# K153452: Salto XT, Salto Talaris

- Pathway: 510(k) (Traditional)
- Applicant: Tornier S.A.S.
- Decided: Aug 11, 2016 after 255 days
- Product code: HSN (Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3110
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K984290 (1999). 17 ancestors in all.
15 later devices descend from it; 4 cite it directly.
0 of 33 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 5.
- K090076: Salto Talaris Total Ankle Prosthesis, Tornier (2009) Summary page 5.
- K130533: Salto Talaris Total Ankle Prosthesis, RHS, Tornier S.A.S. (2013) Summary page 5.

## Most influential descendants
- K192994: Paragon 28 APEX 3D Total Ankle Replacement System (2020), 8 descendants of its own
- K210390: Apex 3D Total Ankle Replacement System (2021), 2 descendants of its own
- K171004: Hintermann Series H2 Total Ankle System (2017), 2 descendants of its own
- K231231: MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation Devices (2023), 1 descendant of its own
- K202019: Maven Patient-Specific Instrumentation (2021), 1 descendant of its own

## Recalls of this device
- Mar 8, 2019 · Class II · Z-1172-2019: 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-1174-2019: 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-1175-2019: 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-1173-2019: 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-1170-2019: 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-1169-2019: 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-1168-2019: 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-1171-2019: 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 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.

Source page: https://510kreport.com/device/K153452
Methodology: https://510kreport.com/methodology