510(k) · Cleared
ClearedSynthes 4.5 MM and 6.5 MM Headless Compression 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 Apr 23, 2008 after a 20-day review. The FDA summary names its predicate without a number. 1 of the 216 devices in its family, counting itself, has a Class I recall. 215 later devices descend from it.
- Decided
- Apr 23, 2008
- Review
- 20 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 0
215 later devices descend from it, 10 citing it directly. 1 of the 216 devices in this family, counting this one, has a Class I recall.
- This deviceK080943 Synthes 4.5 MM and 6.5 MM Headless Compression ScrewsSynthes (Usa) · 2008
- Descendant · cites it directly · 161 of its ownK111994 Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011
- Descendant · 2 generations on · 79 of its ownK143039 CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem · 2015
- Descendant · 2 generations on · 74 of its ownK162825 CAPTIVATE™ Compression ScrewsGlobus Medical, Inc. · 2017
- Descendant · 3 generations on · 69 of its ownK171651 Excelsius GPSGlobus Medical, Inc. · 2017 · Recalled
- Descendant · 4 generations on · 42 of its ownK191100 ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc. · 2019
Showing 5 of 215 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub4 generations on · 2021
Most influential descendants
Showing 5 of 215 · See all- K111994Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011 · cites it directly161descendants
- K143039CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem · 2015 · 2 generations on79descendants
- K162825CAPTIVATE™ Compression ScrewsGlobus Medical, Inc. · 2017 · 2 generations on74descendants
- K171651Excelsius GPSGlobus Medical, Inc. · 2017 · 3 generations on69descendants
- K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc. · 2019 · 4 generations on42descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K080943 | Synthes 4.5 MM and 6.5 MM Headless Compression Screws | Synthes (Usa) | 2008 | — |
| +1 | K111994 | Smith & Nephew Cannulated Screws and Washers | Smith & Nephew, Inc. | 2011 | — |
| +2 | K143039 | CrossRoads Screw System | Orthodiscovery Group, LLC (D.B.A. Crossroads Extrem | 2015 | — |
| +2 | K162825 | CAPTIVATE™ Compression Screws | Globus Medical, Inc. | 2017 | — |
| +3 | K171651 | Excelsius GPS | Globus Medical, Inc. | 2017 | 1 |
| +4 | K191100 | ExcelsiusGPS Spine 1.1 Interbody Module | Globus Medical, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 4 | 0 |
| 2014 | 3 | 0 |
| 2015 | 10 | 0 |
| 2016 | 5 | 0 |
| 2017 | 12 | 0 |
| 2018 | 3 | 0 |
| 2019 | 10 | 0 |
| 2020 | 15 | 0 |
| 2021 | 15 | 1 |
| 2022 | 19 | 0 |
| 2023 | 26 | 0 |
| 2024 | 30 | 0 |
| 2025 | 24 | 0 |
| 2026 | 38 | 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? (3)
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 4.5 mm Cannulated Screws Named without a submission number | |
| * | — | Synthes 6.5 mm Cannulated Screws Named without a submission number | |
| * | — | OsteoMed's Headless Cannulated Screw System Named without a submission number |
What descends from it? (215)
See all 21510 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111994 | Smith & Nephew Cannulated Screws and Washers | 2011 | 161 |
| K161616 | DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws… | 2017 | 33 |
| K133460 | Aptus Cannulated Compression Screws | 2013 | 8 |
| K143165 | Herbert/Whipple Bone Screw System, Herbert/Whipple Bone Screw System, Herbert Cannulated… | 2015 | 7 |
| K161894 | SurgTech Trauma System | 2017 | 3 |
| K133451 | Fixos Screw System | 2014 | 3 |
| K131324 | Maxtorque Screw System | 2013 | 2 |
| K190830 | TDM Screw Systems | 2019 | 1 |
| K132248 | Flower Bone Screw Set | 2013 | 1 |
| K210146 | Cannulated Compression Device System | 2022 | 0 |
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 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K111994 (Smith & Nephew, Inc., 2011) has gone furthest, with 161 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. 2008, 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 4.5 mm and 6.5 mm Headless Compression Screws are indicated for fracture fixation, reconstruction, osteotomy, and arthrodesis of various bones and bone fragments including joint fusions (arthrodeses) in the foot and fixation of intra-articular fractures of the humerus, femur and tibia.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080943 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080943: Synthes 4.5 MM and 6.5 MM Headless Compression Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080943
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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