510(k) · Cleared
ClearedAPEX 3D Total Ankle Replacement System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Paragon 28, Inc. · HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Cleared on Jun 24, 2024 as substantially equivalent to K192994 (Paragon 28, Inc., 2020) after a 145-day review. Its family tree reaches back 9 generations to 1992.
- Decided
- Jun 24, 2024
- Review
- 145 days
- Class
- Class II
- Product code
- HSN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K920802 (1992). 31 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK920802 Alvine Total AnkleDepuy, Inc. · 1992
- 5 generations between
- 3 generations backK141740 Infinity (TM) Total Ankle System; Inbone Total Ankle SystemWrightmedicaltechnologyinc · 2015
- 2 generations backK171067 INVISION Total Ankle Revision SystemWrightmedicaltechnologyinc · 2017
- 1 generation backK192994 Paragon 28 APEX 3D Total Ankle Replacement SystemParagon 28, Inc. · 2020
- This deviceK240259 APEX 3D Total Ankle Replacement SystemParagon 28, Inc. · 2024
Show all 9 generations
- Root · 9 generations backK920802 Alvine Total AnkleDepuy, Inc. · 1992
- 8 generations backK020541 Agility Ankle Revision ProsthesisDepuy, Inc. · 2002
- 7 generations backK051023 Topez Total Ankle ReplacementTopez Orthopedics, Inc. · 2005 · Recalled
- 6 generations backK100886 Inbone II Total Ankle ReplacementWrightmedicaltechnologyinc · 2010 · Recalled
- 5 generations backK123954 Infinity Total Ankle SystemWrightmedicaltechnologyinc · 2013 · Recalled
- 4 generations backK140749 Infinity Total Ankle SystemWrightmedicaltechnologyinc · 2014 · Recalled
- 3 generations backK141740 Infinity (TM) Total Ankle System; Inbone Total Ankle SystemWrightmedicaltechnologyinc · 2015
- 2 generations backK171067 INVISION Total Ankle Revision SystemWrightmedicaltechnologyinc · 2017
- 1 generation backK192994 Paragon 28 APEX 3D Total Ankle Replacement SystemParagon 28, Inc. · 2020
- This deviceK240259 APEX 3D Total Ankle Replacement SystemParagon 28, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K920802 | Alvine Total Ankle | Depuy, Inc. | 1992 | — |
| −8 | K020541 | Agility Ankle Revision Prosthesis | Depuy, Inc. | 2002 | — |
| −7 | K051023 | Topez Total Ankle Replacement | Topez Orthopedics, Inc. | 2005 | 4 |
| −6 | K100886 | Inbone II Total Ankle Replacement | Wrightmedicaltechnologyinc | 2010 | 2 |
| −5 | K123954 | Infinity Total Ankle System | Wrightmedicaltechnologyinc | 2013 | 2 |
| −4 | K140749 | Infinity Total Ankle System | Wrightmedicaltechnologyinc | 2014 | 1 |
| −3 | K141740 | Infinity (TM) Total Ankle System; Inbone Total Ankle System | Wrightmedicaltechnologyinc | 2015 | — |
| −2 | K171067 | INVISION Total Ankle Revision System | Wrightmedicaltechnologyinc | 2017 | — |
| −1 | K192994 | Paragon 28 APEX 3D Total Ankle Replacement System | Paragon 28, Inc. | 2020 | — |
| 0 (this device) | K240259 | APEX 3D Total Ankle Replacement System | Paragon 28, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 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 16.7 · 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 |
|---|---|---|---|
| * | K192994 | Paragon 28 APEX 3D Total Ankle Replacement SystemSummary page 5…K240259 Page 2 of 2 Primary Predicate: Paragon 28 APEX 3D Total Ankle Replacement System (K192994) Reference Device: INBONE Total Ankle System (K193067) Substantial The APEX 3D Total Ankle Replacement System i… | 2020 |
| † | K193067 | The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total… | 2020 |
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 32 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
- 15 of the 31 ancestors have a recall of any class.
- 4 other devices also cite its predicate K192994.
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. 2024, this device’s year, is highlighted.
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?
The APEX 3D Total Ankle Replacement System is indicated as a total ankle replacement in primary surgery for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. Revision surgery for these patients is also indicated for patients with sufficient bone stock present. In the United States, components are intended for cemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240259 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240259: APEX 3D Total Ankle Replacement System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240259
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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