510(k) · Cleared
ClearedSynthes 3.5MM Cortex 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 Feb 3, 2005 after a 78-day review. The FDA summary names its predicate without a number. 405 later devices descend from it.
- Decided
- Feb 3, 2005
- Review
- 78 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 0
405 later devices descend from it, 20 citing it directly.
- This deviceK043185 Synthes 3.5MM Cortex ScrewsSynthes (Usa) · 2005
- Descendant · cites it directly · 219 of its ownK103705 Low Profile ScrewsArthrex, Inc. · 2011
- Descendant · 2 generations on · 135 of its ownK111253 Arthrex Distal Extremity Plate SystemArthrex, Inc. · 2011
- Descendant · cites it directly · 122 of its ownK111230 Synthes 3.5MM Low Profile Cortical ScrewSynthes (USA) Products, LLC · 2011
- Descendant · cites it directly · 118 of its ownK112583 Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011
- Descendant · 2 generations on · 91 of its ownK112437 Arthrex Fracture SystemArthrex, Inc. · 2011
Showing 5 of 405 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 405 · See all- K103705Low Profile ScrewsArthrex, Inc. · 2011 · cites it directly219descendants
- K111253Arthrex Distal Extremity Plate SystemArthrex, Inc. · 2011 · 2 generations on135descendants
- K111230Synthes 3.5MM Low Profile Cortical ScrewSynthes (USA) Products, LLC · 2011 · cites it directly122descendants
- K112583Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011 · cites it directly118descendants
- K112437Arthrex Fracture SystemArthrex, Inc. · 2011 · 2 generations on91descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K043185 | Synthes 3.5MM Cortex Screws | Synthes (Usa) | 2005 | — |
| +1 | K103705 | Low Profile Screws | Arthrex, Inc. | 2011 | — |
| +2 | K111253 | Arthrex Distal Extremity Plate System | Arthrex, Inc. | 2011 | — |
| +1 | K111230 | Synthes 3.5MM Low Profile Cortical Screw | Synthes (USA) Products, LLC | 2011 | — |
| +1 | K112583 | Synthes Cortical Screws | Synthes (USA) Products, LLC | 2011 | — |
| +2 | K112437 | Arthrex Fracture System | Arthrex, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 11 | 0 |
| 2012 | 6 | 0 |
| 2013 | 10 | 0 |
| 2014 | 20 | 0 |
| 2015 | 25 | 0 |
| 2016 | 14 | 0 |
| 2017 | 33 | 0 |
| 2018 | 16 | 0 |
| 2019 | 22 | 0 |
| 2020 | 30 | 0 |
| 2021 | 27 | 0 |
| 2022 | 31 | 0 |
| 2023 | 31 | 0 |
| 2024 | 41 | 0 |
| 2025 | 36 | 0 |
| 2026 | 43 | 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 HWC? 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 3.5 mm Cortex Screws Named without a submission number |
What descends from it? (405)
See all 40520 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103705 | Low Profile Screws | 2011 | 219 |
| K111230 | Synthes 3.5MM Low Profile Cortical Screw | 2011 | 122 |
| K112583 | Synthes Cortical Screws | 2011 | 118 |
| K082516 | Peri-Loc Periarticular Locked Plating System Hexalobular Bone Screws | 2008 | 87 |
| K062494 | Ebi Optilock Upper Extremity Plating System | 2006 | 22 |
| K113733 | Small and Large Fragments Osteosynthesis System Neofix | 2012 | 11 |
| K082949 | Orthopediatrics Bone Screws | 2008 | 11 |
| K161665 | VLP Wrist Fracture System | 2016 | 10 |
| K181533 | EVOS Wrist Fracture Plating System | 2018 | 9 |
| K130108 | Double Engine Bone Plate and Screw Systems | 2013 | 9 |
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, K103705 (Arthrex, Inc., 2011) has gone furthest, with 219 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?
The Synthes 3.5 mm Cortex Screws are intended for fixation of fractures, osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, calcaneous, femur and fibula.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043185 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043185: Synthes 3.5MM Cortex Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043185
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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