510(k) · Cleared
ClearedSuccession™ AFN System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho Solutions UK, Ltd. · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Aug 7, 2025 as substantially equivalent to K121575 (Ortho Solutions Limited, 2012) and 1 other predicate after a 160-day review. Its family tree reaches back 5 generations to 1998.
- Decided
- Aug 7, 2025
- Review
- 160 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K982953 (1998). 21 ancestors in all, the oldest K950394 (1995). No later device cites it as a predicate yet.
- Root · 5 generations backK982953 Titanium Intramedullary Nails-Various StylesBiomet, Inc. · 1998 · Recalled
- 4 generations backK021786 Titanium Ankle Arthrodesis NailBiomet, Inc. · 2002 · Recalled
- 3 generations backK050882 Newdeal Ankle NailNew Deal, S.A. · 2005 · Recalled
- 2 generations backK091788 Panta Nail (Dia. 10MM), Panta Nail XLNewdeal Sas · 2009 · Recalled
- 1 generation backK121575 Oxford Ankle Fusion Nail (Afn) SystemOrtho Solutions Limited · 2012 · Recalled
- This deviceK250622 Succession™ AFN SystemOrtho Solutions UK, Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K982953 | Titanium Intramedullary Nails-Various Styles | Biomet, Inc. | 1998 | 4 |
| −4 | K021786 | Titanium Ankle Arthrodesis Nail | Biomet, Inc. | 2002 | 1 |
| −3 | K050882 | Newdeal Ankle Nail | New Deal, S.A. | 2005 | 5 |
| −2 | K091788 | Panta Nail (Dia. 10MM), Panta Nail XL | Newdeal Sas | 2009 | 2 |
| −1 | K121575 | Oxford Ankle Fusion Nail (Afn) System | Ortho Solutions Limited | 2012 | 1 |
| 0 (this device) | K250622 | Succession™ AFN System | Ortho Solutions UK, Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
| 2018 | 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? (2)
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 |
|---|---|---|---|
| * | K121575 | Oxford Ankle Fusion Nail (Afn) SystemSummary page 5…ary Fixation Rod Regulation Number: 888.3020 Product Code: HSB Legally Marketed Predicate Devices: Predicate Number: K121575 (Primary Predicate) Predicate Trade Name: Oxford™ Ankle Fusion Nail (AFN) System Predicate Number: K17… | 2012 |
| * | K173811 | TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis SystemSummary page 5…: Predicate Number: K121575 (Primary Predicate) Predicate Trade Name: Oxford™ Ankle Fusion Nail (AFN) System Predicate Number: K173811 (Secondary Predicate) Predicate Trade Name: In2Bones TriWay® Tibiotalocalcaneal (TTC) Arthrodesis System Device De… | 2018 |
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 27 years and passes through 5 companies; a new generation was cleared every 3.8 years on median.
- 11 of the 21 ancestors have a recall of any class.
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. 2025, 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 Succession TM Ankle Fusion Nail (AFN) System is a tibiotalocalcaneal (TTC) 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 Tibiotalocalcaneal (TTC) fusion
- Talar Avascular Necrosis (AVN)
- Charcot
- Trauma
- Neuroarthropathy
- Pseudoarthrosis
- Rheumatoid arthritis
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250622 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250622: Succession™ 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/K250622
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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