510(k) · Cleared
Recalled · Class II · 2019Salto Talaris Total Ankle Prosthesis, RHS
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 May 17, 2013 as substantially equivalent to K060544 (Tornier, 2006) and 8 other predicates after a 77-day review. Its family tree reaches back 5 generations to 1999. 16 later devices descend from it. It has been recalled 19 times.
- Decided
- May 17, 2013
- Review
- 77 days
- Class
- Class II
- Product code
- HSN
- Recalls
- 19
- Predicates
- 9
Its longest line of descent runs back 5 generations to K984290 (1999). 16 ancestors in all, the oldest K920802 (1992). 16 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK984290 Implex Radial Head Replacement SystemImplex Corp. · 1999
- 4 generations backK012551 Liverpool Radial Head Replacement DeviceBiomet, Inc. · 2002
- 3 generations backK040611 Modular Radial Head Replacement DeviceBiomet, Inc. · 2004 · Recalled
- 2 generations backK051385 Explor Modular Radial Head Replacement DeviceBiomet, Inc. · 2005 · Recalled
- 1 generation backK060438 RHSTornier · 2006
- This deviceK130533 Salto Talaris Total Ankle Prosthesis, RHSTornier S.A.S. · 2013
- 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 · 3 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 · 4 generations on · 1 of its ownK231231 MR Safety and Compatibility Testing and Labeling for Paragon 28…Paragon 28, Inc. · 2023
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- 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
- K210390Apex 3D Total Ankle Replacement SystemParagon 28, Inc. · 2021 · 3 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 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K984290 | Implex Radial Head Replacement System | Implex Corp. | 1999 | — |
| −4 | K012551 | Liverpool Radial Head Replacement Device | Biomet, Inc. | 2002 | — |
| −3 | K040611 | Modular Radial Head Replacement Device | Biomet, Inc. | 2004 | 1 |
| −2 | K051385 | Explor Modular Radial Head Replacement Device | Biomet, Inc. | 2005 | 2 |
| −1 | K060438 | RHS | Tornier | 2006 | — |
| 0 (this device) | K130533 | Salto Talaris Total Ankle Prosthesis, RHS | Tornier S.A.S. | 2013 | — |
| +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 | — |
| +3 | K210390 | Apex 3D Total Ankle Replacement System | Paragon 28, Inc. | 2021 | — |
| +1 | K171004 | Hintermann Series H2 Total Ankle System | Dt Medtech, LLC | 2017 | — |
| +4 | K231231 | MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic… | Paragon 28, Inc. | 2023 | — |
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 |
|---|---|---|
| 2016 | 1 | 0 |
| 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? (9)
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 2…code: JOB & KWI 6) Equivalent / Predicate device For the Salto Talaris Total Ankle Prosthesis: Salto Talaris Total Ankle Prosthesis, Tornier. K060544, K090076 Alvine Total Ankle Prosthesis (Agility), DePuy. K920802, K020541 Topez Total Ankle Replacement, Topez Orthop… | 2006 |
| * | K090076 | Salto Talaris Total Ankle ProsthesisSummary page 2…JOB & KWI 6) Equivalent / Predicate device For the Salto Talaris Total Ankle Prosthesis: Salto Talaris Total Ankle Prosthesis, Tornier. K060544, K090076 Alvine Total Ankle Prosthesis (Agility), DePuy. K920802, K020541 Topez Total Ankle Replacement, Topez Orthopedics, In… | 2009 |
| * | K920802 | Alvine Total AnkleSummary page 2…For the Salto Talaris Total Ankle Prosthesis: Salto Talaris Total Ankle Prosthesis, Tornier. K060544, K090076 Alvine Total Ankle Prosthesis (Agility), DePuy. K920802, K020541 Topez Total Ankle Replacement, Topez Orthopedics, Inc., K05 1023 For the RHS: Radial Head Prosthesis,… | 1992 |
| * | K020541 | Agility Ankle Revision ProsthesisSummary page 2…alto Talaris Total Ankle Prosthesis: Salto Talaris Total Ankle Prosthesis, Tornier. K060544, K090076 Alvine Total Ankle Prosthesis (Agility), DePuy. K920802, K020541 Topez Total Ankle Replacement, Topez Orthopedics, Inc., K05 1023 For the RHS: Radial Head Prosthesis, Tornier,… | 2002 |
| * | K051023 | Topez Total Ankle ReplacementSummary page 2…rosthesis, Tornier. K060544, K090076 Alvine Total Ankle Prosthesis (Agility), DePuy. K920802, K020541 Topez Total Ankle Replacement, Topez Orthopedics, Inc., K05 1023 For the RHS: Radial Head Prosthesis, Tornier, K994041, K060438 Radial Head, Avanta, K023604 Explor, Biom… | 2005 |
| * | K994041 | Tornier Bipolar Radial Head ProsthesisSummary page 2…esis (Agility), DePuy. K920802, K020541 Topez Total Ankle Replacement, Topez Orthopedics, Inc., K05 1023 For the RHS: Radial Head Prosthesis, Tornier, K994041, K060438 Radial Head, Avanta, K023604 Explor, Biomet. K051385 7) Device description For the Salto Talar… | 2000 |
| * | K060438 | RHSSummary page 2…lity), DePuy. K920802, K020541 Topez Total Ankle Replacement, Topez Orthopedics, Inc., K05 1023 For the RHS: Radial Head Prosthesis, Tornier, K994041, K060438 Radial Head, Avanta, K023604 Explor, Biomet. K051385 7) Device description For the Salto Talaris Total… | 2006 |
| * | K023604 | Modification to Radial Head ImplantSummary page 2…Topez Total Ankle Replacement, Topez Orthopedics, Inc., K05 1023 For the RHS: Radial Head Prosthesis, Tornier, K994041, K060438 Radial Head, Avanta, K023604 Explor, Biomet. K051385 7) Device description For the Salto Talaris Total Ankle Prosthesis: The goal of… | 2002 |
| * | K051385 | Explor Modular Radial Head Replacement DeviceSummary page 2…t, Topez Orthopedics, Inc., K05 1023 For the RHS: Radial Head Prosthesis, Tornier, K994041, K060438 Radial Head, Avanta, K023604 Explor, Biomet. K051385 7) Device description For the Salto Talaris Total Ankle Prosthesis: The goal of total ankle replacement is to… | 2005 |
What descends from it? (16)
See all 162 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 |
| Aug 6, 2015 | Class II | Z-2465-2015 | Nonconforming Material/Component | Tornier has initiated a voluntary recall for the Salto Talaris Tibial Guide (part number MJU333) due to a complaint that occurred during physician training, that the guide cannot be assembled to the Salto Talaris Talar Pin Setting guide.… |
The 5 latest of 19 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 4 companies; a new generation was cleared every 2.3 years on median.
- 9 of the 16 ancestors have a recall of any class.
- Of its descendants, K153452 (Tornier S.A.S., 2016) has gone furthest, with 15 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. 2013, 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?
Salto Talaris Total Ankle Prosthesis: 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. Components are intended for cemented use only. RHS: The RHS is intended for: 1) Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation and decreased…
Read the full statement (134 words)
Salto Talaris Total Ankle Prosthesis:
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.
Components are intended for cemented use only.
RHS:
The RHS is intended for:
1) Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with:
a. Joint destruction and/or subluxation visible on x-ray
b. Resistance to conservative treatment
2) Primary replacement after fracture of the radial head
3) Symptomatic sequelae after radial head resection
4) Revision following failed radial head arthroplasty
The long stem is for single cemented use only. The short stem coated with titanium plasma-spray is for single use with or without cement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130533 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130533: Salto Talaris Total Ankle Prosthesis, RHS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130533
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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