510(k) · Cleared
ClearedSynthes 1.3 MM Self-Drilling Screw
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 Dec 21, 1998 as substantially equivalent to K953806 (Synthes (Usa), 1996) after a 77-day review. Its family tree reaches back 1 generation to 1996. 171 later devices descend from it.
- Decided
- Dec 21, 1998
- Review
- 77 days
- Class
- Class II
- Product code
- DZL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K953806 (1996). 171 later devices descend from it, 8 citing it directly.
- Root · 1 generation backK953806 Synthes (Usa) Midfacial SystemSynthes (Usa) · 1996
- This deviceK983485 Synthes 1.3 MM Self-Drilling ScrewSynthes (Usa) · 1998
- Descendant · cites it directly · 117 of its ownK013954 Lorenz Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2002
- Descendant · 2 generations on · 101 of its ownK032228 Lorenz 2.4 Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2003
- Descendant · 3 generations on · 100 of its ownK033740 Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc. · 2003
- Descendant · 2 generations on · 87 of its ownK063506 Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc. · 2006
- Descendant · 3 generations on · 84 of its ownK110574 Biomet Microfixation Sternalock Blu Sternal Closure SystemBiomet Microfixation, Inc. · 2011 · Recalled
Showing 5 of 171 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 171 · See all- K013954Lorenz Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2002 · cites it directly117descendants
- K032228Lorenz 2.4 Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2003 · 2 generations on101descendants
- K033740Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc. · 2003 · 3 generations on100descendants
- K063506Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc. · 2006 · 2 generations on87descendants
- K110574Biomet Microfixation Sternalock Blu Sternal Closure SystemBiomet Microfixation, Inc. · 2011 · 3 generations on84descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K953806 | Synthes (Usa) Midfacial System | Synthes (Usa) | 1996 | — |
| 0 (this device) | K983485 | Synthes 1.3 MM Self-Drilling Screw | Synthes (Usa) | 1998 | — |
| +1 | K013954 | Lorenz Self Drilling Screws | Walter Lorenz Surgical, Inc. | 2002 | — |
| +2 | K032228 | Lorenz 2.4 Self Drilling Screws | Walter Lorenz Surgical, Inc. | 2003 | — |
| +3 | K033740 | Lorenz Sternal Closure System | Walter Lorenz Surgical, Inc. | 2003 | — |
| +2 | K063506 | Lorenz Sternal Closure System | Walter Lorenz Surgical, Inc. | 2006 | — |
| +3 | K110574 | Biomet Microfixation Sternalock Blu Sternal Closure System | Biomet Microfixation, Inc. | 2011 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 4 | 0 |
| 2003 | 6 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 5 | 0 |
| 2012 | 8 | 0 |
| 2013 | 4 | 0 |
| 2014 | 11 | 0 |
| 2015 | 11 | 0 |
| 2016 | 9 | 0 |
| 2017 | 4 | 0 |
| 2018 | 7 | 0 |
| 2019 | 9 | 0 |
| 2020 | 4 | 0 |
| 2021 | 5 | 0 |
| 2022 | 10 | 0 |
| 2023 | 11 | 0 |
| 2024 | 16 | 0 |
| 2025 | 17 | 0 |
| 2026 | 17 | 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 |
|---|---|---|---|
| * | K953806 | Synthes (Usa) Midfacial SystemSummary page 1…00 Contact: Sheri L. Musgnung COMMON OR USUAL Screw, Fixation Bone NAME DEVICE Class I, 21 CFR 888.3030 CLASSIFICATION: PREDICATE DEVICE: Synthes Midfacial System (K953806) DESCRIPTION: Synthes 1.3 mm Self-Drilling Screws feature self-drilling self- tapping tips, stardrive recessed head, and are av… | 1996 |
What descends from it? (171)
See all 1718 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K013954 | Lorenz Self Drilling Screws | 2002 | 117 |
| K021850 | Synthes (Usa) 1.3 MM Craniofacial Screws | 2002 | 32 |
| K023260 | 1.2MM Osteomed Auto-Drive Screw System | 2002 | 24 |
| K022890 | Modified Screw Designs for Use with the Bioplate Rigid Fixation Bone Plating System for… | 2002 | 7 |
| K030806 | Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery | 2003 | 5 |
| K140037 | Optimus CMF System | 2015 | 2 |
| K102656 | Synthes Dentoalveolar Bone Fixation System | 2010 | 1 |
| K992106 | Modus System Self-Drilling Screws | 1999 | 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?
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 1.3 mm Self-Drilling 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/K983485 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983485: Synthes 1.3 MM Self-Drilling Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983485
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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