510(k) · Cleared
ClearedSMF Titanium (TI) Alloy Bone 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 24, 1997 after a 292-day review. The FDA summary names its predicate without a number. 460 later devices descend from it.
- Decided
- Jun 24, 1997
- Review
- 292 days
- Class
- Class II
- Product code
- DZL
- Recalls
- None
- Predicates
- 0
460 later devices descend from it, 3 citing it directly.
- This deviceK963546 SMF Titanium (TI) Alloy Bone ScrewsSynthes (Usa) · 1997
- Descendant · cites it directly · 457 of its ownK974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998
- Descendant · 2 generations on · 444 of its ownK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
- Descendant · 2 generations on · 435 of its ownK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
- Descendant · 3 generations on · 360 of its ownK040598 KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004
- Descendant · 4 generations on · 343 of its ownK050868 MaxlockOrthohelix Surgical Designs, Inc. · 2005
Showing 5 of 460 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 460 · See all- K974555Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998 · cites it directly457descendants
- K030448Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003 · 2 generations on444descendants
- K032442KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003 · 2 generations on435descendants
- K040598KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004 · 3 generations on360descendants
- K050868MaxlockOrthohelix Surgical Designs, Inc. · 2005 · 4 generations on343descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K963546 | SMF Titanium (TI) Alloy Bone Screws | Synthes (Usa) | 1997 | — |
| +1 | K974555 | Synthes 2.0 MM Locking Plate System (2.0 LPS) | Synthes (Usa) | 1998 | — |
| +2 | K030448 | Osteomed 2.0 Locking Plates and Screws | Osteomed LP | 2003 | — |
| +2 | K032442 | KLS-Martin Mandibular/Reconstruction System II | KLS-Martin L.P. | 2003 | — |
| +3 | K040598 | KLS Martin Hand Plating System | KLS-Martin L.P. | 2004 | — |
| +4 | K050868 | Maxlock | Orthohelix Surgical Designs, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2003 | 4 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 7 | 0 |
| 2011 | 4 | 0 |
| 2012 | 17 | 0 |
| 2013 | 10 | 0 |
| 2014 | 21 | 0 |
| 2015 | 28 | 0 |
| 2016 | 18 | 0 |
| 2017 | 32 | 0 |
| 2018 | 18 | 0 |
| 2019 | 22 | 0 |
| 2020 | 29 | 0 |
| 2021 | 28 | 0 |
| 2022 | 29 | 0 |
| 2023 | 39 | 0 |
| 2024 | 54 | 0 |
| 2025 | 40 | 0 |
| 2026 | 51 | 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? (4)
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 1.0 mm bone screws Named without a submission number | |
| * | — | Synthes 1.3 mm bone screws Named without a submission number | |
| * | — | Synthes 2.0 mm bone screws Named without a submission number | |
| * | — | Synthes 2.4 mm bone screws Named without a submission number |
What descends from it? (460)
See all 4603 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, K974555 (Synthes (Usa), 1998) has gone furthest, with 457 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 SMF Ti Alloy Bone Screws are intended for craniofacial and
mandibular trauma and reconstruction.
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/K963546 · printed Nov 4, 2026
Cite this page
510(k) Report. “K963546: SMF Titanium (TI) Alloy Bone Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963546
Report an extraction error
Are you the manufacturer?
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