | Dentaurum, Inc. | 2005 | — |
| −5 | K060126 | Absoanchor Microimplant | Dentos, Inc. | 2006 | — |
| −4 | K071490 | Leone Orthodontic Mini Implant | Leone S.P.A. | 2008 | — |
| −3 | K090476 | Syntec Orthodontic Mini Screw | Syntec Scientific Corp. | 2009 | — |
| −2 | K110392 | PSM Lomas / Benefit Screws | Psm Medical Solutions | 2011 | — |
| −1 | K161335 | Dual Top Screw System | Jeil Medical Corporation | 2017 | — |
| 0 (this device) | K191041 | Orthodontic Fixation Screw [Smart Anchor Miniscrew] | Gni Co., Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 3 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2007 | 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 |
|---|---|---|---|
| * | K161335 | Dual Top Screw SystemSummary page 4…ode: OAT Regulation Numbers: 21 CFR 872.3640 Predicate Device: The identified predicate devices within this submission are shown as follow; Primary Predicate: K161335 Applicant: Jeil Medical Corporation Common Name: Implant, Endosseous, Orthodontic Device Name: Dual Top S… | 2017 |
| † | K161197 | Orthodontic Screw | 2016 |
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 30 years and passes through 10 companies; a new generation was cleared every 1.8 years on median.
- None of the 27 ancestors has a recall.
- 2 other devices also cite its predicate K161335.
How does its category compare?
All OAT devicesOAT Implant, Endosseous, Orthodontic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 Orthodontic Fixation Screw [Smart Anchor Miniscrew] is intended for use as a temporary anchor for orthodontic treatment for use in patients aged 12 and older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191041 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191041: Orthodontic Fixation Screw [Smart Anchor Miniscrew].” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191041
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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