510(k) Report

510(k) · Cleared

Recalled · Class II · 2018

Valor Ankle Fusion Nail System

K090857510(k) TraditionalCleared Jul 14, 2009106-day reviewClass II21 CFR 888.3020Recalls 5

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Wrightmedicaltechnologyinc · HSB Rod, Fixation, Intramedullary And Accessories

Cleared on Jul 14, 2009 after a 106-day review. The FDA summary names no predicate by number. 24 later devices descend from it. It has been recalled 5 times.

Decided
Jul 14, 2009
Review
106 days
Class
Class II
Product code
HSB
Recalls
5
Predicates
0

24 later devices descend from it, 7 citing it directly.

Descendants, by year cleared 2013: 2 descendants cleared2011: 2 descendants cleared2012: 2 descendants cleared2014: 1 descendant cleared2022: 1 descendant cleared2024: 2 descendants cleared2019: 2 descendants cleared2025: 3 descendants cleared2015: 1 descendant cleared2017: 2 descendants cleared2016: 1 descendant cleared2023: 1 descendant cleared2020: 2 descendants cleared2021: 1 descendant cleared2026: 1 descendant cleared20052010201520202025
  1. This deviceK090857 Valor Ankle Fusion Nail SystemWrightmedicaltechnologyinc · 2009
  2. Descendant · cites it directly · 14 of its ownK123810 Piccolo Composite Ankle Arthrodesis Nailing SystemCarboFix Orthopedics, Ltd. · 2013
  3. Descendant · 2 generations on · 8 of its ownK182307 Small Bone Phantom® Intramedullary Nail System; TTC Phantom®…Paragon 28, Inc. · 2019
  4. Descendant · cites it directly · 7 of its ownK102413 Fuze: Intramedullary Internal Fixation NailVilex, Inc. · 2011 · Recalled
  5. Descendant · 3 generations on · 6 of its ownK192163 TTC Phantom® Intramedullary Nail SystemParagon 28, Inc. · 2020
  6. Descendant · 2 generations on · 6 of its ownK191782 TTC Phantom Intramedullary Nail SystemParagon 28, Inc. · 2019

Showing 5 of 24 descendants. See all descendants

Descendants cleared per year

2011: 22012: 22013: 22014: 12015: 12016: 12017: 22019: 22020: 22021: 12022: 12023: 12024: 22025: 32026: 1
2011high 3 (2025) · low 0 (2018)2026

Most influential descendants

Showing 5 of 24 · See all
  • K123810Piccolo Composite Ankle Arthrodesis Nailing SystemCarboFix Orthopedics, Ltd. · 2013 · cites it directly14descendants
  • K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc. · 2019 · 2 generations on8descendants
  • K102413Fuze: Intramedullary Internal Fixation NailVilex, Inc. · 2011 · cites it directly7descendants
  • K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc. · 2020 · 3 generations on6descendants
  • K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc. · 2019 · 2 generations on6descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K090857Valor Ankle Fusion Nail SystemWrightmedicaltechnologyinc2009—
+1K123810Piccolo Composite Ankle Arthrodesis Nailing SystemCarboFix Orthopedics, Ltd.2013—
+2K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary…Paragon 28, Inc.2019—
+1K102413Fuze: Intramedullary Internal Fixation NailVilex, Inc.20113
+3K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.2020—
+2K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.2019—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201120
201220
201320
201410
201510
201610
201720
201920
202020
202110
202210
202310
202420
202530
202610
FIG. 1 — Lineage of K090857, 2009–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K200869 Gamma3 Systemscore 19.8 · 8 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (24)

See all 24

7 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K123810Piccolo Composite Ankle Arthrodesis Nailing SystemCarboFix Orthopedics, Ltd.201314
K102413Fuze: Intramedullary Internal Fixation NailVilex, Inc.20117
K110552Valor (R) Ankle Fusion Nail System ScrewWrightmedicaltechnologyinc20113
K230088Ankle Truss System (ATS)4Web Medical, Inc.20241
K142602VALOR Hindfoot Fusion Nail SystemWrightmedicaltechnologyinc20141
K121575Oxford Ankle Fusion Nail (Afn) SystemOrtho Solutions Limited20121
K221031Arthrex DualCompression Hindfoot Fusion Nail Implant SystemArthrex, Inc.20220

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Mar 14, 2018Class IIZ-1376-2018Under Investigation by firmTow lot of VALOR(TM) Nail could potentially be missing the assembled compression screw.
Mar 14, 2018Class IIZ-1375-2018Under Investigation by firmTow lot of VALOR(TM) Nail could potentially be missing the assembled compression screw.
Nov 8, 2016Class IIZ-0566-2020Process controlThe firm discovered a lack of adequate documentation confirming sterility on certain products.
Apr 5, 2012Not classifiedZ-1484-2012Device DesignThe possibility exists that the handle of the targeting guide may rotate and/or break under normal usage.
Apr 5, 2012Not classifiedZ-1485-2012Device DesignThe possibility exists that the handle of the targeting guide may rotate and/or break under normal usage.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K123810 (CarboFix Orthopedics, Ltd., 2013) has gone furthest, with 14 descendants of its own.

How does its category compare?

All HSB devices

HSB Rod, Fixation, Intramedullary And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · HSB

15in 2025

2007: 82008: 112009: 182010: 142011: 162012: 172013: 182014: 192015: 222016: 82017: 232018: 172019: 132020: 172021: 102022: 122023: 112024: 132025: 152026 (partial year): 18
2007high 23 (2017) · low 8 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HSB

106in 2025

2007: 68 days median2008: 57 days median2009: 86 days median2010: 117 days median2011: 78 days median2012: 112 days median2013: 105 days median2014: 147 days median2015: 111 days median2016: 124 days median2017: 119 days median2018: 134 days median2019: 132 days median2020: 112 days median2021: 94 days median2022: 172 days median2023: 162 days median2024: 195 days median2025: 106 days median2026 (partial year): 151 days median
2007high 195 (2024) · low 57 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HSB

18in 2025

2008: 92009: 812010: 182011: 22012: 72013: 142014: 32015: 32016: 62017: 662018: 562019: 62020: 62021: 22022: 12023: 12024: 12025: 182026 (partial year): 1
2007high 81 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HSB

2,911in 2025

2007: 1622008: 1842009: 3342010: 4542011: 6622012: 1,0792013: 1,7732014: 1,4742015: 1,6712016: 1,9202017: 1,4472018: 3,5262019: 2,5172020: 3,2992021: 4,1112022: 2,7332023: 2,2192024: 2,8692025: 2,911
2007high 4,111 (2021) · low 162 (2007)2025

MAUDE reports naming product code HSB, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20078680162
200811579184
2009188681334
20101411718454
201116782662
20121711271,079
201318105141,773
20141914731,474
20152211131,671
2016812461,920
201723119661,447
201817134563,526
20191313262,517
20201711263,299
2021109424,111
20221217212,733
20231116212,219
20241319512,869
202515106182,911
2026181511—

What is it indicated for?

The VALORTM 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.

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The HSB category page

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https://510kreport.com/device/K090857 · printed Nov 4, 2026

Cite this page

510(k) Report. “K090857: Valor Ankle Fusion Nail System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090857

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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