510(k) · Cleared
ClearedSynthes 90 Degree Screwdriver
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · DZI Drill, Bone, Powered
Cleared on Apr 30, 2009 after a 230-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- Apr 30, 2009
- Review
- 230 days
- Class
- Class II
- Product code
- DZI
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK082649 Synthes 90 Degree ScrewdriverSynthes (Usa) · 2009
- Descendant · cites it directly · 1 of its ownK150392 PROPEL devicePropel Orthodontics, LLC · 2015
- Descendant · cites it directly · 0 of its ownK253655 Angled Screwdriver MED (M-SD090)W&H Dentalwerk Bürmoos GmbH · 2026
- Descendant · 2 generations on · 0 of its ownK172164 PROPEL DevicePropel Orthodontics, LLC · 2018
- Descendant · cites it directly · 0 of its ownK150796 Dental Bone Cutting InstrumentsSynthes (USA) Products, LLC · 2015
Most influential descendants
Showing 4 of 4 · See all- K150392PROPEL devicePropel Orthodontics, LLC · 2015 · cites it directly1descendant
- K253655Angled Screwdriver MED (M-SD090)W&H Dentalwerk Bürmoos GmbH · 2026 · cites it directly0descendants
- K172164PROPEL DevicePropel Orthodontics, LLC · 2018 · 2 generations on0descendants
- K150796Dental Bone Cutting InstrumentsSynthes (USA) Products, LLC · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K082649 | Synthes 90 Degree Screwdriver | Synthes (Usa) | 2009 | — |
| +1 | K150392 | PROPEL device | Propel Orthodontics, LLC | 2015 | — |
| +1 | K253655 | Angled Screwdriver MED (M-SD090) | W&H Dentalwerk Bürmoos GmbH | 2026 | — |
| +2 | K172164 | PROPEL Device | Propel Orthodontics, LLC | 2018 | — |
| +1 | K150796 | Dental Bone Cutting Instruments | Synthes (USA) Products, LLC | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 2018 | 1 | 0 |
| 2026 | 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 DZI? 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 DZI device
- #1 K253776 Implantmed Plus II & Piezomed Plus II Modulescore 12.1 · 3 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 |
|---|---|---|---|
| * | — | Synthes Electric Pen Drive System Named without a submission number |
What descends from it? (4)
3 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?
- Of its descendants, K150392 (Propel Orthodontics, LLC, 2015) has gone furthest, with 1 descendant of its own.
How does its category compare?
All DZI devicesDZI Drill, Bone, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · DZI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DZI
300in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DZI
1in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DZI
39in 2025
MAUDE reports naming product code DZI, 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 | 2 | — | 0 | 53 |
| 2008 | 4 | 171 | 0 | 45 |
| 2009 | 5 | 220 | 1 | 22 |
| 2010 | 0 | — | 0 | 15 |
| 2011 | 2 | — | 0 | 42 |
| 2012 | 4 | 191 | 0 | 25 |
| 2013 | 0 | — | 0 | 57 |
| 2014 | 1 | — | 0 | 50 |
| 2015 | 3 | 123 | 0 | 39 |
| 2016 | 1 | — | 0 | 43 |
| 2017 | 0 | — | 0 | 38 |
| 2018 | 3 | 290 | 0 | 73 |
| 2019 | 0 | — | 0 | 50 |
| 2020 | 3 | 300 | 0 | 55 |
| 2021 | 0 | — | 0 | 84 |
| 2022 | 0 | — | 0 | 63 |
| 2023 | 1 | — | 0 | 63 |
| 2024 | 2 | — | 0 | 58 |
| 2025 | 1 | — | 0 | 39 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Synthes 90 0 Screwdriver is indicated for the manual and powered pre-drilling and insertion of bone fixation screws in oral/maxillofacial surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082649 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082649: Synthes 90 Degree Screwdriver.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082649
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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