510(k) · Cleared
Recalled · Class II · 2019Integra Salto Total Ankle System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ascension Orthopedics · HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Cleared on Dec 18, 2018 as substantially equivalent to K153452 (Tornier S.A.S., 2016) after a 64-day review. Its family tree reaches back 7 generations to 1999. 1 later device descends from it. It has been recalled 8 times.
- Decided
- Dec 18, 2018
- Review
- 64 days
- Class
- Class II
- Product code
- HSN
- Recalls
- 8
- Predicates
- 1
Its longest line of descent runs back 7 generations to K984290 (1999). 18 ancestors in all, the oldest K920802 (1992). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK984290 Implex Radial Head Replacement SystemImplex Corp. · 1999
- 6 generations backK012551 Liverpool Radial Head Replacement DeviceBiomet, Inc. · 2002
- 5 generations backK040611 Modular Radial Head Replacement DeviceBiomet, Inc. · 2004 · Recalled
- 4 generations backK051385 Explor Modular Radial Head Replacement DeviceBiomet, Inc. · 2005 · Recalled
- 3 generations backK060438 RHSTornier · 2006
- 2 generations backK130533 Salto Talaris Total Ankle Prosthesis, RHSTornier S.A.S. · 2013 · Recalled
- 1 generation backK153452 Salto XT, Salto TalarisTornier S.A.S. · 2016 · Recalled
- This deviceK182878 Integra Salto Total Ankle SystemAscension Orthopedics · 2018
- Descendant · cites it directly · 0 of its ownK240591 restor3d Kinos Axiom Total Ankle SystemRestor3D, Inc. · 2024
Most influential descendants
Showing 1 of 1 · See all- K240591restor3d Kinos Axiom Total Ankle SystemRestor3D, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K984290 | Implex Radial Head Replacement System | Implex Corp. | 1999 | — |
| −6 | K012551 | Liverpool Radial Head Replacement Device | Biomet, Inc. | 2002 | — |
| −5 | K040611 | Modular Radial Head Replacement Device | Biomet, Inc. | 2004 | 1 |
| −4 | K051385 | Explor Modular Radial Head Replacement Device | Biomet, Inc. | 2005 | 2 |
| −3 | K060438 | RHS | Tornier | 2006 | — |
| −2 | 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 |
| 0 (this device) | K182878 | Integra Salto Total Ankle System | Ascension Orthopedics | 2018 | — |
| +1 | 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 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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? (1)
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 |
|---|---|---|---|
| * | K153452 | Salto XT, Salto TalarisSummary page 4…me Ankle Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulation 21 CFR 888.3110 Product Code HSN Predicate Device K153452: Salto Talaris, Salto XT Reference Device K151459: Integra Cadence Total Ankle Replacement System Device Description… | 2016 |
| † | K151459 | Integra Total Ankle Replacement System | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240591 | restor3d Kinos Axiom Total Ankle System | 2024 | 0 |
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 19 years and passes through 5 companies; a new generation was cleared every 2.4 years on median.
- 11 of the 18 ancestors have a recall of any class.
- Of its descendants, K240591 (Restor3D, Inc., 2024) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K153452.
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. 2018, 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.
Integra XT Revision Ankle Replacement System: The Integra XT Revision Ankle Replacement System 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/K182878 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182878: Integra Salto 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/K182878
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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