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 Nov 13, 2006 as substantially equivalent to K920802 (Depuy, Inc., 1992) and 2 other predicates after a 257-day review. Its family tree reaches back 3 generations to 1992. 23 later devices descend from it. It has been recalled 18 times.
- Decided
- Nov 13, 2006
- Review
- 257 days
- Class
- Class II
- Product code
- HSN
- Recalls
- 18
- Predicates
- 3
Its longest line of descent runs back 3 generations to K920802 (1992). 23 later devices descend from it, 5 citing it directly.
- Root · 3 generations backK920802 Alvine Total AnkleDepuy, Inc. · 1992
- 2 generations backK020541 Agility Ankle Revision ProsthesisDepuy, Inc. · 2002
- 1 generation backK051023 Topez Total Ankle ReplacementTopez Orthopedics, Inc. · 2005 · Recalled
- This deviceK060544 Salto Talaris Total Ankle ProsthesisTornier · 2006
- Descendant · cites it directly · 21 of its ownK090076 Salto Talaris Total Ankle ProsthesisTornier · 2009 · Recalled
- 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 · 2 generations on · 7 of its ownK152217 Exactech Vantage Total Ankle SystemExactech, Inc. · 2016 · Recalled
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K090076Salto Talaris Total Ankle ProsthesisTornier · 2009 · cites it directly21descendants
- 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 · 2 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K920802 | Alvine Total Ankle | Depuy, Inc. | 1992 | — |
| −2 | K020541 | Agility Ankle Revision Prosthesis | Depuy, Inc. | 2002 | — |
| −1 | K051023 | Topez Total Ankle Replacement | Topez Orthopedics, Inc. | 2005 | 4 |
| 0 (this device) | K060544 | Salto Talaris Total Ankle Prosthesis | Tornier | 2006 | — |
| +1 | K090076 | Salto Talaris Total Ankle Prosthesis | Tornier | 2009 | 18 |
| +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 | — |
| +2 | K152217 | Exactech Vantage Total Ankle System | Exactech, Inc. | 2016 | 6 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 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? (3)
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 |
|---|---|---|---|
| * | K920802 | Alvine Total AnkleSummary page 4…n panel: Orthopedic Product code: 87HSN 5) Equivalent / Predicate device Alvine Total Ankle Prosthesis (Agility), DePuy, K920802, K020541 Topez Total Ankle Replacement, Topez Orthopedics, Inc., K051023 6) Device description The goal of total ankle replaceme… | 1992 |
| * | K020541 | Agility Ankle Revision ProsthesisSummary page 4…Orthopedic Product code: 87HSN 5) Equivalent / Predicate device 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 4…87HSN 5) Equivalent / Predicate device 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 Ankle… | 2005 |
What descends from it? (23)
See all 235 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 14 years and passes through 3 companies; a new generation was cleared every 3.5 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K090076 (Tornier, 2009) has gone furthest, with 21 descendants of its own.
- 5 other devices also cite its predicate K920802.
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.
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 SaIto Talaris Anatomic Ankle 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/K060544 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060544: 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/K060544
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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