510(k) · Cleared
ClearedSynthes (Usa) 1.0/1.22 MM Craniofacial Screws
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · DZL Screw, Fixation, Intraosseous
Cleared on Aug 19, 2004 after a 38-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Aug 19, 2004
- Review
- 38 days
- Class
- Class II
- Product code
- DZL
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK041887 Synthes (Usa) 1.0/1.22 MM Craniofacial ScrewsSynthes (Usa) · 2004
- Descendant · cites it directly · 0 of its ownK192702 DePuy Synthes Craniomaxillofacial Neuro Devices - MR ConditionalSynthes (USA) Products, LLC · 2020
- Descendant · cites it directly · 0 of its ownK183113 DePuy Synthes Maxillofacial Portfolio - MR ConditionalSynthes (USA) Products, LLC · 2019
- Descendant · cites it directly · 0 of its ownK132212 Dental Bone Screws; Dental Bone Screws, Continuing; Screw System TX…Hager& Meisinger GmbH · 2014
Most influential descendants
Showing 3 of 3 · See all- K192702DePuy Synthes Craniomaxillofacial Neuro Devices - MR ConditionalSynthes (USA) Products, LLC · 2020 · cites it directly0descendants
- K183113DePuy Synthes Maxillofacial Portfolio - MR ConditionalSynthes (USA) Products, LLC · 2019 · cites it directly0descendants
- K132212Dental Bone Screws; Dental Bone Screws, Continuing; Screw System TX; Screw System TX…Hager& Meisinger GmbH · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K041887 | Synthes (Usa) 1.0/1.22 MM Craniofacial Screws | Synthes (Usa) | 2004 | — |
| +1 | K192702 | DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional | Synthes (USA) Products, LLC | 2020 | — |
| +1 | K183113 | DePuy Synthes Maxillofacial Portfolio - MR Conditional | Synthes (USA) Products, LLC | 2019 | — |
| +1 | K132212 | Dental Bone Screws; Dental Bone Screws, Continuing; Screw System TX; Screw… | Hager& Meisinger GmbH | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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 DZL? 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 DZL device
- #1 K254286 Guided Bone Regeneration Systemscore 12.2 · 2 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 |
|---|---|---|---|
| * | — | KLS Martin 1.0amm System Center-Drive Screw System Named without a submission number | |
| * | — | Synthes Maxillofacial Titanium Micro Set Named without a submission number |
What descends from it? (3)
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, K192702 (Synthes (USA) Products, LLC, 2020) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DZL devicesDZL Screw, Fixation, Intraosseous: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DZL
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DZL
263in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DZL
3in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DZL
70in 2025
MAUDE reports naming product code DZL, 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 | 1 | — | 0 | 4 |
| 2008 | 2 | — | 0 | 1 |
| 2009 | 2 | — | 1 | 8 |
| 2010 | 3 | 89 | 1 | 17 |
| 2011 | 2 | — | 0 | 12 |
| 2012 | 0 | — | 0 | 236 |
| 2013 | 1 | — | 3 | 178 |
| 2014 | 2 | — | 0 | 106 |
| 2015 | 1 | — | 0 | 103 |
| 2016 | 1 | — | 0 | 34 |
| 2017 | 3 | 277 | 0 | 74 |
| 2018 | 0 | — | 0 | 57 |
| 2019 | 2 | — | 0 | 50 |
| 2020 | 1 | — | 0 | 85 |
| 2021 | 1 | — | 0 | 55 |
| 2022 | 0 | — | 0 | 162 |
| 2023 | 2 | — | 0 | 100 |
| 2024 | 2 | — | 0 | 106 |
| 2025 | 4 | 263 | 0 | 70 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Synthes 1.0/1.2 mm craniofacial screws are intended for use as follows:
Specific Indications:
* Nasoethmoidal fractures
* Infraorbital area fractures
* Frontal sinus wall fractures
* Infant craniofacial surgery
General Indications:
* Maxillofacial surgery
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041887 · printed Nov 4, 2026
Cite this page
510(k) Report. “K041887: Synthes (Usa) 1.0/1.22 MM Craniofacial Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041887
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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