510(k) · Cleared
ClearedTITANEX Screw Systems
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 Mar 5, 2025 as substantially equivalent to K231504 (Vilex, LLC, 2023) and 2 other predicates after a 30-day review. Its family tree reaches back 2 generations to 1999. 1 later device descends from it.
- Decided
- Mar 5, 2025
- Review
- 30 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K991197 (1999). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK991197 Vilex/Duval/Orthex Cannulated Bone Screw, Models P222-XX, S25-XX…Vilex, Inc. · 1999
- 1 generation backK231504 TITANEX™ MICROBEAM Screw System, TITANEX™ ARTEMIS Screw SystemVilex, LLC · 2023
- This deviceK250304 TITANEX Screw SystemsVilex, LLC · 2025
- Descendant · cites it directly · 0 of its ownK260900 DYNEX® External Fixation SystemsVilex, LLC · 2026
Most influential descendants
Showing 1 of 1 · See all- K260900DYNEX® External Fixation SystemsVilex, LLC · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K991197 | Vilex/Duval/Orthex Cannulated Bone Screw, Models P222-XX, S25-XX, P227-XX… | Vilex, Inc. | 1999 | — |
| −1 | K231504 | TITANEX™ MICROBEAM Screw System, TITANEX™ ARTEMIS Screw System | Vilex, LLC | 2023 | — |
| 0 (this device) | K250304 | TITANEX Screw Systems | Vilex, LLC | 2025 | — |
| +1 | K260900 | DYNEX® External Fixation Systems | Vilex, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K231504 | TITANEX™ MICROBEAM Screw System, TITANEX™ ARTEMIS Screw SystemSummary page 5…21 CFR 807.92(a)(3) Predicate# Predicate Trade Name (Primary Predicate is listed first) Product Code I K231504 1I TITANEX MICROBEAM Screw System, TITANEX ARTEMIS seal �I H_w_c__ I K… | 2023 |
| * | K991197 | Vilex/Duval/Orthex Cannulated Bone Screw, Models P222-XX, S25-XX, P227-XX, S30-XX…Summary page 5…Product Code I K231504 1I TITANEX MICROBEAM Screw System, TITANEX ARTEMIS seal �I H_w_c__ I K991197 Vilex/ Duval/ Orthex Cannulated Bone Screw… | 1999 |
| * | K014154 | Vilex/Duval/Orthex Cannulated Bone Screw DB1 Thread, Model F25-XX-09; Vilex Solid Bone…Summary page 5…�I H_W_C ___� I K0141 54 Vilex/ Duval/ Orthex Cannulated Bone Screw Double Thread… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K260900 | DYNEX® External Fixation Systems | 2026 | 0 |
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?
- The line of descent spans 26 years and passes through 2 companies; a new generation was cleared every 24.4 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K260900 (Vilex, LLC, 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K231504.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 TITAN EX® 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/K250304 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250304: TITANEX Screw Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250304
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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