510(k) · Cleared
ClearedVilex Bone Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vilex, Inc. · HWC Screw, Fixation, Bone
Cleared on Aug 5, 2004 after an 84-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 7 later devices descend from it.
- Decided
- Aug 5, 2004
- Review
- 84 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 4 citing it directly.
- This deviceK041287 Vilex Bone Plate SystemVilex, Inc. · 2004
- Descendant · cites it directly · 3 of its ownK212348 ALPHALOK™ Plating SystemVilex, LLC · 2022
- Descendant · 2 generations on · 2 of its ownK221558 ALPHALOK Plating SystemVilex, LLC · 2022
- Descendant · cites it directly · 1 of its ownK200108 GEO 1st MTP Joint Arthrodesis Plating SystemGramercy Extremity Orthopedics, LLC · 2020 · Recalled
- Descendant · 3 generations on · 0 of its ownK233816 REDEMPTION Charcot Plating SystemVilex, LLC · 2024
- Descendant · 2 generations on · 0 of its ownK230204 ALPHALOK Plating SystemVilex, LLC · 2023
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K212348ALPHALOK™ Plating SystemVilex, LLC · 2022 · cites it directly3descendants
- K221558ALPHALOK Plating SystemVilex, LLC · 2022 · 2 generations on2descendants
- K200108GEO 1st MTP Joint Arthrodesis Plating SystemGramercy Extremity Orthopedics, LLC · 2020 · cites it directly1descendant
- K233816REDEMPTION Charcot Plating SystemVilex, LLC · 2024 · 3 generations on0descendants
- K230204ALPHALOK Plating SystemVilex, LLC · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K041287 | Vilex Bone Plate System | Vilex, Inc. | 2004 | — |
| +1 | K212348 | ALPHALOK™ Plating System | Vilex, LLC | 2022 | — |
| +2 | K221558 | ALPHALOK Plating System | Vilex, LLC | 2022 | — |
| +1 | K200108 | GEO 1st MTP Joint Arthrodesis Plating System | Gramercy Extremity Orthopedics, LLC | 2020 | 1 |
| +3 | K233816 | REDEMPTION Charcot Plating System | Vilex, LLC | 2024 | — |
| +2 | K230204 | ALPHALOK Plating System | Vilex, LLC | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (7)
4 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, K212348 (Vilex, LLC, 2022) 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.
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 Vilex Bone Plates have the following Indications for Use: Small-Bone Fracture and Osteotomy in Upper & Lower Extremities, primarily hand, foot, and digits.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K041287 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041287: Vilex Bone Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041287
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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