510(k) · Cleared
Recalled · Class II · 2019Salto XT, Salto Talaris
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tornier S.A.S. · HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Cleared on Aug 11, 2016 as substantially equivalent to K060544 (Tornier, 2006) and 2 other predicates after a 255-day review. Its family tree reaches back 6 generations to 1999. 15 later devices descend from it. It has been recalled 8 times.
- Decided
- Aug 11, 2016
- Review
- 255 days
- Class
- Class II
- Product code
- HSN
- Recalls
- 8
- Predicates
- 3
Its longest line of descent runs back 6 generations to K984290 (1999). 17 ancestors in all, the oldest K920802 (1992). 15 later devices descend from it, 4 citing it directly.
- Root · 6 generations backK984290 Implex Radial Head Replacement SystemImplex Corp. · 1999
- 5 generations backK012551 Liverpool Radial Head Replacement DeviceBiomet, Inc. · 2002
- 4 generations backK040611 Modular Radial Head Replacement DeviceBiomet, Inc. · 2004 · Recalled
- 3 generations backK051385 Explor Modular Radial Head Replacement DeviceBiomet, Inc. · 2005 · Recalled
- 2 generations backK060438 RHSTornier · 2006
- 1 generation backK130533 Salto Talaris Total Ankle Prosthesis, RHSTornier S.A.S. · 2013 · Recalled
- This deviceK153452 Salto XT, Salto TalarisTornier S.A.S. · 2016
- Descendant · cites it directly · 8 of its ownK192994 Paragon 28 APEX 3D Total Ankle Replacement SystemParagon 28, Inc. · 2020
- Descendant · 2 generations on · 2 of its ownK210390 Apex 3D Total Ankle Replacement SystemParagon 28, Inc. · 2021
- Descendant · cites it directly · 2 of its ownK171004 Hintermann Series H2 Total Ankle SystemDt Medtech, LLC · 2017
- Descendant · 3 generations on · 1 of its ownK231231 MR Safety and Compatibility Testing and Labeling for Paragon 28…Paragon 28, Inc. · 2023
- Descendant · 2 generations on · 1 of its ownK202019 Maven Patient-Specific InstrumentationParagon 28, Inc. · 2021
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K192994Paragon 28 APEX 3D Total Ankle Replacement SystemParagon 28, Inc. · 2020 · cites it directly8descendants
- K210390Apex 3D Total Ankle Replacement SystemParagon 28, Inc. · 2021 · 2 generations on2descendants
- K171004Hintermann Series H2 Total Ankle SystemDt Medtech, LLC · 2017 · cites it directly2descendants
- K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc. · 2023 · 3 generations on1descendant
- K202019Maven Patient-Specific InstrumentationParagon 28, Inc. · 2021 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K984290 | Implex Radial Head Replacement System | Implex Corp. | 1999 | — |
| −5 | K012551 | Liverpool Radial Head Replacement Device | Biomet, Inc. | 2002 | — |
| −4 | K040611 | Modular Radial Head Replacement Device | Biomet, Inc. | 2004 | 1 |
| −3 | K051385 | Explor Modular Radial Head Replacement Device | Biomet, Inc. | 2005 | 2 |
| −2 | K060438 | RHS | Tornier | 2006 | — |
| −1 | K130533 | Salto Talaris Total Ankle Prosthesis, RHS | Tornier S.A.S. | 2013 | 19 |
| 0 (this device) | K153452 | Salto XT, Salto Talaris | Tornier S.A.S. | 2016 | — |
| +1 | K192994 | Paragon 28 APEX 3D Total Ankle Replacement System | Paragon 28, Inc. | 2020 | — |
| +2 | K210390 | Apex 3D Total Ankle Replacement System | Paragon 28, Inc. | 2021 | — |
| +1 | K171004 | Hintermann Series H2 Total Ankle System | Dt Medtech, LLC | 2017 | — |
| +3 | K231231 | MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic… | Paragon 28, Inc. | 2023 | — |
| +2 | K202019 | Maven Patient-Specific Instrumentation | Paragon 28, Inc. | 2021 | — |
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 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 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 |
|---|---|---|---|
| * | K060544 | Salto Talaris Total Ankle ProsthesisSummary page 5…lassification Device class: Class II Classification panel: Orthopedic Product code: HSN 5) Equivalent / Predicate device : Primary predicate: Salto Talaris, TORNIER, K060544, K090076, K130533. TORNIER S.A S. Tél. : 33 (0)4 76 61 35 00 S.A.S. au capital de 35 043 008 € r—.-1\ 161, rue Lavoisier Fax : 3… | 2006 |
| * | K090076 | Salto Talaris Total Ankle ProsthesisSummary page 5…tion Device class: Class II Classification panel: Orthopedic Product code: HSN 5) Equivalent / Predicate device : Primary predicate: Salto Talaris, TORNIER, K060544, K090076, K130533. TORNIER S.A S. Tél. : 33 (0)4 76 61 35 00 S.A.S. au capital de 35 043 008 € r—.-1\ 161, rue Lavoisier Fax : 33 (0)4 76… | 2009 |
| * | K130533 | Salto Talaris Total Ankle Prosthesis, RHSSummary page 5…ice class: Class II Classification panel: Orthopedic Product code: HSN 5) Equivalent / Predicate device : Primary predicate: Salto Talaris, TORNIER, K060544, K090076, K130533. TORNIER S.A S. Tél. : 33 (0)4 76 61 35 00 S.A.S. au capital de 35 043 008 € r—.-1\ 161, rue Lavoisier Fax : 33 (0)4 76 61 35 33… | 2013 |
| † | K100886 | Inbone II Total Ankle Replacement | 2010 |
| † | K103374 | Inbone Total Ankle System Model 200347902 | 2010 |
| † | K123059 | Inbone ( I and II) Total Ankle Systems | 2013 |
| † | K133585 | Inbone Total Ankle | 2014 |
| † | K123954 | Infinity Total Ankle System | 2013 |
| † | K140749 | Infinity Total Ankle System | 2014 |
| † | K020541 | Agility Ankle Revision Prosthesis | 2002 |
| † | K053569 | Agility LP Total Ankle Prosthesis | 2006 |
| † | K122395 | Depuy Agility LP Total Ankle Prosthesis | 2012 |
What descends from it? (15)
See all 154 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-1172-2019 | 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-1174-2019 | 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-1175-2019 | 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-1173-2019 | 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-1170-2019 | 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-1169-2019 | 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-1168-2019 | 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-1171-2019 | 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 8 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 4 companies; a new generation was cleared every 2.7 years on median.
- 10 of the 17 ancestors have a recall of any class.
- Of its descendants, K192994 (Paragon 28, Inc., 2020) has gone furthest, with 8 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. 2016, 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 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.
Components are intended for cemented use only.
The Salto XT ankle prosthesis is indicated as a total ankle replacement in revision surgeries only for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis.
Components are intended for cemented 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/K153452 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153452: Salto XT, Salto Talaris.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153452
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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