# K130533: Salto Talaris Total Ankle Prosthesis, RHS - Pathway: 510(k) (Special) - Applicant: Tornier S.A.S. - Decided: May 17, 2013 after 77 days - Product code: HSN (Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer) - Device class: 2 - Regulation: 21 CFR 888.3110 - Recalls of this device: 19 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 5 generations back to K984290 (1999). 16 ancestors in all. 16 later devices descend from it; 2 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 2. - K090076: Salto Talaris Total Ankle Prosthesis, Tornier (2009) Summary page 2. - K920802: Alvine Total Ankle, Depuy, Inc. (1992) Summary page 2. - K020541: Agility Ankle Revision Prosthesis, Depuy, Inc. (2002) Summary page 2. - K051023: Topez Total Ankle Replacement, Topez Orthopedics, Inc. (2005) Summary page 2. - K994041: Tornier Bipolar Radial Head Prosthesis, Tornier, Inc. (2000) Summary page 2. - K060438: RHS, Tornier (2006) Summary page 2. - K023604: Modification to Radial Head Implant, Avanta Orthopaedics, Inc. (2002) Summary page 2. - K051385: Explor Modular Radial Head Replacement Device, Biomet, Inc. (2005) Summary page 2. ## Most influential descendants - 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 - 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 ## 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 - Aug 6, 2015 · Class II · Z-2465-2015: 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 S ## 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. 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. Source page: https://510kreport.com/device/K130533 Methodology: https://510kreport.com/methodology