510(k) · Cleared
Clearedrestor3d Kinos Axiom Total Ankle System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Restor3D, Inc. · HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Cleared on Apr 29, 2024 as substantially equivalent to K123954 (Wrightmedicaltechnologyinc, 2013) and 1 other predicate after a 59-day review. Its family tree reaches back 8 generations to 1999.
- Decided
- Apr 29, 2024
- Review
- 59 days
- Class
- Class II
- Product code
- HSN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K984290 (1999). 23 ancestors in all, the oldest K920802 (1992). No later device cites it as a predicate yet.
- Root · 8 generations backK984290 Implex Radial Head Replacement SystemImplex Corp. · 1999
- 7 generations backK012551 Liverpool Radial Head Replacement DeviceBiomet, Inc. · 2002
- 6 generations backK040611 Modular Radial Head Replacement DeviceBiomet, Inc. · 2004 · Recalled
- 5 generations backK051385 Explor Modular Radial Head Replacement DeviceBiomet, Inc. · 2005 · Recalled
- 4 generations backK060438 RHSTornier · 2006
- 3 generations backK130533 Salto Talaris Total Ankle Prosthesis, RHSTornier S.A.S. · 2013 · Recalled
- 2 generations backK153452 Salto XT, Salto TalarisTornier S.A.S. · 2016 · Recalled
- 1 generation backK182878 Integra Salto Total Ankle SystemAscension Orthopedics · 2018 · Recalled
- This deviceK240591 restor3d Kinos Axiom Total Ankle SystemRestor3D, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K984290 | Implex Radial Head Replacement System | Implex Corp. | 1999 | — |
| −7 | K012551 | Liverpool Radial Head Replacement Device | Biomet, Inc. | 2002 | — |
| −6 | K040611 | Modular Radial Head Replacement Device | Biomet, Inc. | 2004 | 1 |
| −5 | K051385 | Explor Modular Radial Head Replacement Device | Biomet, Inc. | 2005 | 2 |
| −4 | K060438 | RHS | Tornier | 2006 | — |
| −3 | K130533 | Salto Talaris Total Ankle Prosthesis, RHS | Tornier S.A.S. | 2013 | 19 |
| −2 | K153452 | Salto XT, Salto Talaris | Tornier S.A.S. | 2016 | 8 |
| −1 | K182878 | Integra Salto Total Ankle System | Ascension Orthopedics | 2018 | 8 |
| 0 (this device) | K240591 | restor3d Kinos Axiom Total Ankle System | Restor3D, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | K123954 | Infinity Total Ankle SystemSummary page 5…Trade Name Manufacturer Primary Predicate Device INFINITY Total Ankle Wright Medical Technology, K123954 System Inc. Secondary Predicate Device SAL… | 2013 |
| * | K182878 | Integra Salto Total Ankle SystemSummary page 5…gy, K123954 System Inc. Secondary Predicate Device SALTO TALARIS Total K182878 Smith and Nephew, Inc. Ankle Prosthesis Reference Devi… | 2018 |
| † | K192778 | Kinos Axiom Total Ankle System | 2020 |
| † | K223316 | Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate… | 2023 |
| † | K203447 | iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity… | 2020 |
| † | K201393 | restor3d MTP Implant | 2022 |
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 25 years and passes through 6 companies; a new generation was cleared every 2.7 years on median.
- 14 of the 23 ancestors have a recall of any class.
- 10 other devices also cite its predicate K123954.
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 restor3d Kinos Axiom Total Ankle System is indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. The restor3d Kinos Total Ankle System is additionally indicated for patients with failed previous ankle surgery. The restor3d Kinos Axiom Total Ankle System is intended for cement use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240591 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240591: restor3d 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/K240591
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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