510(k) · Cleared
ClearedOrtho MI System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteonic Co., Ltd. · OAT Implant, Endosseous, Orthodontic
Cleared on Oct 15, 2021 as substantially equivalent to K103105 (Osstem Implant Co., Ltd., 2011) after a 109-day review. Its family tree reaches back 7 generations to 1990.
- Decided
- Oct 15, 2021
- Review
- 109 days
- Class
- Class II
- Product code
- OAT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K894844 (1990). 18 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 6 generations backK973353 Bonding BaseStraumann USA · 1997
- 5 generations backK982509 Ortho Implant and AccessoriesStraumann USA · 1998
- 4 generations backK031936 Osteomed Orthodontic Screw SystemOsteomed LP · 2004
- 3 generations backK033767 Dual Top Anchor System ScrewsJeil Medical Corporation · 2004
- 2 generations backK062156 Super Orthodontic ScrewOsstem Implant Co., Ltd. · 2006
- 1 generation backK103105 Orthodontic ScrewOsstem Implant Co., Ltd. · 2011
- This deviceK211992 Ortho MI SystemOsteonic Co., Ltd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| −6 | K973353 | Bonding Base | Straumann USA | 1997 | — |
| −5 | K982509 | Ortho Implant and Accessories | Straumann USA | 1998 | — |
| −4 | K031936 | Osteomed Orthodontic Screw System | Osteomed LP | 2004 | — |
| −3 | K033767 | Dual Top Anchor System Screws | Jeil Medical Corporation | 2004 | — |
| −2 | K062156 | Super Orthodontic Screw | Osstem Implant Co., Ltd. | 2006 | — |
| −1 | K103105 | Orthodontic Screw | Osstem Implant Co., Ltd. | 2011 | — |
| 0 (this device) | K211992 | Ortho MI System | Osteonic Co., Ltd. | 2021 | — |
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 |
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 |
|---|---|---|---|
| * | K103105 | Orthodontic ScrewSummary page 4…moved after orthodontic treatment has been completed. It is intended for single use only. 06. Predicate devices Predicate device 510(k) Number: K103105 Device Name: Orthodontic screw Manufacturer: OSSTEM Implant Co., Ltd. Reference device 510(k) Nu… | 2011 |
| † | K161335 | Dual Top Screw System | 2017 |
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 31 years and passes through 6 companies; a new generation was cleared every 4.4 years on median.
- None of the 18 ancestors has a recall.
- 1 other device also cites its predicate K103105.
How does its category compare?
All OAT devicesOAT Implant, Endosseous, Orthodontic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 ORTHO MI SYSTEM is indicated for use as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. It is intended for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211992 · printed Nov 5, 2026
Cite this page
510(k) Report. “K211992: Ortho MI System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K211992
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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