510(k) · Cleared
Recalled · Class II · 2019Salto Talaris Total Ankle Prosthesis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tornier · HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Cleared on Mar 17, 2009 as substantially equivalent to K060544 (Tornier, 2006) and 3 other predicates after a 64-day review. Its family tree reaches back 4 generations to 1992. 21 later devices descend from it. It has been recalled 18 times.
- Decided
- Mar 17, 2009
- Review
- 64 days
- Class
- Class II
- Product code
- HSN
- Recalls
- 18
- Predicates
- 4
Its longest line of descent runs back 4 generations to K920802 (1992). 21 later devices descend from it, 5 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 backK060544 Salto Talaris Total Ankle ProsthesisTornier · 2006 · Recalled
- This deviceK090076 Salto Talaris Total Ankle ProsthesisTornier · 2009
- Descendant · cites it directly · 16 of its ownK130533 Salto Talaris Total Ankle Prosthesis, RHSTornier S.A.S. · 2013 · Recalled
- Descendant · cites it directly · 15 of its ownK153452 Salto XT, Salto TalarisTornier S.A.S. · 2016 · Recalled
- Descendant · 2 generations on · 8 of its ownK192994 Paragon 28 APEX 3D Total Ankle Replacement SystemParagon 28, Inc. · 2020
- Descendant · cites it directly · 7 of its ownK152217 Exactech Vantage Total Ankle SystemExactech, Inc. · 2016 · Recalled
- Descendant · 3 generations on · 2 of its ownK210390 Apex 3D Total Ankle Replacement SystemParagon 28, Inc. · 2021
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K130533Salto Talaris Total Ankle Prosthesis, RHSTornier S.A.S. · 2013 · cites it directly16descendants
- K153452Salto XT, Salto TalarisTornier S.A.S. · 2016 · cites it directly15descendants
- K192994Paragon 28 APEX 3D Total Ankle Replacement SystemParagon 28, Inc. · 2020 · 2 generations on8descendants
- K152217Exactech Vantage Total Ankle SystemExactech, Inc. · 2016 · cites it directly7descendants
- K210390Apex 3D Total Ankle Replacement SystemParagon 28, Inc. · 2021 · 3 generations on2descendants
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 | K060544 | Salto Talaris Total Ankle Prosthesis | Tornier | 2006 | 18 |
| 0 (this device) | K090076 | Salto Talaris Total Ankle Prosthesis | Tornier | 2009 | — |
| +1 | K130533 | Salto Talaris Total Ankle Prosthesis, RHS | Tornier S.A.S. | 2013 | 19 |
| +1 | K153452 | Salto XT, Salto Talaris | Tornier S.A.S. | 2016 | 8 |
| +2 | K192994 | Paragon 28 APEX 3D Total Ankle Replacement System | Paragon 28, Inc. | 2020 | — |
| +1 | K152217 | Exactech Vantage Total Ankle System | Exactech, Inc. | 2016 | 6 |
| +3 | K210390 | Apex 3D Total Ankle Replacement System | Paragon 28, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 4 | 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? (4)
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 |
|---|---|---|---|
| * | K060544 | Salto Talaris Total Ankle ProsthesisSummary page 1…Class II Classification panel: Orthopedic Product code: 87 HSN 5) Equivalent / Predicate device Salto Talaris Total Ankle Prosthesis, Tornier, K060544 Alvine Total Ankle Prosthesis (Agility), DePuy, K920802, K020541 Topez Total Ankle Replacement, Topez Orthopedics, Inc., K051023… | 2006 |
| * | K920802 | Alvine Total AnkleSummary page 1…Product code: 87 HSN 5) Equivalent / Predicate device Salto Talaris Total Ankle Prosthesis, Tornier, K060544 Alvine Total Ankle Prosthesis (Agility), DePuy, K920802, K020541 Topez Total Ankle Replacement, Topez Orthopedics, Inc., K051023 6) Device description The, goal of total ankle replacem… | 1992 |
| * | K020541 | Agility Ankle Revision ProsthesisSummary page 1…code: 87 HSN 5) Equivalent / Predicate device Salto Talaris Total Ankle Prosthesis, Tornier, K060544 Alvine Total Ankle Prosthesis (Agility), DePuy, K920802, K020541 Topez Total Ankle Replacement, Topez Orthopedics, Inc., K051023 6) Device description The, goal of total ankle replacement is to… | 2002 |
| * | K051023 | Topez Total Ankle ReplacementSummary page 1…Talaris Total Ankle Prosthesis, Tornier, K060544 Alvine Total Ankle Prosthesis (Agility), DePuy, K920802, K020541 Topez Total Ankle Replacement, Topez Orthopedics, Inc., K051023 6) Device description The, goal of total ankle replacement is to restore function and relieve pain. The Salto Talaris Total Ankl… | 2005 |
What descends from it? (21)
See all 215 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 |
|---|---|---|---|---|
| Mar 8, 2019 | Class II | Z-1163-2019 | Other | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and IFU |
| Mar 8, 2019 | Class II | Z-1152-2019 | Other | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and IFU |
| Mar 8, 2019 | Class II | Z-1160-2019 | Other | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and IFU |
| Mar 8, 2019 | Class II | Z-1165-2019 | Other | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and IFU |
| Mar 8, 2019 | Class II | Z-1153-2019 | Other | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and IFU |
| Mar 8, 2019 | Class II | Z-1162-2019 | Other | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and IFU |
| Mar 8, 2019 | Class II | Z-1166-2019 | Other | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and IFU |
| Mar 8, 2019 | Class II | Z-1159-2019 | Other | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and IFU |
| Mar 8, 2019 | Class II | Z-1156-2019 | Other | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and IFU |
| Mar 8, 2019 | Class II | Z-1167-2019 | Other | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and IFU |
| Mar 8, 2019 | Class II | Z-1164-2019 | Other | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and IFU |
| Mar 8, 2019 | Class II | Z-1151-2019 | Other | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and IFU |
| Mar 8, 2019 | Class II | Z-1161-2019 | Other | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and IFU |
| Mar 8, 2019 | Class II | Z-1150-2019 | Other | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and IFU |
| Mar 8, 2019 | Class II | Z-1158-2019 | Other | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and IFU |
| Mar 8, 2019 | Class II | Z-1157-2019 | Other | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and IFU |
| Mar 8, 2019 | Class II | Z-1155-2019 | Other | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and IFU |
| Mar 8, 2019 | Class II | Z-1154-2019 | Other | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and IFU |
The 5 latest of 18 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 3.5 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K130533 (Tornier S.A.S., 2013) has gone furthest, with 16 descendants of its own.
- 4 other devices also cite its predicate K060544.
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. 2009, 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 Salto Talaris Total Ankle Prosthesis is indicated as a total ankle replacement in primary or revision surgery for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis.
All components are intended for cemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090076 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090076: Salto Talaris Total Ankle Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090076
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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