510(k) · Cleared
ClearedValor (R) Ankle Fusion Nail System Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wrightmedicaltechnologyinc · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Mar 23, 2011 as substantially equivalent to K090857 (Wrightmedicaltechnologyinc, 2009) after a 23-day review. Its family tree reaches back 1 generation to 2009. 3 later devices descend from it.
- Decided
- Mar 23, 2011
- Review
- 23 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K090857 (2009). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK090857 Valor Ankle Fusion Nail SystemWrightmedicaltechnologyinc · 2009 · Recalled
- This deviceK110552 Valor (R) Ankle Fusion Nail System ScrewWrightmedicaltechnologyinc · 2011
- Descendant · cites it directly · 1 of its ownK121575 Oxford Ankle Fusion Nail (Afn) SystemOrtho Solutions Limited · 2012 · Recalled
- Descendant · 2 generations on · 0 of its ownK250622 Succession™ AFN SystemOrtho Solutions UK, Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK102577 Force Medical IM Nail SystemForce Medical, Inc. · 2012
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 | K090857 | Valor Ankle Fusion Nail System | Wrightmedicaltechnologyinc | 2009 | 5 |
| 0 (this device) | K110552 | Valor (R) Ankle Fusion Nail System Screw | Wrightmedicaltechnologyinc | 2011 | — |
| +1 | K121575 | Oxford Ankle Fusion Nail (Afn) System | Ortho Solutions Limited | 2012 | 1 |
| +2 | K250622 | Succession™ AFN System | Ortho Solutions UK, Ltd. | 2025 | — |
| +1 | K102577 | Force Medical IM Nail System | Force Medical, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K090857 | Valor Ankle Fusion Nail SystemSummary page 1…rainedullary and Accessories 87 Orthopedics A.3. Predicate Device: VALOR®P Ankle Fusion Nail System (K090857) A.4. Device Description The VALOR®Lt Ankle Fusion Nail System - Extended Screw Lengths are a line extension to the exi… | 2009 |
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 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 VALOR® Ankle Fusion Nail System is intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instability, and skeletal defects after tumor resection. These include Neuro-osteoarthropathy (Charcot's Foot), Avascular Necrosis of the talus, failed joint replacement, failed ankle fusion, distal tibia fracture non-unions, Osteoarthritis, Rheumatoid Arthritis, and Pseudoarthrosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110552 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110552: Valor (R) Ankle Fusion Nail System Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110552
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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