510(k) · Cleared
ClearedAgility Ankle Revision Prosthesis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy, Inc. · HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Cleared on May 20, 2002 as substantially equivalent to K920802 (Depuy, Inc., 1992) after a 90-day review. Its family tree reaches back 1 generation to 1992. 66 later devices descend from it.
- Decided
- May 20, 2002
- Review
- 90 days
- Class
- Class II
- Product code
- HSN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K920802 (1992). 66 later devices descend from it, 6 citing it directly.
- Root · 1 generation backK920802 Alvine Total AnkleDepuy, Inc. · 1992
- This deviceK020541 Agility Ankle Revision ProsthesisDepuy, Inc. · 2002
- Descendant · cites it directly · 64 of its ownK051023 Topez Total Ankle ReplacementTopez Orthopedics, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 56 of its ownK100886 Inbone II Total Ankle ReplacementWrightmedicaltechnologyinc · 2010 · Recalled
- Descendant · 2 generations on · 52 of its ownK123954 Infinity Total Ankle SystemWrightmedicaltechnologyinc · 2013 · Recalled
- Descendant · 3 generations on · 48 of its ownK140749 Infinity Total Ankle SystemWrightmedicaltechnologyinc · 2014 · Recalled
- Descendant · 3 generations on · 34 of its ownK133585 Inbone Total AnkleWrightmedicaltechnologyinc · 2014
Showing 5 of 66 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 66 · See all- K051023Topez Total Ankle ReplacementTopez Orthopedics, Inc. · 2005 · cites it directly64descendants
- K100886Inbone II Total Ankle ReplacementWrightmedicaltechnologyinc · 2010 · 2 generations on56descendants
- K123954Infinity Total Ankle SystemWrightmedicaltechnologyinc · 2013 · 2 generations on52descendants
- K140749Infinity Total Ankle SystemWrightmedicaltechnologyinc · 2014 · 3 generations on48descendants
- K133585Inbone Total AnkleWrightmedicaltechnologyinc · 2014 · 3 generations on34descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K920802 | Alvine Total Ankle | Depuy, Inc. | 1992 | — |
| 0 (this device) | K020541 | Agility Ankle Revision Prosthesis | Depuy, Inc. | 2002 | — |
| +1 | K051023 | Topez Total Ankle Replacement | Topez Orthopedics, Inc. | 2005 | 4 |
| +2 | K100886 | Inbone II Total Ankle Replacement | Wrightmedicaltechnologyinc | 2010 | 2 |
| +2 | K123954 | Infinity Total Ankle System | Wrightmedicaltechnologyinc | 2013 | 2 |
| +3 | K140749 | Infinity Total Ankle System | Wrightmedicaltechnologyinc | 2014 | 1 |
| +3 | K133585 | Inbone Total Ankle | Wrightmedicaltechnologyinc | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 4 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 4 | 0 |
| 2018 | 4 | 0 |
| 2019 | 2 | 0 |
| 2020 | 7 | 0 |
| 2021 | 4 | 0 |
| 2022 | 1 | 0 |
| 2023 | 9 | 0 |
| 2024 | 12 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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 HSN? 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 HSN device
- #1 K192994 Paragon 28 APEX 3D Total Ankle Replacement…score 16.8 · 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 |
|---|---|---|---|
| * | K920802 | Alvine Total AnkleSummary page 2…gility Ankle Revision Prosthesis is demonstrated by its similarity in indications for use, design, materials, sterilization and packaging to the Agility Ankle cleared in K920802 (formerly called the Alvine Ankle). The determination of substantial equivalence for this device was based on a detailed device… | 1992 |
What descends from it? (66)
See all 666 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051023 | Topez Total Ankle Replacement | 2005 | 64 |
| K060544 | Salto Talaris Total Ankle Prosthesis | 2006 | 23 |
| K090076 | Salto Talaris Total Ankle Prosthesis | 2009 | 21 |
| K130533 | Salto Talaris Total Ankle Prosthesis, RHS | 2013 | 16 |
| K120906 | Zimmer Trabecular Metal Total Ankle | 2012 | 1 |
| K061749 | Eclipse Total Ankle Implant | 2006 | 0 |
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 HSN devicesHSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HSN
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HSN
58in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HSN
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HSN
1,645in 2025
MAUDE reports naming product code HSN, 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 | 0 | — | 0 | 50 |
| 2008 | 0 | — | 0 | 66 |
| 2009 | 1 | — | 0 | 66 |
| 2010 | 2 | — | 0 | 120 |
| 2011 | 1 | — | 0 | 139 |
| 2012 | 2 | — | 0 | 100 |
| 2013 | 4 | 89 | 3 | 106 |
| 2014 | 2 | — | 0 | 65 |
| 2015 | 3 | 233 | 0 | 73 |
| 2016 | 3 | 216 | 1 | 111 |
| 2017 | 4 | 148 | 2 | 96 |
| 2018 | 4 | 89 | 0 | 187 |
| 2019 | 2 | — | 1 | 277 |
| 2020 | 6 | 234 | 0 | 281 |
| 2021 | 4 | 109 | 3 | 237 |
| 2022 | 1 | — | 2 | 453 |
| 2023 | 6 | 112 | 1 | 796 |
| 2024 | 7 | 115 | 0 | 1,095 |
| 2025 | 3 | 58 | 0 | 1,645 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Total ankle arthroplasty is intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint. Total ankle arthroplasty is indicated for patients with ankle joints damaged by severe rheumatoid, post traumatic or degenerative arthritis.
The Agility Ankle Revision Prosthesis is additionally indicated for patients with a failed previous ankle surgery.
CAUTION: The Agility Ankle Prosthesis is intended for cemented use only.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020541 · printed Nov 4, 2026
Cite this page
510(k) Report. “K020541: Agility Ankle Revision Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K020541
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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