# K090076: Salto Talaris Total Ankle Prosthesis

- Pathway: 510(k) (Special)
- Applicant: Tornier
- Decided: Mar 17, 2009 after 64 days
- Product code: HSN (Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3110
- Recalls of this device: 18 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K920802 (1992). 4 ancestors in all.
21 later devices descend from it; 5 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060544: Salto Talaris Total Ankle Prosthesis, Tornier (2006) Summary page 1.
- K920802: Alvine Total Ankle, Depuy, Inc. (1992) Summary page 1.
- K020541: Agility Ankle Revision Prosthesis, Depuy, Inc. (2002) Summary page 1.
- K051023: Topez Total Ankle Replacement, Topez Orthopedics, Inc. (2005) Summary page 1.

## Most influential descendants
- K130533: Salto Talaris Total Ankle Prosthesis, RHS (2013), 16 descendants of its own
- K153452: Salto XT, Salto Talaris (2016), 15 descendants of its own
- K192994: Paragon 28 APEX 3D Total Ankle Replacement System (2020), 8 descendants of its own
- K152217: Exactech Vantage Total Ankle System (2016), 7 descendants of its own
- K210390: Apex 3D Total Ankle Replacement System (2021), 2 descendants of its own

## Recalls of this device
- Mar 8, 2019 · Class II · Z-1163-2019: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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

## Indications for use
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.

Source page: https://510kreport.com/device/K090076
Methodology: https://510kreport.com/methodology