510(k) · Cleared
Recalled · Class II · 2017Integra Total Ankle Replacement System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ascension Orthopedics · HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Cleared on Aug 31, 2015 as substantially equivalent to K100886 (Wrightmedicaltechnologyinc, 2010) after a 91-day review. Its family tree reaches back 4 generations to 1992. 14 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 31, 2015
- Review
- 91 days
- Class
- Class II
- Product code
- HSN
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 4 generations to K920802 (1992). 14 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK920802 Alvine Total AnkleDepuy, Inc. · 1992
- 3 generations backK020541 Agility Ankle Revision ProsthesisDepuy, Inc. · 2002
- 2 generations backK051023 Topez Total Ankle ReplacementTopez Orthopedics, Inc. · 2005 · Recalled
- 1 generation backK100886 Inbone II Total Ankle ReplacementWrightmedicaltechnologyinc · 2010 · Recalled
- This deviceK151459 Integra Total Ankle Replacement SystemAscension Orthopedics · 2015
- Descendant · cites it directly · 8 of its ownK192994 Paragon 28 APEX 3D Total Ankle Replacement SystemParagon 28, Inc. · 2020
- Descendant · 2 generations on · 2 of its ownK210390 Apex 3D Total Ankle Replacement SystemParagon 28, Inc. · 2021
- Descendant · cites it directly · 2 of its ownK171004 Hintermann Series H2 Total Ankle SystemDt Medtech, LLC · 2017
- Descendant · 3 generations on · 1 of its ownK231231 MR Safety and Compatibility Testing and Labeling for Paragon 28…Paragon 28, Inc. · 2023
- Descendant · 2 generations on · 1 of its ownK202019 Maven Patient-Specific InstrumentationParagon 28, Inc. · 2021
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K192994Paragon 28 APEX 3D Total Ankle Replacement SystemParagon 28, Inc. · 2020 · cites it directly8descendants
- K210390Apex 3D Total Ankle Replacement SystemParagon 28, Inc. · 2021 · 2 generations on2descendants
- K171004Hintermann Series H2 Total Ankle SystemDt Medtech, LLC · 2017 · cites it directly2descendants
- K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc. · 2023 · 3 generations on1descendant
- K202019Maven Patient-Specific InstrumentationParagon 28, Inc. · 2021 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K920802 | Alvine Total Ankle | Depuy, Inc. | 1992 | — |
| −3 | K020541 | Agility Ankle Revision Prosthesis | Depuy, Inc. | 2002 | — |
| −2 | K051023 | Topez Total Ankle Replacement | Topez Orthopedics, Inc. | 2005 | 4 |
| −1 | K100886 | Inbone II Total Ankle Replacement | Wrightmedicaltechnologyinc | 2010 | 2 |
| 0 (this device) | K151459 | Integra Total Ankle Replacement System | Ascension Orthopedics | 2015 | — |
| +1 | K192994 | Paragon 28 APEX 3D Total Ankle Replacement System | Paragon 28, Inc. | 2020 | — |
| +2 | K210390 | Apex 3D Total Ankle Replacement System | Paragon 28, Inc. | 2021 | — |
| +1 | K171004 | Hintermann Series H2 Total Ankle System | Dt Medtech, LLC | 2017 | — |
| +3 | K231231 | MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic… | Paragon 28, Inc. | 2023 | — |
| +2 | K202019 | Maven Patient-Specific Instrumentation | Paragon 28, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2020 | 4 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 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 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 |
|---|---|---|---|
| * | K100886 | Inbone II Total Ankle ReplacementSummary page 7…K151459 page 4 of 4 Legally Marketed Predicate Device: Wright Medical INBONE™ Total Ankle System (K100886) Predicate Indications for Use: The Wright Medical INBONE™ Total Ankle System ( K100886) is indicated for patients with ankle j… | 2010 |
What descends from it? (14)
See all 144 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 20, 2017 | Class II | Z-1192-2017 | Use error | Posterior tibial fractures have been reported. |
| Apr 29, 2016 | Class II | Z-2086-2016 | Labeling mix-ups | As a result of an internal review of all labeling for the Cadence System, it was determined that the outer package label for the Size 5 Left Tibial Tray Implant reflects the material composition incorrectly. The labeling incorrectly… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 4 companies; a new generation was cleared every 5.0 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K192994 (Paragon 28, Inc., 2020) has gone furthest, with 8 descendants of its own.
- 7 other devices also cite its predicate K100886.
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. 2015, 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 Cadence Total Ankle System is designed to treat ankle arthritis through replacement of the ankle joint with a prosthesis, thereby reducing pain, restoring alignment, and allowing for movement at the replaced joint. The Cadence Total Ankle System is indicated for use to treat: ‐ systemic arthritis of the ankle (e.g. rheumatoid arthritis, hemochromatosis) ‐ primary arthritis (e.g. degenerative disease) ‐ secondary arthritis (e.g. post‐traumatic…
Read the full statement (115 words)
The Cadence Total Ankle System is designed to treat ankle arthritis through replacement of the ankle joint with a prosthesis, thereby reducing pain, restoring alignment, and allowing for movement at the replaced joint.
The Cadence Total Ankle System is indicated for use to treat:
‐ systemic arthritis of the ankle (e.g. rheumatoid arthritis, hemochromatosis)
‐ primary arthritis (e.g. degenerative disease)
‐ secondary arthritis (e.g. post‐traumatic, avascular necrosis, if minimally 2/3 of the talus is preserved)
The Cadence Total Ankle System is also indicated for revision surgeries following failed total ankle replacement and non‐union/mal‐union of ankle arthrodesis, provided sufficient bone stock is present.
Note: In the United States, this device is intended for cemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151459 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151459: Integra 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/K151459
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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