510(k) · Cleared
ClearedSynthes Orthodontic Bone Anchor System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · OAT Implant, Endosseous, Orthodontic
Cleared on Dec 16, 2010 as substantially equivalent to K033767 (Jeil Medical Corporation, 2004) after a 421-day review. Its family tree reaches back 5 generations to 1990. 3 later devices descend from it.
- Decided
- Dec 16, 2010
- Review
- 421 days
- Class
- Class II
- Product code
- OAT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K894844 (1990). 16 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 4 generations backK973353 Bonding BaseStraumann USA · 1997
- 3 generations backK982509 Ortho Implant and AccessoriesStraumann USA · 1998
- 2 generations backK031936 Osteomed Orthodontic Screw SystemOsteomed LP · 2004
- 1 generation backK033767 Dual Top Anchor System ScrewsJeil Medical Corporation · 2004
- This deviceK093299 Synthes Orthodontic Bone Anchor SystemSynthes (Usa) · 2010
- Descendant · cites it directly · 1 of its ownK113650 Orthofix ScrewBonafix Surgical and Dental Implants, LLC · 2012
- Descendant · 2 generations on · 0 of its ownK201919 Blue Sky Bio TADBlue Sky Bio, LLC · 2020
- Descendant · cites it directly · 0 of its ownK183113 DePuy Synthes Maxillofacial Portfolio - MR ConditionalSynthes (USA) Products, LLC · 2019
Most influential descendants
Showing 3 of 3 · See all- K113650Orthofix ScrewBonafix Surgical and Dental Implants, LLC · 2012 · cites it directly1descendant
- K201919Blue Sky Bio TADBlue Sky Bio, LLC · 2020 · 2 generations on0descendants
- K183113DePuy Synthes Maxillofacial Portfolio - MR ConditionalSynthes (USA) Products, LLC · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| −4 | K973353 | Bonding Base | Straumann USA | 1997 | — |
| −3 | K982509 | Ortho Implant and Accessories | Straumann USA | 1998 | — |
| −2 | K031936 | Osteomed Orthodontic Screw System | Osteomed LP | 2004 | — |
| −1 | K033767 | Dual Top Anchor System Screws | Jeil Medical Corporation | 2004 | — |
| 0 (this device) | K093299 | Synthes Orthodontic Bone Anchor System | Synthes (Usa) | 2010 | — |
| +1 | K113650 | Orthofix Screw | Bonafix Surgical and Dental Implants, LLC | 2012 | — |
| +2 | K201919 | Blue Sky Bio TAD | Blue Sky Bio, LLC | 2020 | — |
| +1 | K183113 | DePuy Synthes Maxillofacial Portfolio - MR Conditional | Synthes (USA) Products, LLC | 2019 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 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? (2)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K060473 | FDA’s K060473 is TTC Plate Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2006 |
| * | K033767 | Dual Top Anchor System ScrewsSummary page 1…eous dental implant Predicate Devices: Synthes Orthodontic Bone Anchor System (K(06473) Jeil Medical Corporation Dual Top Anchor System Screws (K(033767) Device The Synthes (USA) Orthodontic Bone Anchor System is intended to be implanted Description: intraoral… | 2004 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 20 years and passes through 5 companies; a new generation was cleared every 5.3 years on median.
- None of the 16 ancestors has a recall.
- Of its descendants, K113650 (Bonafix Surgical and Dental Implants, LLC, 2012) has gone furthest, with 1 descendant of its own.
- 16 other devices also cite its predicate K033767.
How does its category compare?
All OAT devicesOAT Implant, Endosseous, Orthodontic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 Bone Anchor (OBA) System screw anchors are intended to be implanted intraorally and used as an anchor for orthodontic procedures in adolescents greater than age 12 and adults.
The Orthodontic Bone Anchor (OBA) System plate anchors are intended to be implanted intraorally and used as an anchor for orthodontic procedures in adults.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093299 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093299: Synthes Orthodontic Bone Anchor System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093299
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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