510(k) · Cleared
Recalled · 2007Straumann Orthosystem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Institut Straumann AG · OAT Implant, Endosseous, Orthodontic
Cleared on Feb 3, 2006 as substantially equivalent to K982509 (Straumann USA, 1998) and 2 other predicates after a 25-day review. Its family tree reaches back 4 generations to 1990. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Feb 3, 2006
- Review
- 25 days
- Class
- Class II
- Product code
- OAT
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 4 generations to K894844 (1990). 17 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 3 generations backK973353 Bonding BaseStraumann USA · 1997
- 2 generations backK982509 Ortho Implant and AccessoriesStraumann USA · 1998
- 1 generation backK040469 The Straumann Ortho Implant SystemThe Straumann Co. · 2004
- This deviceK060062 Straumann OrthosystemInstitut Straumann AG · 2006
- Descendant · cites it directly · 0 of its ownK072917 JJG Evolution Orthodontic Implant SystemOdontit S.A. · 2008
Most influential descendants
Showing 1 of 1 · See all- K072917JJG Evolution Orthodontic Implant SystemOdontit S.A. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| −3 | K973353 | Bonding Base | Straumann USA | 1997 | — |
| −2 | K982509 | Ortho Implant and Accessories | Straumann USA | 1998 | — |
| −1 | K040469 | The Straumann Ortho Implant System | The Straumann Co. | 2004 | — |
| 0 (this device) | K060062 | Straumann Orthosystem | Institut Straumann AG | 2006 | — |
| +1 | 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 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 Orthosystem, originally cleared under K982509 and K040469 Straumann TE Dental Implants, originally cleared under K012757. 4. Description of the Device… | 1998 |
| * | K040469 | The Straumann Ortho Implant SystemSummary page 1…640 3. Legally Marketed Devices to which Equivalence is Claimed (Predicate Devices) Straumann Orthosystem, originally cleared under K982509 and K040469 Straumann TE Dental Implants, originally cleared under K012757. 4. Description of the Device The Straum… | 2004 |
| * | K012757 | Iti Dental Implant SystemSummary page 1…Predicate Devices) Straumann Orthosystem, originally cleared under K982509 and K040469 Straumann TE Dental Implants, originally cleared under K012757. 4. Description of the Device The Straumann Palatal Implant is a modification of the Straumann Ortho Im… | 2001 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072917 | JJG Evolution Orthodontic Implant System | 2008 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 28, 2007 | Not classified | Z-0277-2008 | Device Design | Sticking Transfer Piece: The Transfer Piece which accompanies the Palatal Implant may get stuck during implant requiring removal by using mechanical force. |
| Sep 28, 2007 | Not classified | Z-0278-2008 | Device Design | Sticking Transfer Piece: The Transfer Piece which accompanies the Palatal Implant may get stuck during implant requiring removal by using mechanical force. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 5.6 years on median.
- None of the 17 ancestors has a recall.
- Of its descendants, K072917 (Odontit S.A., 2008) has gone furthest, with 0 descendants 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 Straumann Palatal implant is 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 the 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. Palatal implants can be used in adults and juveniles age 12…
Read the full statement (117 words)
The Straumann Palatal implant is 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 the 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.
Palatal 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 palatal implants shouid be placed off the mid-line 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/K060062 · printed Nov 5, 2026
Cite this page
510(k) Report. “K060062: Straumann Orthosystem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060062
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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