510(k) · Cleared
ClearedParagon 28 APEX 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 Jul 10, 2020 as substantially equivalent to K171067 (Wrightmedicaltechnologyinc, 2017) and 2 other predicates after a 259-day review. Its family tree reaches back 8 generations to 1992. 8 later devices descend from it.
- Decided
- Jul 10, 2020
- Review
- 259 days
- Class
- Class II
- Product code
- HSN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K920802 (1992). 30 ancestors in all. 8 later devices descend from it, 5 citing it directly.
- Root · 8 generations backK920802 Alvine Total AnkleDepuy, Inc. · 1992
- 7 generations backK020541 Agility Ankle Revision ProsthesisDepuy, Inc. · 2002
- 6 generations backK051023 Topez Total Ankle ReplacementTopez Orthopedics, Inc. · 2005 · Recalled
- 5 generations backK100886 Inbone II Total Ankle ReplacementWrightmedicaltechnologyinc · 2010 · Recalled
- 4 generations backK123954 Infinity Total Ankle SystemWrightmedicaltechnologyinc · 2013 · Recalled
- 3 generations backK140749 Infinity Total Ankle SystemWrightmedicaltechnologyinc · 2014 · Recalled
- 2 generations backK141740 Infinity (TM) Total Ankle System; Inbone Total Ankle SystemWrightmedicaltechnologyinc · 2015
- 1 generation backK171067 INVISION Total Ankle Revision SystemWrightmedicaltechnologyinc · 2017
- This deviceK192994 Paragon 28 APEX 3D Total Ankle Replacement SystemParagon 28, Inc. · 2020
- Descendant · cites it directly · 2 of its ownK210390 Apex 3D Total Ankle Replacement SystemParagon 28, Inc. · 2021
- Descendant · 2 generations on · 1 of its ownK231231 MR Safety and Compatibility Testing and Labeling for Paragon 28…Paragon 28, Inc. · 2023
- Descendant · cites it directly · 1 of its ownK202019 Maven Patient-Specific InstrumentationParagon 28, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK250641 APEX 3D Total Ankle Replacement SystemParagon 28, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK240259 APEX 3D Total Ankle Replacement SystemParagon 28, Inc. · 2024
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K210390Apex 3D Total Ankle Replacement SystemParagon 28, Inc. · 2021 · cites it directly2descendants
- K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc. · 2023 · 2 generations on1descendant
- K202019Maven Patient-Specific InstrumentationParagon 28, Inc. · 2021 · cites it directly1descendant
- K250641APEX 3D Total Ankle Replacement SystemParagon 28, Inc. · 2025 · cites it directly0descendants
- K240259APEX 3D Total Ankle Replacement SystemParagon 28, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K920802 | Alvine Total Ankle | Depuy, Inc. | 1992 | — |
| −7 | K020541 | Agility Ankle Revision Prosthesis | Depuy, Inc. | 2002 | — |
| −6 | K051023 | Topez Total Ankle Replacement | Topez Orthopedics, Inc. | 2005 | 4 |
| −5 | K100886 | Inbone II Total Ankle Replacement | Wrightmedicaltechnologyinc | 2010 | 2 |
| −4 | K123954 | Infinity Total Ankle System | Wrightmedicaltechnologyinc | 2013 | 2 |
| −3 | K140749 | Infinity Total Ankle System | Wrightmedicaltechnologyinc | 2014 | 1 |
| −2 | K141740 | Infinity (TM) Total Ankle System; Inbone Total Ankle System | Wrightmedicaltechnologyinc | 2015 | — |
| −1 | K171067 | INVISION Total Ankle Revision System | Wrightmedicaltechnologyinc | 2017 | — |
| 0 (this device) | K192994 | Paragon 28 APEX 3D Total Ankle Replacement System | Paragon 28, Inc. | 2020 | — |
| +1 | K210390 | Apex 3D Total Ankle Replacement System | Paragon 28, Inc. | 2021 | — |
| +2 | K231231 | MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic… | Paragon 28, Inc. | 2023 | — |
| +1 | K202019 | Maven Patient-Specific Instrumentation | Paragon 28, Inc. | 2021 | — |
| +1 | K250641 | APEX 3D Total Ankle Replacement System | Paragon 28, Inc. | 2025 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 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 K250037 Incompass Total Ankle Systemscore 15.2 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K171067 | INVISION Total Ankle Revision SystemSummary page 5…Summary: Performance data for the Paragon 28 APEX 3D Total Ankle Replacement System demonstrate its substantial equivalence to the INVISION Total Ankle Revision System (K171067), Salto XT, Salto Talaris (K153452) and the Integra Cadence Total Ankle System (K151459). Testing performed on the subject device… | 2017 |
| * | K153452 | Salto XT, Salto TalarisSummary page 5…Paragon 28 APEX 3D Total Ankle Replacement System demonstrate its substantial equivalence to the INVISION Total Ankle Revision System (K171067), Salto XT, Salto Talaris (K153452) and the Integra Cadence Total Ankle System (K151459). Testing performed on the subject devices includes: • Range of Motion… | 2016 |
| * | K151459 | Integra Total Ankle Replacement SystemSummary page 5…onstrate its substantial equivalence to the INVISION Total Ankle Revision System (K171067), Salto XT, Salto Talaris (K153452) and the Integra Cadence Total Ankle System (K151459). Testing performed on the subject devices includes: • Range of Motion • Contact Stress and Contact Area • Constraint… | 2015 |
What descends from it? (8)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 28 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
- 15 of the 30 ancestors have a recall of any class.
- Of its descendants, K210390 (Paragon 28, Inc., 2021) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K171067.
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. 2020, 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. Components are 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/K192994 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192994: Paragon 28 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/K192994
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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