510(k) · Cleared
ClearedSynthes (Usa) 1.3 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 Jun 10, 2002 as substantially equivalent to K983485 (Synthes (Usa), 1998) after a 5-day review. Its family tree reaches back 2 generations to 1996. 32 later devices descend from it.
- Decided
- Jun 10, 2002
- Review
- 5 days
- Class
- Class II
- Product code
- DZL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K953806 (1996). 32 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK953806 Synthes (Usa) Midfacial SystemSynthes (Usa) · 1996
- 1 generation backK983485 Synthes 1.3 MM Self-Drilling ScrewSynthes (Usa) · 1998
- This deviceK021850 Synthes (Usa) 1.3 MM Craniofacial ScrewsSynthes (Usa) · 2002
- Descendant · cites it directly · 29 of its ownK091686 Leforte Neurosystem Bone ScrewJeil Medical Corporation · 2009
- Descendant · 2 generations on · 16 of its ownK112457 Leforte System Bone Plate & ScrewArkin Consulting Group · 2012
- Descendant · 2 generations on · 11 of its ownK112812 Leforte Neuro System Bone PlateJeil Medical Corporation · 2012
- Descendant · 3 generations on · 9 of its ownK131311 Arix Foot SystemJeil Medical Corporation · 2013
- Descendant · 4 generations on · 5 of its ownK161864 ARIX Foot SystemJeil Medical Corporation · 2016
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 32 · See all- K091686Leforte Neurosystem Bone ScrewJeil Medical Corporation · 2009 · cites it directly29descendants
- K112457Leforte System Bone Plate & ScrewArkin Consulting Group · 2012 · 2 generations on16descendants
- K112812Leforte Neuro System Bone PlateJeil Medical Corporation · 2012 · 2 generations on11descendants
- K131311Arix Foot SystemJeil Medical Corporation · 2013 · 3 generations on9descendants
- K161864ARIX Foot SystemJeil Medical Corporation · 2016 · 4 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K953806 | Synthes (Usa) Midfacial System | Synthes (Usa) | 1996 | — |
| −1 | K983485 | Synthes 1.3 MM Self-Drilling Screw | Synthes (Usa) | 1998 | — |
| 0 (this device) | K021850 | Synthes (Usa) 1.3 MM Craniofacial Screws | Synthes (Usa) | 2002 | — |
| +1 | K091686 | Leforte Neurosystem Bone Screw | Jeil Medical Corporation | 2009 | — |
| +2 | K112457 | Leforte System Bone Plate & Screw | Arkin Consulting Group | 2012 | — |
| +2 | K112812 | Leforte Neuro System Bone Plate | Jeil Medical Corporation | 2012 | — |
| +3 | K131311 | Arix Foot System | Jeil Medical Corporation | 2013 | — |
| +4 | K161864 | ARIX Foot System | Jeil Medical Corporation | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 5 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 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? (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 |
|---|---|---|---|
| * | K983485 | Synthes 1.3 MM Self-Drilling ScrewSummary page 1…Matthew M. Hull (610) 647-9700 Synthes (USA) 1.3 mm Craniofacial Screws Class I1, 21 CFR 872.4880 Screw, Fixation, Intraosseous Synthes 1.3 mm Self-Drilling Screws, K983485 Synthes Craniofacial screws are available with either self- tapping or self-tapping/self-drilling tips. They are offered in 1.3… | 1998 |
What descends from it? (32)
See all 322 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?
- The line of descent spans 6 years and passes through 1 company; a new generation was cleared every 3.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K091686 (Jeil Medical Corporation, 2009) has gone furthest, with 29 descendants of its own.
- 7 other devices also cite its predicate K983485.
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?
Synthes Craniofacial Screws are intended for selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K021850 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021850: Synthes (Usa) 1.3 MM Craniofacial Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021850
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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