510(k) · Cleared
ClearedSynthes 7.3 MM Cannulated Slipped Capital Femoral Epiphysis Screws (Scfe)
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 Jan 11, 2010 after a 111-day review. The FDA summary names its predicate without a number. 17 later devices descend from it.
- Decided
- Jan 11, 2010
- Review
- 111 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 0
17 later devices descend from it, 1 citing it directly.
- This deviceK092909 Synthes 7.3 MM Cannulated Slipped Capital Femoral Epiphysis Screws…Synthes (Usa) · 2010
- Descendant · cites it directly · 16 of its ownK140891 Biomet Cannulated Screw SystemBiomet, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 8 of its ownK143188 3.Omm Biomet Cannulated Screw SystemBiomet Manufacturing Corp · 2014 · Recalled
- Descendant · 2 generations on · 3 of its ownK193214 WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated…Biomet, Inc. · 2020
- Descendant · 3 generations on · 3 of its ownK180808 Omni Foot Plating SystemExtremity Medical, LLC · 2018
- Descendant · 2 generations on · 2 of its ownK213199 Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw…Stryker GmbH · 2022
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K140891Biomet Cannulated Screw SystemBiomet, Inc. · 2014 · cites it directly16descendants
- K1431883.Omm Biomet Cannulated Screw SystemBiomet Manufacturing Corp · 2014 · 2 generations on8descendants
- K193214WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System…Biomet, Inc. · 2020 · 2 generations on3descendants
- K180808Omni Foot Plating SystemExtremity Medical, LLC · 2018 · 3 generations on3descendants
- K213199Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw SystemStryker GmbH · 2022 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K092909 | Synthes 7.3 MM Cannulated Slipped Capital Femoral Epiphysis Screws (Scfe) | Synthes (Usa) | 2010 | — |
| +1 | K140891 | Biomet Cannulated Screw System | Biomet, Inc. | 2014 | 5 |
| +2 | K143188 | 3.Omm Biomet Cannulated Screw System | Biomet Manufacturing Corp | 2014 | 1 |
| +2 | K193214 | WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw… | Biomet, Inc. | 2020 | — |
| +3 | K180808 | Omni Foot Plating System | Extremity Medical, LLC | 2018 | — |
| +2 | K213199 | Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw System | Stryker GmbH | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 5 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 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? (2)
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 6.5 mm Cannulated Screws Named without a submission number | |
| * | — | Synthes Washers Named without a submission number |
What descends from it? (17)
See all 171 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140891 | Biomet Cannulated Screw System | 2014 | 16 |
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, K140891 (Biomet, Inc., 2014) has gone furthest, with 16 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. 2010, 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 7.3 mm Cannulated Slipped Capital Femoral Epiphysis Screws are intended for fracture fixation of large bones and large bone fragments including femoral-neck fractures; slipped capital femoral epiphyses; tibial plateau fractures; ankle-arthrodeses; pediatric femoral neck fractures; intercondylar: femur fractures; SI joint disruptions; and subtalar arthrodeses.
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/K092909 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092909: Synthes 7.3 MM Cannulated Slipped Capital Femoral Epiphysis Screws (Scfe).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092909
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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