510(k) · Cleared
ClearedAperfix Interference Screw 7-12 MM X 20 MM; 7-12 MM X 25 MM; 7-12 MM X 30 MM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cayenne Medical, Inc. · HWC Screw, Fixation, Bone
Cleared on Feb 19, 2008 after a 76-day review. The FDA summary names no predicate by number. 1 later device descends from it.
- Decided
- Feb 19, 2008
- Review
- 76 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK073426 Aperfix Interference Screw 7-12 MM X 20 MM; 7-12 MM X 25 MM; 7-12 MM…Cayenne Medical, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK092381 Ibalance Akrfx Medial Opening Wedge Tibial System, Ifx Medial Peek…Ibalance Medical, Inc. · 2009
Most influential descendants
Showing 1 of 1 · See all- K092381Ibalance Akrfx Medial Opening Wedge Tibial System, Ifx Medial Peek Implant and Anchor…Ibalance Medical, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K073426 | Aperfix Interference Screw 7-12 MM X 20 MM; 7-12 MM X 25 MM; 7-12 MM X 30 MM | Cayenne Medical, Inc. | 2008 | — |
| +1 | K092381 | Ibalance Akrfx Medial Opening Wedge Tibial System, Ifx Medial Peek Implant and… | Ibalance Medical, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 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?
The FDA summary names no predicate by number.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092381 | Ibalance Akrfx Medial Opening Wedge Tibial System, Ifx Medial Peek Implant and Anchor… | 2009 | 0 |
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, K092381 (Ibalance Medical, Inc., 2009) has gone furthest, with 0 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 AperFix™ Interference Screw is intended for use with bone patellar tendon bone (BPTB) grafts to provide fixation during arthroscopic or open ACL reconstruction procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073426 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073426: Aperfix Interference Screw 7-12 MM X 20 MM; 7-12 MM X 25 MM; 7-12 MM X 30 MM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073426
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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