510(k) · Cleared
ClearedRedemption Duo Hindfoot Nail System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vilex, LLC · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Jan 30, 2024 as substantially equivalent to K091976 (Biomet Trauma, 2009) after a 266-day review. Its family tree reaches back 1 generation to 2009. 1 later device descends from it.
- Decided
- Jan 30, 2024
- Review
- 266 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K091976 (2009). 1 later device descends from it, 1 citing it directly.
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 |
|---|---|---|---|---|---|
| −1 | K091976 | Biomet Phoenix Ankle Nail and Ankle Arthrodesis Nail | Biomet Trauma | 2009 | 2 |
| 0 (this device) | K231343 | Redemption Duo Hindfoot Nail System | Vilex, LLC | 2024 | — |
| +1 | K260900 | DYNEX® External Fixation Systems | Vilex, LLC | 2026 | — |
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 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? (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 |
|---|---|---|---|
| * | K091976 | Biomet Phoenix Ankle Nail and Ankle Arthrodesis NailSummary page 4…ion Duo Hindfoot Nail System Vilex HSB Device Primary Biomet Phoenix Ankle Nail and Ankle Zimmer K091976 HSB Predicate Arthrodesis Nail… | 2009 |
| † | K221031 | Arthrex DualCompression Hindfoot Fusion Nail Implant System | 2022 |
| † | K051678 | Synthes Hindfoot Arthrodesis Nail System | 2005 |
| † | K173811 | TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis System | 2018 |
| † | K102413 | Fuze: Intramedullary Internal Fixation Nail | 2011 |
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?
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. 2024, 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 Redemption Duo Hindfoot Nail System is intended for tibiotalocalcaneal arthrodesis (fusion) Specific indications include: • Post-traumatic or degenerative arthritis • Previously infected arthrosis • Revision ankle arthrodesis • Failed total ankle arthroplasty • Avascular necrosis of the talus • Severe deformity or instability as a result of talipes equinovarus, cerebral vascular accident, paralysis or other neuromuscular disease • Rheumatoid…
Read the full statement (94 words)
The Vilex Redemption Duo Hindfoot Nail System is intended for tibiotalocalcaneal arthrodesis (fusion)
Specific indications include:
• Post-traumatic or degenerative arthritis
• Previously infected arthrosis
• Revision ankle arthrodesis
• Failed total ankle arthroplasty
• Avascular necrosis of the talus
• Severe deformity or instability as a result of talipes equinovarus, cerebral vascular accident, paralysis or other neuromuscular disease
• Rheumatoid arthritis
• Osteoarthritis
• Pseudarthrosis
• Trauma (malunited tibial pilon fracture)
• Charcot foot
• Severe endstage degenerative arthritis
• Severe defects after tumor resection
• Pantalar arthrodesis
• Post-traumatic arthrosis
• Neuroarthropathy
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231343 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231343: Redemption Duo Hindfoot Nail System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231343
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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