510(k) · Cleared
Recalled · Class II · 2015Fuze: Intramedullary Internal Fixation Nail
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vilex, Inc. · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Nov 14, 2011 as substantially equivalent to K090857 (Wrightmedicaltechnologyinc, 2009) and 4 other predicates after a 447-day review. Its family tree reaches back 4 generations to 1998. 7 later devices descend from it. It has been recalled 3 times.
- Decided
- Nov 14, 2011
- Review
- 447 days
- Class
- Class II
- Product code
- HSB
- Recalls
- 3
- Predicates
- 5
Its longest line of descent runs back 4 generations to K982953 (1998). 13 ancestors in all, the oldest K950394 (1995). 7 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK982953 Titanium Intramedullary Nails-Various StylesBiomet, Inc. · 1998 · Recalled
- 3 generations backK021786 Titanium Ankle Arthrodesis NailBiomet, Inc. · 2002 · Recalled
- 2 generations backK050882 Newdeal Ankle NailNew Deal, S.A. · 2005 · Recalled
- 1 generation backK091788 Panta Nail (Dia. 10MM), Panta Nail XLNewdeal Sas · 2009 · Recalled
- This deviceK102413 Fuze: Intramedullary Internal Fixation NailVilex, Inc. · 2011
- Descendant · cites it directly · 6 of its ownK191782 TTC Phantom Intramedullary Nail SystemParagon 28, Inc. · 2019
- Descendant · 2 generations on · 5 of its ownK201227 Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc. · 2020
- Descendant · 3 generations on · 2 of its ownK210869 Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc. · 2021 · Recalled
- Descendant · 2 generations on · 1 of its ownK251850 Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc. · 2025
- Descendant · 4 generations on · 1 of its ownK231231 MR Safety and Compatibility Testing and Labeling for Paragon 28…Paragon 28, Inc. · 2023
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc. · 2019 · cites it directly6descendants
- K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc. · 2020 · 2 generations on5descendants
- K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc. · 2021 · 3 generations on2descendants
- K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc. · 2025 · 2 generations on1descendant
- K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc. · 2023 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K982953 | Titanium Intramedullary Nails-Various Styles | Biomet, Inc. | 1998 | 4 |
| −3 | K021786 | Titanium Ankle Arthrodesis Nail | Biomet, Inc. | 2002 | 1 |
| −2 | K050882 | Newdeal Ankle Nail | New Deal, S.A. | 2005 | 5 |
| −1 | K091788 | Panta Nail (Dia. 10MM), Panta Nail XL | Newdeal Sas | 2009 | 2 |
| 0 (this device) | K102413 | Fuze: Intramedullary Internal Fixation Nail | Vilex, Inc. | 2011 | — |
| +1 | K191782 | TTC Phantom Intramedullary Nail System | Paragon 28, Inc. | 2019 | — |
| +2 | K201227 | Phantom® Hindfoot TTC/TC Nail System | Paragon 28, Inc. | 2020 | — |
| +3 | K210869 | Phantom Hindfoot TTC/TC Nail System | Paragon 28, Inc. | 2021 | 3 |
| +2 | K251850 | Phantom® Hindfoot TTC/TC Nail System | Paragon 28, Inc. | 2025 | — |
| +4 | K231231 | MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic… | Paragon 28, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 HSB? 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 HSB device
- #1 K200869 Gamma3 Systemscore 19.8 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K090857 | Valor Ankle Fusion Nail SystemSummary page 1…CFR 888.3030 Single/Multiple component metallic bone fixation appliances and accessories; Product Code HSB, Class 11 Predicate Devices: K090857 Ankle Fusion Nail (VALORM) K02 1786 Titanium Ankle Arthrodesis Nail (Phoe… | 2009 |
| * | K021786 | Titanium Ankle Arthrodesis NailSummary page 1…ces and accessories; Product Code HSB, Class 11 Predicate Devices: K090857 Ankle Fusion Nail (VALORM) K02 1786 Titanium Ankle Arthrodesis Nail (Phoenix) K043052 TriGen Hindfoot Fusion… | 2002 |
| * | K043052 | Trigen Hindfoot Fusion NailSummary page 1…K090857 Ankle Fusion Nail (VALORM) K02 1786 Titanium Ankle Arthrodesis Nail (Phoenix) K043052 TriGen Hindfoot Fusion Nail K05 1590 T2 Ankle Arthrodesis Nail… | 2004 |
| * | K051590 | T2 Ankle Arthrodesis NailSummary page 1…K02 1786 Titanium Ankle Arthrodesis Nail (Phoenix) K043052 TriGen Hindfoot Fusion Nail K05 1590 T2 Ankle Arthrodesis Nail K09 1788 Panta Arthrodesis Nail… | 2005 |
| * | K091788 | Panta Nail (Dia. 10MM), Panta Nail XLSummary page 1…K043052 TriGen Hindfoot Fusion Nail K05 1590 T2 Ankle Arthrodesis Nail K09 1788 Panta Arthrodesis Nail The Vilex FUZEIM is a single-piece intramedullary nail fixed to t… | 2009 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191782 | TTC Phantom Intramedullary Nail System | 2019 | 6 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 22, 2015 | Class II | Z-1721-2015 | Device Design | Incidence of breakage is higher than expected. |
| Apr 22, 2015 | Class II | Z-1723-2015 | Device Design | Incidence of breakage is higher than expected. |
| Apr 22, 2015 | Class II | Z-1722-2015 | Device Design | Incidence of breakage is higher than expected. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 3.8 years on median.
- 7 of the 13 ancestors have a recall of any class.
- Of its descendants, K191782 (Paragon 28, Inc., 2019) has gone furthest, with 6 descendants of its own.
- 6 other devices also cite its predicate K090857.
How does its category compare?
All HSB devicesHSB Rod, Fixation, Intramedullary And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · HSB
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HSB
106in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HSB
18in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HSB
2,911in 2025
MAUDE reports naming product code HSB, 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 | 8 | 68 | 0 | 162 |
| 2008 | 11 | 57 | 9 | 184 |
| 2009 | 18 | 86 | 81 | 334 |
| 2010 | 14 | 117 | 18 | 454 |
| 2011 | 16 | 78 | 2 | 662 |
| 2012 | 17 | 112 | 7 | 1,079 |
| 2013 | 18 | 105 | 14 | 1,773 |
| 2014 | 19 | 147 | 3 | 1,474 |
| 2015 | 22 | 111 | 3 | 1,671 |
| 2016 | 8 | 124 | 6 | 1,920 |
| 2017 | 23 | 119 | 66 | 1,447 |
| 2018 | 17 | 134 | 56 | 3,526 |
| 2019 | 13 | 132 | 6 | 2,517 |
| 2020 | 17 | 112 | 6 | 3,299 |
| 2021 | 10 | 94 | 2 | 4,111 |
| 2022 | 12 | 172 | 1 | 2,733 |
| 2023 | 11 | 162 | 1 | 2,219 |
| 2024 | 13 | 195 | 1 | 2,869 |
| 2025 | 15 | 106 | 18 | 2,911 |
| 2026 | 18 | 151 | 1 | — |
What is it indicated for?
The Vilex FUZE has the following Indications for Use
Ankle Arthordesis, Tiblo-talo-calacaneal Arthrodesis
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102413 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102413: Fuze: Intramedullary Internal Fixation Nail.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102413
Report an extraction error
Are you the manufacturer?
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