510(k) Report

510(k) · Cleared

Recalled · Class II · 2017

Oxford Ankle Fusion Nail (Afn) System

K121575510(k) TraditionalCleared Sep 14, 2012107-day reviewClass II21 CFR 888.3020Recalls 1

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

Ortho Solutions Limited · HSB Rod, Fixation, Intramedullary And Accessories

Cleared on Sep 14, 2012 as substantially equivalent to K023115 (DePuy Orthopaedics, Inc., 2002) and 10 other predicates after a 107-day review. Its family tree reaches back 4 generations to 1998. 1 later device descends from it. It has been recalled once.

Decided
Sep 14, 2012
Review
107 days
Class
Class II
Product code
HSB
Recalls
1
Predicates
11

Its longest line of descent runs back 4 generations to K982953 (1998). 19 ancestors in all, the oldest K950394 (1995). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2011: 1 other ancestor2009: 2 other ancestors2008: 1 other ancestor2005: 1 other ancestor2004: 1 other ancestor2002: 2 other ancestors2000: 1 other ancestor2007: 2 other ancestors1999: 1 other ancestor1998: 2 other ancestors1995: 1 other ancestor2025: 1 descendant clearedK982953 · Titanium Intramedullary Nails-Various Styles · Biomet, Inc. · 1998 · recalledK021786 · Titanium Ankle Arthrodesis Nail · Biomet, Inc. · 2002 · recalledK050882 · Newdeal Ankle Nail · New Deal, S.A. · 2005 · recalledK091788 · Panta Nail (Dia. 10MM), Panta Nail XL · Newdeal Sas · 2009 · recalled1995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 9 other ancestors2 generations back: 6 other ancestors 1 generation forward: 1 descendant K091788 · Panta Nail (Dia. 10MM), Panta Nail XL · Newdeal Sas · 2009 · recalledK050882 · Newdeal Ankle Nail · New Deal, S.A. · 2005 · recalledK021786 · Titanium Ankle Arthrodesis Nail · Biomet, Inc. · 2002 · recalledK982953 · Titanium Intramedullary Nails-Various Styles · Biomet, Inc. · 1998 · recalled0
  1. Root · 4 generations backK982953 Titanium Intramedullary Nails-Various StylesBiomet, Inc. · 1998 · Recalled
  2. 3 generations backK021786 Titanium Ankle Arthrodesis NailBiomet, Inc. · 2002 · Recalled
  3. 2 generations backK050882 Newdeal Ankle NailNew Deal, S.A. · 2005 · Recalled
  4. 1 generation backK091788 Panta Nail (Dia. 10MM), Panta Nail XLNewdeal Sas · 2009 · Recalled
  5. This deviceK121575 Oxford Ankle Fusion Nail (Afn) SystemOrtho Solutions Limited · 2012
  6. Descendant · cites it directly · 0 of its ownK250622 Succession™ AFN SystemOrtho Solutions UK, Ltd. · 2025

Most influential descendants

Showing 1 of 1 · See all
  • K250622Succession™ AFN SystemOrtho Solutions UK, Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K982953Titanium Intramedullary Nails-Various StylesBiomet, Inc.19984
−3K021786Titanium Ankle Arthrodesis NailBiomet, Inc.20021
−2K050882Newdeal Ankle NailNew Deal, S.A.20055
−1K091788Panta Nail (Dia. 10MM), Panta Nail XLNewdeal Sas20092
0 (this device)K121575Oxford Ankle Fusion Nail (Afn) SystemOrtho Solutions Limited2012—
+1K250622Succession™ AFN SystemOrtho Solutions UK, Ltd.2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
199820
199910
200010
200220
200410
200510
200720
200810
200920
201110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202510
FIG. 1 — Lineage of K121575, 1998–2025Source: 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? (11)

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
*K023115Ace Versanail
Summary page 1
…sories (See 2JCFR. Sec. 888.3030). DEVICE PRODUCT CODE: HSB SUBSTANTIALLY EQUIVALENT DEVICES DePuyACE - VersaNailTM 'ITC Fusion Nail (K0231 15 & K003797) Smith & Nephew - TRIGENTM Hindfoot Fusion Nail (K043052) Str…
DePuy Orthopaedics, Inc.2002—
*K003797Ace Aim TTC Fusion Nail
Summary page 1
…2JCFR. Sec. 888.3030). DEVICE PRODUCT CODE: HSB SUBSTANTIALLY EQUIVALENT DEVICES DePuyACE - VersaNailTM 'ITC Fusion Nail (K0231 15 & K003797) Smith & Nephew - TRIGENTM Hindfoot Fusion Nail (K043052) Stryker - T2®…
DePuy Orthopaedics, Inc.2000—
*K043052Trigen Hindfoot Fusion Nail
Summary page 1
…LY EQUIVALENT DEVICES DePuyACE - VersaNailTM 'ITC Fusion Nail (K0231 15 & K003797) Smith & Nephew - TRIGENTM Hindfoot Fusion Nail (K043052) Stryker - T2®T m Ankle Arthrodesis Nail1 (K051590, K020384) Biomet - P…
Smith & Nephew, Inc.20047
*K051590T2 Ankle Arthrodesis Nail
Summary page 1
…5 & K003797) Smith & Nephew - TRIGENTM Hindfoot Fusion Nail (K043052) Stryker - T2®T m Ankle Arthrodesis Nail1 (K051590, K020384) Biomet - PhoenixTM Nail System (K091976, K081243) Wright Medi…
Howmedica Osteonics Corp.20058
*K020384T2 Arthrodesis Nail System
Summary page 1
…97) Smith & Nephew - TRIGENTM Hindfoot Fusion Nail (K043052) Stryker - T2®T m Ankle Arthrodesis Nail1 (K051590, K020384) Biomet - PhoenixTM Nail System (K091976, K081243) Wright Medical - VAL…
Howmedica Osteonics Corp.20021
*K091976Biomet Phoenix Ankle Nail and Ankle Arthrodesis Nail
Summary page 1
…sion Nail (K043052) Stryker - T2®T m Ankle Arthrodesis Nail1 (K051590, K020384) Biomet - PhoenixTM Nail System (K091976, K081243) Wright Medical - VALOR®TM Ankle Fusion Nail (K1 10552 & K0908…
Biomet Trauma20092
*K081243Biomet Phoenix Ankle Nail System
Summary page 1
…(K043052) Stryker - T2®T m Ankle Arthrodesis Nail1 (K051590, K020384) Biomet - PhoenixTM Nail System (K091976, K081243) Wright Medical - VALOR®TM Ankle Fusion Nail (K1 10552 & K090857)…
Biomet Trauma2008—
*K110552Valor (R) Ankle Fusion Nail System Screw
Summary page 1
…051590, K020384) Biomet - PhoenixTM Nail System (K091976, K081243) Wright Medical - VALOR®TM Ankle Fusion Nail (K1 10552 & K090857) Integra - PANTA® Arthrodesis Nail (K091788, K050882) DEVICE…
Wrightmedicaltechnologyinc2011—
*K090857Valor Ankle Fusion Nail System
Summary page 1
…Biomet - PhoenixTM Nail System (K091976, K081243) Wright Medical - VALOR®TM Ankle Fusion Nail (K1 10552 & K090857) Integra - PANTA® Arthrodesis Nail (K091788, K050882) DEVICE DESCRIPTION: The Ortho Soluti…
Wrightmedicaltechnologyinc20095
*K091788Panta Nail (Dia. 10MM), Panta Nail XL
Summary page 1
…Wright Medical - VALOR®TM Ankle Fusion Nail (K1 10552 & K090857) Integra - PANTA® Arthrodesis Nail (K091788, K050882) DEVICE DESCRIPTION: The Ortho Solutions Oxford Ankle Fusion Nail (AFN) System is…
Newdeal Sas20092
*K050882Newdeal Ankle Nail
Summary page 1
…Wright Medical - VALOR®TM Ankle Fusion Nail (K1 10552 & K090857) Integra - PANTA® Arthrodesis Nail (K091788, K050882) DEVICE DESCRIPTION: The Ortho Solutions Oxford Ankle Fusion Nail (AFN) System is composed…
New Deal, S.A.20055

Also cleared against K023115: 6 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K250622Succession™ AFN SystemOrtho Solutions UK, Ltd.20250

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

Recalls of this device

DateClassRecallRoot causeReason
Apr 19, 2017Class IIZ-2780-2017Error in labelingThere is a material mislabeling of the AFN End Cap.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 14 years and passes through 4 companies; a new generation was cleared every 3.8 years on median.
  • 10 of the 19 ancestors have a recall of any class.
  • Of its descendants, K250622 (Ortho Solutions UK, Ltd., 2025) has gone furthest, with 0 descendants of its own.
  • 6 other devices also cite its predicate K023115.

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. 2012, 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 Ortho Solutions Limited Oxford Ankle Fusion Nail (AFN) System is a tibiotalocalcaneal (TIC) solid fusion system that has been developed for the following indications:

> Failed ankle replacement

> Arthritis of ankle and subtalar joint

> Correcting neuromuscular imbalance of hindfoot, where bone fusion is required

> Revision of failed ankle and/or subtalar fusion

> Revision of failed Tibiota local canealI (TTC) fusion

> Talar Avascular Necrosis (AFN)

> Charcot

> Trauma

> Neuroarthropathy

> Pseudoarthrosis

> Rheumatoid arthritis

Indications for use as stated in the FDA summary.

Also cleared against K023115

6 other devices cite the same predicate.

  • K111663Trauma Internal Fixation SystemsDePuy Orthopaedics, Inc. · 201217 recalls
  • K113828Dynanail Ankle Arthrodesis NailMedShape, Inc. · 2012
  • K101934Dynnail, 12MM, Locking Screw, 4.6 MM, Deployment Frame, Dynnail, Models 1200-01-1222, 1200-02-46XX…Medshape Solutions · 2011
  • K091788Panta Nail (Dia. 10MM), Panta Nail XLNewdeal Sas · 20092 recalls
  • K070761Sanatmetal Nails and PinsSanatmetal Mfr. of Orthopaedic/Traumatologic Prod. · 2008
  • K050882Newdeal Ankle NailNew Deal, S.A. · 20055 recalls

More from Ortho Solutions Limited

6 FDA decisions under this applicant name. See the company

  • K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited · 20142 recalls
  • K120360Ortho Solutions Trauma Plates for OsteosysnthesisOrtho Solutions Limited · 2012
  • K111678Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited · 20121 recall
  • K110895Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited · 2011
  • K102743Ortho Solutions - Sterile, Drills, Taps, Guide Pins & WiresOrtho Solutions Limited · 2011

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/K121575 · printed Nov 6, 2026

Cite this page

510(k) Report. “K121575: Oxford Ankle Fusion Nail (Afn) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121575

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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