510(k) · Cleared
ClearedTITANEX™ MICROBEAM Screw System, TITANEX™ ARTEMIS Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vilex, LLC · HWC Screw, Fixation, Bone
Cleared on Sep 11, 2023 as substantially equivalent to K991197 (Vilex, Inc., 1999) after a 110-day review. Its family tree reaches back 1 generation to 1999. 3 later devices descend from it.
- Decided
- Sep 11, 2023
- Review
- 110 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K991197 (1999). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK991197 Vilex/Duval/Orthex Cannulated Bone Screw, Models P222-XX, S25-XX…Vilex, Inc. · 1999
- This deviceK231504 TITANEX™ MICROBEAM Screw System, TITANEX™ ARTEMIS Screw SystemVilex, LLC · 2023
- Descendant · cites it directly · 1 of its ownK250304 TITANEX Screw SystemsVilex, LLC · 2025
- Descendant · 2 generations on · 0 of its ownK260900 DYNEX® External Fixation SystemsVilex, LLC · 2026
- Descendant · cites it directly · 0 of its ownK252758 Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc. · 2025
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K991197 | Vilex/Duval/Orthex Cannulated Bone Screw, Models P222-XX, S25-XX, P227-XX… | Vilex, Inc. | 1999 | — |
| 0 (this device) | K231504 | TITANEX™ MICROBEAM Screw System, TITANEX™ ARTEMIS Screw System | Vilex, LLC | 2023 | — |
| +1 | K250304 | TITANEX Screw Systems | Vilex, LLC | 2025 | — |
| +2 | K260900 | DYNEX® External Fixation Systems | Vilex, LLC | 2026 | — |
| +1 | K252758 | Cannulated Screw and Kirschner (K wire) System | Orthonovis, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 2 | 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? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K991197 | Vilex/Duval/Orthex Cannulated Bone Screw, Models P222-XX, S25-XX, P227-XX, S30-XX…Summary page 4…I. Predicate Device Substantial equivalence for the TITANEX™ Screws is claimed to the following devices: • Vilex Cannulated Bone Screw / DuVal Cannulated Screw, K991197 (Primary Predicate) • Vilex FUZE®: Intramedullary Internal Fixation Nail, K102413 (Reference Device) IV. De… | 1999 |
| † | K102413 | Fuze: Intramedullary Internal Fixation Nail | 2011 |
What descends from it? (3)
2 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?
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 TITANEX™ MICROBEAM and TITANEX™ ARTEMIS Screw Systems are indicated for fracture fixation, osteotomies, reconstruction procedures and arthrodesis of bones in the foot and ankle.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231504 · printed Nov 5, 2026
Cite this page
510(k) Report. “K231504: TITANEX™ MICROBEAM Screw System, TITANEX™ ARTEMIS Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K231504
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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