510(k) · Cleared
ClearedOrthofix Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bonafix Surgical and Dental Implants, LLC · OAT Implant, Endosseous, Orthodontic
Cleared on Oct 3, 2012 as substantially equivalent to K093299 (Synthes (Usa), 2010) and 1 other predicate after a 296-day review. Its family tree reaches back 6 generations to 1990. 1 later device descends from it.
- Decided
- Oct 3, 2012
- Review
- 296 days
- Class
- Class II
- Product code
- OAT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K894844 (1990). 17 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 5 generations backK973353 Bonding BaseStraumann USA · 1997
- 4 generations backK982509 Ortho Implant and AccessoriesStraumann USA · 1998
- 3 generations backK031936 Osteomed Orthodontic Screw SystemOsteomed LP · 2004
- 2 generations backK033767 Dual Top Anchor System ScrewsJeil Medical Corporation · 2004
- 1 generation backK093299 Synthes Orthodontic Bone Anchor SystemSynthes (Usa) · 2010
- This deviceK113650 Orthofix ScrewBonafix Surgical and Dental Implants, LLC · 2012
- Descendant · cites it directly · 0 of its ownK201919 Blue Sky Bio TADBlue Sky Bio, LLC · 2020
Most influential descendants
Showing 1 of 1 · See all- K201919Blue Sky Bio TADBlue Sky Bio, LLC · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| −5 | K973353 | Bonding Base | Straumann USA | 1997 | — |
| −4 | K982509 | Ortho Implant and Accessories | Straumann USA | 1998 | — |
| −3 | K031936 | Osteomed Orthodontic Screw System | Osteomed LP | 2004 | — |
| −2 | K033767 | Dual Top Anchor System Screws | Jeil Medical Corporation | 2004 | — |
| −1 | K093299 | Synthes Orthodontic Bone Anchor System | Synthes (Usa) | 2010 | — |
| 0 (this device) | K113650 | Orthofix Screw | Bonafix Surgical and Dental Implants, LLC | 2012 | — |
| +1 | K201919 | Blue Sky Bio TAD | Blue Sky Bio, LLC | 2020 | — |
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 |
|---|---|---|
| 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K093299 | Synthes Orthodontic Bone Anchor SystemSummary page 1…Predicate Devices: * Screw Anchor of the SYNTHES Orthodontic Bone Anchor System; SYNTHES (USA) - (reference 5 10(k) K093299 determined substantially equivalent on December 16, 2010). * Dual Top Anchor Syst… | 2010 |
| * | K033767 | Dual Top Anchor System ScrewsSummary page 1…ned substantially equivalent on December 16, 2010). * Dual Top Anchor System Screw; Jeil Medical Corp.- (reference 510(k) K033767, determined substantially equivalent on February 24, 2004). Device Description: The Ort… | 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 |
|---|---|---|---|
| K201919 | Blue Sky Bio TAD | 2020 | 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 22 years and passes through 6 companies; a new generation was cleared every 5.3 years on median.
- None of the 17 ancestors has a recall.
- Of its descendants, K201919 (Blue Sky Bio, LLC, 2020) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K093299.
How does its category compare?
All OAT devicesOAT Implant, Endosseous, Orthodontic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 proposed OrthoFix Screw is 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 a single use only. For use in adolescents greater than age 12 and adults.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113650 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113650: Orthofix Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113650
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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