510(k) · Cleared
ClearedKinos 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 Jul 22, 2024 as substantially equivalent to K232595 (Restor3D, 2023) after a 59-day review. Its family tree reaches back 8 generations to 1992. 2 later devices descend from it.
- Decided
- Jul 22, 2024
- Review
- 59 days
- Class
- Class II
- Product code
- HSN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K920802 (1992). 10 ancestors in all. 2 later devices descend from it, 1 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 backK192778 Kinos Axiom Total Ankle SystemKinos Medical · 2020
- 1 generation backK232595 Kinos Axiom Total Ankle SystemRestor3D · 2023
- This deviceK241482 Kinos Total Ankle SystemRestor3D · 2024
- Descendant · cites it directly · 1 of its ownK242868 Kinos Total Ankle SystemRestor3D · 2024
- Descendant · 2 generations on · 0 of its ownK252454 Kinos Total Ankle SystemRestor3D · 2025
Most influential descendants
Showing 2 of 2 · See allView 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 | K192778 | Kinos Axiom Total Ankle System | Kinos Medical | 2020 | — |
| −1 | K232595 | Kinos Axiom Total Ankle System | Restor3D | 2023 | — |
| 0 (this device) | K241482 | Kinos Total Ankle System | Restor3D | 2024 | — |
| +1 | K242868 | Kinos Total Ankle System | Restor3D | 2024 | — |
| +2 | 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 | 1 | 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 |
|---|---|---|---|
| * | K232595 | Kinos Axiom Total Ankle SystemSummary page 5…ng devices: 510(k) Trade Name Manufacturer Primary Predicate Device Kinos Axiom Total Ankle K232595 restor3d, Inc. System Reference Devices… | 2023 |
| † | K192778 | Kinos Axiom Total Ankle System | 2020 |
| † | K113828 | Dynanail Ankle Arthrodesis Nail | 2012 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242868 | Kinos Total Ankle System | 2024 | 1 |
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 5 companies; a new generation was cleared every 3.5 years on median.
- 4 of the 10 ancestors have a recall of any class.
- Of its descendants, K242868 (Restor3D, 2024) has gone furthest, with 1 descendant of its own.
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 r3 Tibial Implants of the Kinos Total Ankle System are indicated for revision total ankle arthroplasty. The Kinos Total Ankle System is intended for cement use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241482 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241482: Kinos 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/K241482
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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