510(k) · Cleared
Recalled · Class II · 2013Synthes 2.4 MM Cannulated Screw
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 Dec 3, 2001 after a 90-day review. The FDA summary names no predicate by number. 1 of the 712 devices in its family, counting itself, has a Class I recall. 711 later devices descend from it. It has been recalled once.
- Decided
- Dec 3, 2001
- Review
- 90 days
- Class
- Class II
- Product code
- HWC
- Recalls
- 1
- Predicates
- 0
711 later devices descend from it, 10 citing it directly. 1 of the 712 devices in this family, counting this one, has a Class I recall.
- This deviceK012945 Synthes 2.4 MM Cannulated ScrewSynthes (Usa) · 2001
- Descendant · cites it directly · 487 of its ownK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- Descendant · 2 generations on · 228 of its ownK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
- 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 · 168 of its ownK082874 Biodrive Cannulated Screw SystemBiomet Trauma · 2009
Showing 5 of 711 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub5 generations on · 2021
Most influential descendants
Showing 5 of 711 · See all- K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009 · cites it directly487descendants
- K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010 · 2 generations on228descendants
- K102343Emerge Medical Cannulated Screw Fixation SystemEmerge Medical · 2010 · cites it directly220descendants
- K103705Low Profile ScrewsArthrex, Inc. · 2011 · 2 generations on219descendants
- K082874Biodrive Cannulated Screw SystemBiomet Trauma · 2009 · cites it directly168descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K012945 | Synthes 2.4 MM Cannulated Screw | Synthes (Usa) | 2001 | — |
| +1 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| +2 | K100776 | Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System | Synthes (Usa) | 2010 | — |
| +1 | K102343 | Emerge Medical Cannulated Screw Fixation System | Emerge Medical | 2010 | — |
| +2 | K103705 | Low Profile Screws | Arthrex, Inc. | 2011 | — |
| +1 | K082874 | Biodrive Cannulated Screw System | Biomet Trauma | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 4 | 0 |
| 2011 | 9 | 0 |
| 2012 | 13 | 0 |
| 2013 | 15 | 0 |
| 2014 | 27 | 0 |
| 2015 | 32 | 0 |
| 2016 | 16 | 0 |
| 2017 | 51 | 0 |
| 2018 | 25 | 0 |
| 2019 | 34 | 0 |
| 2020 | 51 | 0 |
| 2021 | 57 | 1 |
| 2022 | 64 | 0 |
| 2023 | 64 | 0 |
| 2024 | 79 | 0 |
| 2025 | 80 | 0 |
| 2026 | 87 | 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?
The FDA summary names no predicate by number.
What descends from it? (711)
See all 71110 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | 2009 | 487 |
| K102343 | Emerge Medical Cannulated Screw Fixation System | 2010 | 220 |
| K082874 | Biodrive Cannulated Screw System | 2009 | 168 |
| K124027 | Monster Screw System | 2013 | 41 |
| K161616 | DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws… | 2017 | 33 |
| K082949 | Orthopediatrics Bone Screws | 2008 | 11 |
| K150693 | PHIN-FX Cannulated Lag Screw System | 2015 | 9 |
| K170021 | SMV Scientific Cannulated Screws | 2017 | 8 |
| K142057 | Infix Cannulated Screw System | 2015 | 1 |
| K111008 | Microware Bone Plates and Bone Screw | 2012 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 12, 2013 | Class II | Z-0890-2013 | Incorrect or no expiration date | Out of specification result - stability test failure of free available chlorine (FAC) which functions as a preservative for the hydrogel. The 13 month test result obtained was 4 ppm FAC and the stability specification is >10 ppm FAC. |
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 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K090675 (Smith & Nephew, Inc., 2009) has gone furthest, with 487 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 2.4 mm Cannulated Screw is intended for fixation of fractures and non-unions of small bones and small bone arthrodeses. Examples include, but are not limited to scaphoid and other carpal fractures, metacarpal and phalangeal fusions, osteotomies, and bunionectomies.
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/K012945 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012945: Synthes 2.4 MM Cannulated Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012945
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026