510(k) · Cleared
ClearedAgility LP Total Ankle Prosthesis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DePuy Orthopaedics, Inc. · HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Cleared on Mar 31, 2006 as substantially equivalent to K920802 (Depuy, Inc., 1992) after a 99-day review. Its family tree reaches back 1 generation to 1992. 53 later devices descend from it.
- Decided
- Mar 31, 2006
- Review
- 99 days
- Class
- Class II
- Product code
- HSN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K920802 (1992). 53 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK920802 Alvine Total AnkleDepuy, Inc. · 1992
- This deviceK053569 Agility LP Total Ankle ProsthesisDePuy Orthopaedics, Inc. · 2006
- Descendant · cites it directly · 52 of its ownK123954 Infinity Total Ankle SystemWrightmedicaltechnologyinc · 2013 · Recalled
- Descendant · 2 generations on · 48 of its ownK140749 Infinity Total Ankle SystemWrightmedicaltechnologyinc · 2014 · Recalled
- Descendant · 2 generations on · 34 of its ownK133585 Inbone Total AnkleWrightmedicaltechnologyinc · 2014
- Descendant · 2 generations on · 29 of its ownK153008 INVISION Total Ankle Revision SystemWrightmedicaltechnologyinc · 2016
- Descendant · 2 generations on · 29 of its ownK142117 Invision Total Ankle Revision SystemWrightmedicaltechnologyinc · 2015
Showing 5 of 53 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 53 · See all- K123954Infinity Total Ankle SystemWrightmedicaltechnologyinc · 2013 · cites it directly52descendants
- K140749Infinity Total Ankle SystemWrightmedicaltechnologyinc · 2014 · 2 generations on48descendants
- K133585Inbone Total AnkleWrightmedicaltechnologyinc · 2014 · 2 generations on34descendants
- K153008INVISION Total Ankle Revision SystemWrightmedicaltechnologyinc · 2016 · 2 generations on29descendants
- K142117Invision Total Ankle Revision SystemWrightmedicaltechnologyinc · 2015 · 2 generations on29descendants
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) | K053569 | Agility LP Total Ankle Prosthesis | DePuy Orthopaedics, Inc. | 2006 | — |
| +1 | K123954 | Infinity Total Ankle System | Wrightmedicaltechnologyinc | 2013 | 2 |
| +2 | K140749 | Infinity Total Ankle System | Wrightmedicaltechnologyinc | 2014 | 1 |
| +2 | K133585 | Inbone Total Ankle | Wrightmedicaltechnologyinc | 2014 | — |
| +2 | K153008 | INVISION Total Ankle Revision System | Wrightmedicaltechnologyinc | 2016 | — |
| +2 | K142117 | Invision Total Ankle Revision System | Wrightmedicaltechnologyinc | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 4 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 6 | 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 1…l Ankle Prosthesis proposed in this submission are a line extension to the AgilityT M Total Ankle system components (cleared as DePuy Alvine Total Ankle Prosthesis under K920802, December 17, 1992). The Agility LP Ankle is a modular ankle prosthesis that is comprised of a tibial tray, a polyethylene tibial… | 1992 |
What descends from it? (53)
See all 531 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123954 | Infinity Total Ankle System | 2013 | 52 |
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 in elderly individuals with reduced activity levels.
CAUTION: The Agility Ankle Prosthesis is intended for cemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053569 · printed Nov 4, 2026
Cite this page
510(k) Report. “K053569: Agility LP Total Ankle Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K053569
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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