510(k) · Cleared
ClearedSynthes 3.5MM Low Profile Cortical Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (USA) Products, LLC · HWC Screw, Fixation, Bone
Cleared on May 24, 2011 as substantially equivalent to K043185 (Synthes (Usa), 2005) after a 22-day review. Its family tree reaches back 1 generation to 2005. 122 later devices descend from it.
- Decided
- May 24, 2011
- Review
- 22 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K043185 (2005). 122 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK043185 Synthes 3.5MM Cortex ScrewsSynthes (Usa) · 2005
- This deviceK111230 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 · 44 of its ownK120854 Synthes VA LCP Ankle Trauma SystemSynthes USA · 2012
- Descendant · 2 generations on · 33 of its ownK161616 DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm…Synthes USA Products, LLC · 2017
- Descendant · 3 generations on · 23 of its ownK143385 Acumed Ankle Plating SystemAcumed, LLC · 2015
- Descendant · 4 generations on · 15 of its ownK151886 Acumed Ankle and Small Fragment Base Set UpdateAcumed, LLC · 2015
Showing 5 of 122 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 122 · See all- K112583Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011 · cites it directly118descendants
- K120854Synthes VA LCP Ankle Trauma SystemSynthes USA · 2012 · 2 generations on44descendants
- K161616DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws…Synthes USA Products, LLC · 2017 · 2 generations on33descendants
- K143385Acumed Ankle Plating SystemAcumed, LLC · 2015 · 3 generations on23descendants
- K151886Acumed Ankle and Small Fragment Base Set UpdateAcumed, LLC · 2015 · 4 generations on15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K043185 | Synthes 3.5MM Cortex Screws | Synthes (Usa) | 2005 | — |
| 0 (this device) | K111230 | Synthes 3.5MM Low Profile Cortical Screw | Synthes (USA) Products, LLC | 2011 | — |
| +1 | K112583 | Synthes Cortical Screws | Synthes (USA) Products, LLC | 2011 | — |
| +2 | K120854 | Synthes VA LCP Ankle Trauma System | Synthes USA | 2012 | — |
| +2 | K161616 | DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated… | Synthes USA Products, LLC | 2017 | — |
| +3 | K143385 | Acumed Ankle Plating System | Acumed, LLC | 2015 | — |
| +4 | K151886 | Acumed Ankle and Small Fragment Base Set Update | Acumed, LLC | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 7 | 0 |
| 2016 | 4 | 0 |
| 2017 | 7 | 0 |
| 2018 | 5 | 0 |
| 2019 | 8 | 0 |
| 2020 | 9 | 0 |
| 2021 | 13 | 0 |
| 2022 | 9 | 0 |
| 2023 | 8 | 0 |
| 2024 | 16 | 0 |
| 2025 | 11 | 0 |
| 2026 | 18 | 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 |
|---|---|---|---|
| * | K043185 | Synthes 3.5MM Cortex ScrewsSummary page 1…h or Threaded Metallic Bone Fixation Fastener Product Code: 1-WC Predicate Synthes 3.5mm Cortex Screws (K043185) Device(s): Device Description: The 3.5mm Low Profile Cortical Screws are self-tapping, have ei… | 2005 |
What descends from it? (122)
See all 1223 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?
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
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 3.5mm Low Profile Contical 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 in adults, and in both children (2-12 years) and adolescents (12-21 years) in which grow~h plates have fused or in which growth plates will not be crossed by the screw fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111230 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111230: Synthes 3.5MM Low Profile Cortical Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111230
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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