510(k) · Cleared
ClearedKinos Axiom Total Ankle System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Restor3D · HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Cleared on Nov 28, 2023 as substantially equivalent to K192778 (Kinos Medical, 2020) and 1 other predicate after a 95-day review. Its family tree reaches back 7 generations to 1992. 3 later devices descend from it.
- Decided
- Nov 28, 2023
- Review
- 95 days
- Class
- Class II
- Product code
- HSN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K920802 (1992). 9 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK920802 Alvine Total AnkleDepuy, Inc. · 1992
- 6 generations backK020541 Agility Ankle Revision ProsthesisDepuy, Inc. · 2002
- 5 generations backK051023 Topez Total Ankle ReplacementTopez Orthopedics, Inc. · 2005 · Recalled
- 4 generations backK100886 Inbone II Total Ankle ReplacementWrightmedicaltechnologyinc · 2010 · Recalled
- 3 generations backK123954 Infinity Total Ankle SystemWrightmedicaltechnologyinc · 2013 · Recalled
- 2 generations backK140749 Infinity Total Ankle SystemWrightmedicaltechnologyinc · 2014 · Recalled
- 1 generation backK192778 Kinos Axiom Total Ankle SystemKinos Medical · 2020
- This deviceK232595 Kinos Axiom Total Ankle SystemRestor3D · 2023
- Descendant · cites it directly · 2 of its ownK241482 Kinos Total Ankle SystemRestor3D · 2024
- Descendant · 2 generations on · 1 of its ownK242868 Kinos Total Ankle SystemRestor3D · 2024
- Descendant · 3 generations on · 0 of its ownK252454 Kinos Total Ankle SystemRestor3D · 2025
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K920802 | Alvine Total Ankle | Depuy, Inc. | 1992 | — |
| −6 | K020541 | Agility Ankle Revision Prosthesis | Depuy, Inc. | 2002 | — |
| −5 | K051023 | Topez Total Ankle Replacement | Topez Orthopedics, Inc. | 2005 | 4 |
| −4 | K100886 | Inbone II Total Ankle Replacement | Wrightmedicaltechnologyinc | 2010 | 2 |
| −3 | K123954 | Infinity Total Ankle System | Wrightmedicaltechnologyinc | 2013 | 2 |
| −2 | K140749 | Infinity Total Ankle System | Wrightmedicaltechnologyinc | 2014 | 1 |
| −1 | K192778 | Kinos Axiom Total Ankle System | Kinos Medical | 2020 | — |
| 0 (this device) | K232595 | Kinos Axiom Total Ankle System | Restor3D | 2023 | — |
| +1 | K241482 | Kinos Total Ankle System | Restor3D | 2024 | — |
| +2 | K242868 | Kinos Total Ankle System | Restor3D | 2024 | — |
| +3 | K252454 | Kinos Total Ankle System | Restor3D | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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? (2)
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 |
|---|---|---|---|
| * | K192778 | Kinos Axiom Total Ankle SystemSummary page 6…10(k) Trade Name Manufacturer Primary Predicate Device Restor3d, Inc. K192778 Kinos Axiom Total Ankle System Cleared under Kinos… | 2020 |
| * | K140749 | Infinity Total Ankle SystemSummary page 6…Cleared under Kinos Medical Secondary Predicate Device K140749 Infinity Total Ankle System Wright Medical Reference Device K220523 restor3d TiDAL Lumbar Interbody… | 2014 |
| † | K220523 | restor3d TiDAL Lumbar Interbody Fusion Device | 2022 |
| † | K210390 | Apex 3D Total Ankle Replacement System | 2021 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241482 | Kinos Total Ankle System | 2024 | 2 |
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 31 years and passes through 5 companies; a new generation was cleared every 3.5 years on median.
- 4 of the 9 ancestors have a recall of any class.
- Of its descendants, K241482 (Restor3D, 2024) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K192778.
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. 2023, 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 Kinos Axiom Total Ankle System is indicated for patients with ankle joints damaged by severe rheumatoid, posttraumatic, or degenerative arthritis. The Kinos Total Ankle System is additionally indicated for patients with failed previous ankle surgery. The Kinos Axiom Total Ankle System is intended for cement 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/K232595 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232595: Kinos Axiom Total Ankle System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232595
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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