510(k) · Cleared
ClearedThe Straumann Ortho Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Straumann Co. · OAT Implant, Endosseous, Orthodontic
Cleared on Apr 30, 2004 as substantially equivalent to K982509 (Straumann USA, 1998) after a 66-day review. Its family tree reaches back 3 generations to 1990. 2 later devices descend from it.
- Decided
- Apr 30, 2004
- Review
- 66 days
- Class
- Class II
- Product code
- OAT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K894844 (1990). 13 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 2 generations backK973353 Bonding BaseStraumann USA · 1997
- 1 generation backK982509 Ortho Implant and AccessoriesStraumann USA · 1998
- This deviceK040469 The Straumann Ortho Implant SystemThe Straumann Co. · 2004
- Descendant · cites it directly · 1 of its ownK060062 Straumann OrthosystemInstitut Straumann AG · 2006 · Recalled
- Descendant · 2 generations on · 0 of its ownK072917 JJG Evolution Orthodontic Implant SystemOdontit S.A. · 2008
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| −2 | K973353 | Bonding Base | Straumann USA | 1997 | — |
| −1 | K982509 | Ortho Implant and Accessories | Straumann USA | 1998 | — |
| 0 (this device) | K040469 | The Straumann Ortho Implant System | The Straumann Co. | 2004 | — |
| +1 | K060062 | Straumann Orthosystem | Institut Straumann AG | 2006 | 2 |
| +2 | K072917 | JJG Evolution Orthodontic Implant System | Odontit S.A. | 2008 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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 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 |
|---|---|---|---|
| * | K982509 | Ortho Implant and AccessoriesSummary page 1…21 CFR 872.3640 3. Legally Marketed Devices to which Equivalence is Claimed (Predicate Devices) Straumann Ortho System (K982509) 4. Description of the Device The Ortho implant is a solid, one-piece, threaded, self-tapping design made fr… | 1998 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060062 | Straumann Orthosystem | 2006 | 1 |
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 14 years and passes through 3 companies; a new generation was cleared every 5.6 years on median.
- None of the 13 ancestors has a recall.
- Of its descendants, K060062 (Institut Straumann AG, 2006) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K982509.
How does its category compare?
All OAT devicesOAT Implant, Endosseous, Orthodontic: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 implant of the Straumann Ortho system is an endosseous implant intended for placement in the mid-sagittal or paramedian area of the hard palate or in retromolar positions. Its purpose is to provide a fixed anchorage point for attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth. It is used temporarily and is intended to be removed after orthodontic treatment has been completed. Ortho implants can be used…
Read the full statement (123 words)
The Ortho implant of the Straumann Ortho system is an endosseous implant intended for placement in the mid-sagittal or paramedian area of the hard palate or in retromolar positions. Its purpose is to provide a fixed anchorage point for attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth. It is used temporarily and is intended to be removed after orthodontic treatment has been completed.
Ortho implants can be used in adults and juveniles (age 12 and older). In case of patients who have not yet completed skeletal growth (e.g. as shown by radiographic analysis of the hand/wrist), the ortho implant should be placed off the midline in the paramedian region of the palate in order to avoid the mid-palatal suture.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K040469 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040469: The Straumann Ortho Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040469
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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