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 Mar 8, 2007 as substantially equivalent to K033483 (KLS-Martin L.P., 2004) and 1 other predicate after a 112-day review. Its family tree reaches back 3 generations to 1993.
- Decided
- Mar 8, 2007
- Review
- 112 days
- Class
- Class II
- Product code
- OAT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K925771 (1993). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK925771 Branemark System Titanium Cover ScrewsNobelpharma USA, Inc. · 1993
- 2 generations backK980460 Onplant Orthodontic SystemNobel Biocare Uas, Inc. · 1998
- 1 generation backK033483 KLS-Martin Ortho Anchorage SystemKLS-Martin L.P. · 2004
- This deviceK063473 Synthes Orthodontic Bone Anchor SystemSynthes (Usa) · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K925771 | Branemark System Titanium Cover Screws | Nobelpharma USA, Inc. | 1993 | — |
| −2 | K980460 | Onplant Orthodontic System | Nobel Biocare Uas, Inc. | 1998 | — |
| −1 | K033483 | KLS-Martin Ortho Anchorage System | KLS-Martin L.P. | 2004 | — |
| 0 (this device) | K063473 | Synthes Orthodontic Bone Anchor System | Synthes (Usa) | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2004 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K033483 | KLS-Martin Ortho Anchorage SystemSummary page 1…late Class fl, §872.4880 - Intraosseous fixation screw or wire Predicate Device: KLS-Martin Ortho Anchorage System - Screw Anchors K033483 KLS Martin Ortho Anchorage System - Plate Anchors K040891 Device Description: The Synthes (U… | 2004 |
| * | K040891 | KLS Martin Ortho Anchorage System (Plates)Summary page 1…wire Predicate Device: KLS-Martin Ortho Anchorage System - Screw Anchors K033483 KLS Martin Ortho Anchorage System - Plate Anchors K040891 Device Description: The Synthes (USA) Orthodontic Bone Anchor System is a plate and screw sy… | 2004 |
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 14 years and passes through 4 companies; a new generation was cleared every 5.1 years on median.
- None of the 11 ancestors has a recall.
- 4 other devices also cite its predicate K033483.
How does its category compare?
All OAT devicesOAT Implant, Endosseous, Orthodontic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 is intended to be implanted intraorally and used as an anchor for orthodontic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063473 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063473: 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/K063473
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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