510(k) · Cleared
ClearedArthrex Interference Screw-Rounded Head Screws, Full Threaded Screws, Sheathed Cannulated Interference Screws
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrex, Inc. · HWC Screw, Fixation, Bone
Cleared on Nov 7, 2005 after a 46-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 95 later devices descend from it.
- Decided
- Nov 7, 2005
- Review
- 46 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 0
95 later devices descend from it, 3 citing it directly.
- This deviceK052607 Arthrex Interference Screw-Rounded Head Screws, Full Threaded…Arthrex, Inc. · 2005
- Descendant · cites it directly · 93 of its ownK062466 Arthrex Interference ScrewArthrex, Inc. · 2006
- Descendant · 2 generations on · 47 of its ownK071176 Modification to: Arthrex Interference ScrewArthrex, Inc. · 2007
- Descendant · 3 generations on · 38 of its ownK151342 Arthrex SwiveLock AnchorsArthrex, Inc. · 2016
- Descendant · 4 generations on · 29 of its ownK171141 Arthrex SwiveLock AnchorsArthrex, Inc. · 2017
- Descendant · 4 generations on · 28 of its ownK180768 Arthrex SwiveLock AnchorsArthrex, Inc. · 2018
Showing 5 of 95 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 95 · See all- K062466Arthrex Interference ScrewArthrex, Inc. · 2006 · cites it directly93descendants
- K071176Modification to: Arthrex Interference ScrewArthrex, Inc. · 2007 · 2 generations on47descendants
- K151342Arthrex SwiveLock AnchorsArthrex, Inc. · 2016 · 3 generations on38descendants
- K171141Arthrex SwiveLock AnchorsArthrex, Inc. · 2017 · 4 generations on29descendants
- K180768Arthrex SwiveLock AnchorsArthrex, Inc. · 2018 · 4 generations on28descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K052607 | Arthrex Interference Screw-Rounded Head Screws, Full Threaded Screws, Sheathed… | Arthrex, Inc. | 2005 | — |
| +1 | K062466 | Arthrex Interference Screw | Arthrex, Inc. | 2006 | — |
| +2 | K071176 | Modification to: Arthrex Interference Screw | Arthrex, Inc. | 2007 | — |
| +3 | K151342 | Arthrex SwiveLock Anchors | Arthrex, Inc. | 2016 | — |
| +4 | K171141 | Arthrex SwiveLock Anchors | Arthrex, Inc. | 2017 | — |
| +4 | K180768 | Arthrex SwiveLock Anchors | Arthrex, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2009 | 5 | 0 |
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 1 | 0 |
| 2013 | 4 | 0 |
| 2014 | 5 | 0 |
| 2015 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 6 | 0 |
| 2019 | 5 | 0 |
| 2020 | 8 | 0 |
| 2021 | 5 | 0 |
| 2022 | 5 | 0 |
| 2023 | 12 | 0 |
| 2024 | 4 | 0 |
| 2025 | 10 | 0 |
| 2026 | 8 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (95)
See all 953 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, K062466 (Arthrex, Inc., 2006) has gone furthest, with 93 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.
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 | — |
https://510kreport.com/device/K052607 · printed Nov 5, 2026
Cite this page
510(k) Report. “K052607: Arthrex Interference Screw-Rounded Head Screws, Full Threaded Screws, Sheathed Cannulated Interference Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K052607
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026