# K182878: Integra Salto Total Ankle System

- Pathway: 510(k) (Special)
- Applicant: Ascension Orthopedics
- Decided: Dec 18, 2018 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: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K984290 (1999). 18 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153452: Salto XT, Salto Talaris, Tornier S.A.S. (2016) Summary page 4.

## Most influential descendants
- K240591: restor3d Kinos Axiom Total Ankle System (2024), 0 descendants 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
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.

Source page: https://510kreport.com/device/K182878
Methodology: https://510kreport.com/methodology