510(k) · Cleared
ClearedAlpha-Bio Orthodontic Fixation Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alpha-Bio Tec, Ltd. · OAT Implant, Endosseous, Orthodontic
Cleared on Mar 26, 2007 as substantially equivalent to K031936 (Osteomed LP, 2004) after a 96-day review. Its family tree reaches back 4 generations to 1990. 1 later device descends from it.
- Decided
- Mar 26, 2007
- Review
- 96 days
- Class
- Class II
- Product code
- OAT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K894844 (1990). 15 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 backK031936 Osteomed Orthodontic Screw SystemOsteomed LP · 2004
- This deviceK063770 Alpha-Bio Orthodontic Fixation Screw SystemAlpha-Bio Tec, Ltd. · 2007
- 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 | K031936 | Osteomed Orthodontic Screw System | Osteomed LP | 2004 | — |
| 0 (this device) | K063770 | Alpha-Bio Orthodontic Fixation Screw System | Alpha-Bio Tec, Ltd. | 2007 | — |
| +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 |
| 2000 | 1 | 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? (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 |
|---|---|---|---|
| * | K031936 | Osteomed Orthodontic Screw SystemSummary page 1…hodontic Fixation Screw System ® is substantially equivalent to Osteomed Orthodontic Screw System LA.P K031936 in terms of intended use, indications for use, technological characteristics,… | 2004 |
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)
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 17 years and passes through 4 companies; a new generation was cleared every 5.3 years on median.
- None of the 15 ancestors has a recall.
- Of its descendants, K072917 (Odontit S.A., 2008) has gone furthest, with 0 descendants of its own.
- 7 other devices also cite its predicate K031936.
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?
Alpha Bio Orthodontic Fixation Screw System® are intended to provide 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. Screws are intended for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063770 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063770: Alpha-Bio Orthodontic Fixation Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063770
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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