510(k) · Cleared
ClearedSynthes Sterile 3.5 MM and 4.0 MM Cannulated Screws
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · HWC Screw, Fixation, Bone
Cleared on Nov 8, 1996 after an 85-day review. The FDA summary names its predicate without a number. 1 of the 582 devices in its family, counting itself, has a Class I recall. 581 later devices descend from it.
- Decided
- Nov 8, 1996
- Review
- 85 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 0
581 later devices descend from it, 23 citing it directly. 1 of the 582 devices in this family, counting this one, has a Class I recall.
- This deviceK963192 Synthes Sterile 3.5 MM and 4.0 MM Cannulated ScrewsSynthes (Usa) · 1996
- Descendant · cites it directly · 241 of its ownK013534 Self-Countersinking Bone ScrewBiomet Orthopedics, Inc. · 2001
- Descendant · cites it directly · 220 of its ownK102343 Emerge Medical Cannulated Screw Fixation SystemEmerge Medical · 2010
- Descendant · 2 generations on · 219 of its ownK103705 Low Profile ScrewsArthrex, Inc. · 2011
- Descendant · cites it directly · 181 of its ownK021233 Aap Cannulated ScrewsAap Implantate AG · 2002
- Descendant · 2 generations on · 180 of its ownK080101 Aap Cannulated Screw and Darco Headed ScrewAap Implantate AG · 2008
Showing 5 of 581 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub7 generations on · 2021
Most influential descendants
Showing 5 of 581 · See all- K013534Self-Countersinking Bone ScrewBiomet Orthopedics, Inc. · 2001 · cites it directly241descendants
- K102343Emerge Medical Cannulated Screw Fixation SystemEmerge Medical · 2010 · cites it directly220descendants
- K103705Low Profile ScrewsArthrex, Inc. · 2011 · 2 generations on219descendants
- K021233Aap Cannulated ScrewsAap Implantate AG · 2002 · cites it directly181descendants
- K080101Aap Cannulated Screw and Darco Headed ScrewAap Implantate AG · 2008 · 2 generations on180descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K963192 | Synthes Sterile 3.5 MM and 4.0 MM Cannulated Screws | Synthes (Usa) | 1996 | — |
| +1 | K013534 | Self-Countersinking Bone Screw | Biomet Orthopedics, Inc. | 2001 | — |
| +1 | K102343 | Emerge Medical Cannulated Screw Fixation System | Emerge Medical | 2010 | — |
| +2 | K103705 | Low Profile Screws | Arthrex, Inc. | 2011 | — |
| +1 | K021233 | Aap Cannulated Screws | Aap Implantate AG | 2002 | — |
| +2 | K080101 | Aap Cannulated Screw and Darco Headed Screw | Aap Implantate AG | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 4 | 0 |
| 2011 | 8 | 0 |
| 2012 | 5 | 0 |
| 2013 | 14 | 0 |
| 2014 | 13 | 0 |
| 2015 | 24 | 0 |
| 2016 | 15 | 0 |
| 2017 | 42 | 0 |
| 2018 | 12 | 0 |
| 2019 | 28 | 0 |
| 2020 | 39 | 0 |
| 2021 | 41 | 1 |
| 2022 | 56 | 0 |
| 2023 | 64 | 0 |
| 2024 | 65 | 0 |
| 2025 | 64 | 0 |
| 2026 | 76 | 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.
1 device in this family has a Class I recall. 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 HWC device
- #1 K203011 Monster Screw Systemscore 22.2 · 14 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 2.7 mm Cortex Screws Named without a submission number |
What descends from it? (581)
See all 58123 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K013534 | Self-Countersinking Bone Screw | 2001 | 241 |
| K102343 | Emerge Medical Cannulated Screw Fixation System | 2010 | 220 |
| K021233 | Aap Cannulated Screws | 2002 | 181 |
| K161616 | DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws… | 2017 | 33 |
| K060156 | Straight Plate with Angular Stability & Screw System | 2006 | 27 |
| K143394 | Acumed Small Fragment Base Set | 2015 | 18 |
| K140891 | Biomet Cannulated Screw System | 2014 | 16 |
| K112240 | Dyna Locking Cannulated Screw | 2012 | 14 |
| K082949 | Orthopediatrics Bone Screws | 2008 | 11 |
| K150693 | PHIN-FX Cannulated Lag Screw System | 2015 | 9 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 7 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K013534 (Biomet Orthopedics, Inc., 2001) has gone furthest, with 241 descendants of its own.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HWC
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HWC
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HWC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWC
2,893in 2025
MAUDE reports naming product code HWC, 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 | 35 | 77 | 25 | 669 |
| 2008 | 33 | 76 | 33 | 660 |
| 2009 | 27 | 113 | 29 | 651 |
| 2010 | 23 | 110 | 7 | 765 |
| 2011 | 35 | 88 | 12 | 1,104 |
| 2012 | 20 | 99 | 30 | 3,339 |
| 2013 | 25 | 90 | 14 | 3,850 |
| 2014 | 31 | 88 | 2 | 2,549 |
| 2015 | 41 | 85 | 5 | 2,711 |
| 2016 | 26 | 131 | 4 | 2,285 |
| 2017 | 40 | 127 | 4 | 2,561 |
| 2018 | 20 | 106 | 1 | 3,662 |
| 2019 | 30 | 108 | 5 | 5,463 |
| 2020 | 28 | 75 | 4 | 4,820 |
| 2021 | 26 | 84 | 2 | 4,446 |
| 2022 | 26 | 167 | 13 | 3,934 |
| 2023 | 24 | 104 | 0 | 3,718 |
| 2024 | 17 | 90 | 0 | 3,575 |
| 2025 | 15 | 111 | 1 | 2,893 |
| 2026 | 21 | 125 | 2 | — |
What is it indicated for?
Synthes 3.5 mm and 4.0 mm Cannulated Screws are intended for fracture fixation of small bones and small bone fragments.
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/K963192 · printed Nov 6, 2026
Cite this page
510(k) Report. “K963192: Synthes Sterile 3.5 MM and 4.0 MM Cannulated Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963192
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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