510(k) · Cleared
Recalled · Class II · 2013Aperfix Femoral Implant with Inserter, 9,10,11 MM X 35MM and X 29MM
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 Mar 4, 2009 after an 89-day review. The FDA summary names no predicate by number. 3 later devices descend from it. It has been recalled once.
- Decided
- Mar 4, 2009
- Review
- 89 days
- Class
- Class II
- Product code
- HWC
- Recalls
- 1
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK083612 Aperfix Femoral Implant with Inserter, 9,10,11 MM X 35MM and X 29MMCayenne Medical, Inc. · 2009
- Descendant · cites it directly · 2 of its ownK122463 Aperfix AM Femoral Implant with Inserter, 9X24 Aperfix AM Femoral…Cayenne Medical, Inc. · 2012
- Descendant · 2 generations on · 1 of its ownK161033 AFX™ Femoral Implant With InserterCayenne Medical, Inc. · 2016
- Descendant · 3 generations on · 0 of its ownK192428 AFX Femoral Implant with InserterCayenne Medical · 2019
Most influential descendants
Showing 3 of 3 · See all- K122463Aperfix AM Femoral Implant with Inserter, 9X24 Aperfix AM Femoral Implant with Inserter…Cayenne Medical, Inc. · 2012 · cites it directly2descendants
- K161033AFX™ Femoral Implant With InserterCayenne Medical, Inc. · 2016 · 2 generations on1descendant
- K192428AFX Femoral Implant with InserterCayenne Medical · 2019 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K083612 | Aperfix Femoral Implant with Inserter, 9,10,11 MM X 35MM and X 29MM | Cayenne Medical, Inc. | 2009 | — |
| +1 | K122463 | Aperfix AM Femoral Implant with Inserter, 9X24 Aperfix AM Femoral Implant with… | Cayenne Medical, Inc. | 2012 | — |
| +2 | K161033 | AFX™ Femoral Implant With Inserter | Cayenne Medical, Inc. | 2016 | — |
| +3 | K192428 | AFX Femoral Implant with Inserter | Cayenne Medical | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 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? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122463 | Aperfix AM Femoral Implant with Inserter, 9X24 Aperfix AM Femoral Implant with Inserter… | 2012 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 11, 2013 | Class II | Z-2422-2018 | Device Design | Potential for AperFix 24 mm implant breaking inside the drilled femoral socket. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K122463 (Cayenne Medical, Inc., 2012) has gone furthest, with 2 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. 2009, 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 Femoral Implant with Inserter is intended for use in tenodesis procedures with soft tissue grafts, utilizing either arthroscopic or open techniques. during Anterior Cruciate Ligament (ACL), Posterior Cruciate Ligament (PCL), Medial Collateral Ligament (MCL), Lateral Collateral Ligament (LCL), and Medial Patellofemoral Ligament (MPFL) reconstruction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083612 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083612: Aperfix Femoral Implant with Inserter, 9,10,11 MM X 35MM and X 29MM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083612
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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