510(k) · Cleared
ClearedAperfix Implant with Inserter, 8, 9, 10, 11, MM X30 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 Mar 4, 2009 after an 89-day review. The FDA summary names no predicate by number. 7 later devices descend from it.
- Decided
- Mar 4, 2009
- Review
- 89 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 3 citing it directly.
- This deviceK083607 Aperfix Implant with Inserter, 8, 9, 10, 11, MM X30 MMCayenne Medical, Inc. · 2009
- Descendant · cites it directly · 3 of its ownK093912 Arthrex Tibial GraftboltArthrex, Inc. · 2010
- Descendant · 2 generations on · 2 of its ownK103060 Arthrex Tibial GraftboltArthrex, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK103145 Hammerloc TM Tibial Fixation DeviceBiomet Sports Medicine · 2011 · Recalled
- Descendant · 3 generations on · 0 of its ownK253130 Dione PEEK Screw SystemZheJiang Decans Medical Devices Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK193092 TunneLoc Tibial Fixation DeviceBiomet, Inc. · 2020
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K093912Arthrex Tibial GraftboltArthrex, Inc. · 2010 · cites it directly3descendants
- K103060Arthrex Tibial GraftboltArthrex, Inc. · 2011 · 2 generations on2descendants
- K103145Hammerloc TM Tibial Fixation DeviceBiomet Sports Medicine · 2011 · cites it directly1descendant
- K253130Dione PEEK Screw SystemZheJiang Decans Medical Devices Co., Ltd. · 2026 · 3 generations on0descendants
- K193092TunneLoc Tibial Fixation DeviceBiomet, Inc. · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K083607 | Aperfix Implant with Inserter, 8, 9, 10, 11, MM X30 MM | Cayenne Medical, Inc. | 2009 | — |
| +1 | K093912 | Arthrex Tibial Graftbolt | Arthrex, Inc. | 2010 | — |
| +2 | K103060 | Arthrex Tibial Graftbolt | Arthrex, Inc. | 2011 | — |
| +1 | K103145 | Hammerloc TM Tibial Fixation Device | Biomet Sports Medicine | 2011 | 2 |
| +3 | K253130 | Dione PEEK Screw System | ZheJiang Decans Medical Devices Co., Ltd. | 2026 | — |
| +2 | K193092 | TunneLoc Tibial Fixation Device | Biomet, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2020 | 1 | 0 |
| 2026 | 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? (7)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K093912 (Arthrex, Inc., 2010) has gone furthest, with 3 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 Tibial 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/K083607 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083607: Aperfix Implant with Inserter, 8, 9, 10, 11, MM X30 MM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083607
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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