510(k) Report

510(k) · Cleared

Cleared

Arthrex DualCompression Hindfoot Fusion Nail Implant System

K221031510(k) TraditionalCleared Dec 20, 2022257-day reviewClass II21 CFR 888.3020

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

Arthrex, Inc. · HSB Rod, Fixation, Intramedullary And Accessories

Cleared on Dec 20, 2022 as substantially equivalent to K090857 (Wrightmedicaltechnologyinc, 2009) and 3 other predicates after a 257-day review. Its family tree reaches back 5 generations to 1998.

Decided
Dec 20, 2022
Review
257 days
Class
Class II
Product code
HSB
Recalls
None
Predicates
4

Its longest line of descent runs back 5 generations to K974781 (1998). 11 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2014: 1 other ancestor2009: 1 other ancestor2000: 1 other ancestor1999: 1 other ancestor1998: 2 other ancestorsK974781 · Depuy Ace Aim (R) Titanium Supracondylar Nail · Depuy, Inc. · 1998K023115 · Ace Versanail · DePuy Orthopaedics, Inc. · 2002K101934 · Dynnail, 12MM, Locking Screw, 4.6 MM, Deployment Frame, Dynnail, Models 1200-01-1222, 1200-02-46XX, 2200-01-0000 · Medshape Solutions · 2011K113828 · Dynanail Ankle Arthrodesis Nail · MedShape, Inc. · 2012K171376 · DynaNail TTC Fusion System · MedShape, Inc. · 2017199520002005201020152020
Other ancestors, by generation 1 generation back: 2 other ancestors3 generations back: 4 other ancestors K171376 · DynaNail TTC Fusion System · MedShape, Inc. · 2017K113828 · Dynanail Ankle Arthrodesis Nail · MedShape, Inc. · 2012K101934 · Dynnail, 12MM, Locking Screw, 4.6 MM, Deployment Frame, Dynnail, Models 1200-01-1222, 1200-02-46XX, 2200-01-0000 · Medshape Solutions · 2011K023115 · Ace Versanail · DePuy Orthopaedics, Inc. · 2002K974781 · Depuy Ace Aim (R) Titanium Supracondylar Nail · Depuy, Inc. · 1998−50
  1. Root · 5 generations backK974781 Depuy Ace Aim (R) Titanium Supracondylar NailDepuy, Inc. · 1998
  2. 4 generations backK023115 Ace VersanailDePuy Orthopaedics, Inc. · 2002
  3. 3 generations backK101934 Dynnail, 12MM, Locking Screw, 4.6 MM, Deployment Frame, Dynnail…Medshape Solutions · 2011
  4. 2 generations backK113828 Dynanail Ankle Arthrodesis NailMedShape, Inc. · 2012
  5. 1 generation backK171376 DynaNail TTC Fusion SystemMedShape, Inc. · 2017
  6. This deviceK221031 Arthrex DualCompression Hindfoot Fusion Nail Implant SystemArthrex, Inc. · 2022
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K974781Depuy Ace Aim (R) Titanium Supracondylar NailDepuy, Inc.1998—
−4K023115Ace VersanailDePuy Orthopaedics, Inc.2002—
−3K101934Dynnail, 12MM, Locking Screw, 4.6 MM, Deployment Frame, Dynnail, Models…Medshape Solutions2011—
−2K113828Dynanail Ankle Arthrodesis NailMedShape, Inc.2012—
−1K171376DynaNail TTC Fusion SystemMedShape, Inc.2017—
0 (this device)K221031Arthrex DualCompression Hindfoot Fusion Nail Implant SystemArthrex, Inc.2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199820
199910
200010
200910
201410
FIG. 1 — Lineage of K221031, 1998–2022Source: 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? (4)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K090857Valor Ankle Fusion Nail System
Summary page 4
…cessories Product Code HSB Classification Name 21 CFR 888.3020: Intramedullary fixation rod Regulatory Class II Predicate Device K090857: Wright Medical VALOR Ankle Fusion Nail System Reference Device K142602: Wright Medical VALOR Hindfoot Fusion Nail Syst…
Wrightmedicaltechnologyinc20095
*K142602VALOR Hindfoot Fusion Nail System
Summary page 4
…0: Intramedullary fixation rod Regulatory Class II Predicate Device K090857: Wright Medical VALOR Ankle Fusion Nail System Reference Device K142602: Wright Medical VALOR Hindfoot Fusion Nail System K171376: Medshape Solutions DynaNail TTC Fusion Syst…
Wrightmedicaltechnologyinc2014—
*K171376DynaNail TTC Fusion System
Summary page 4
…K090857: Wright Medical VALOR Ankle Fusion Nail System Reference Device K142602: Wright Medical VALOR Hindfoot Fusion Nail System K171376: Medshape Solutions DynaNail TTC Fusion System K113828: Medshape Solutions DynaNail Ankle Arthrodesis…
MedShape, Inc.2017—
*K113828Dynanail Ankle Arthrodesis Nail
Summary page 4
…K142602: Wright Medical VALOR Hindfoot Fusion Nail System K171376: Medshape Solutions DynaNail TTC Fusion System K113828: Medshape Solutions DynaNail Ankle Arthrodesis Nail Purpose of This Traditional 510(k) premarket notification is…
MedShape, Inc.2012—

Also cleared against K090857: 6 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 24 years and passes through 5 companies; a new generation was cleared every 5.1 years on median.
  • 2 of the 11 ancestors have a recall of any class.
  • 6 other devices also cite its predicate K090857.

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. 2022, 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 Arthrex DualCompression Hindfoot Fusion Nail Implant 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K090857

6 other devices cite the same predicate.

  • K230088Ankle Truss System (ATS)4Web Medical, Inc. · 2024
  • K142602VALOR Hindfoot Fusion Nail SystemWrightmedicaltechnologyinc · 2014
  • K123810Piccolo Composite Ankle Arthrodesis Nailing SystemCarboFix Orthopedics, Ltd. · 2013
  • K121575Oxford Ankle Fusion Nail (Afn) SystemOrtho Solutions Limited · 20121 recall
  • K102413Fuze: Intramedullary Internal Fixation NailVilex, Inc. · 20113 recalls
  • K110552Valor (R) Ankle Fusion Nail System ScrewWrightmedicaltechnologyinc · 2011

More from Arthrex, Inc.

355 FDA decisions under this applicant name. See the company

  • K262975Arthrex Beaming SystemArthrex, Inc. · 2026
  • K262618Arthrex Spine Compression FT ScrewArthrex, Inc. · 2026
  • K262451Arthrex DynaNite StaplesArthrex, Inc. · 2026
  • K262357Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc. · 2026
  • K260624Arthrex Radial Head Replacement SystemArthrex, Inc. · 2026

Recent decisions in HSB

The HSB category page

  • K261189Freedom Nail Ankle Fusion SystemMcGinley Orthopaedic Innovations · 2026
  • K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp. · 2026
  • K261481Pangea Femur Reconstruction SystemStryker GmbH · 2026
  • K253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)Suzhou and Science & Technology Development Corp. · 2026
  • K261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized Orthopedics · 2026

https://510kreport.com/device/K221031 · printed Nov 6, 2026

Cite this page

510(k) Report. “K221031: Arthrex DualCompression Hindfoot Fusion Nail Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221031

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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