Salto Talaris Total Ankle Prosthesis
Salto TAL Talar Implant SZ 3 Right Cement USE Only
1manufacturer
94catalogue numbers in this listing
Who Else Makes It
Registered in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
Record
| Listed by | Smith & Nephew, Inc., United States |
|---|---|
| FDA product code | HSN |
| Device type | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3110 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K060544 |
| Record published | 2022-12-21 |
| Record revised | 2023-09-07 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LJU256T | In distribution | |
| LJU280T | In distribution | |
| LJU215T | In distribution | |
| LJU271T | In distribution | |
| LJV220T | In distribution | |
| LJU239T | In distribution | |
| LJU276T | In distribution | |
| LJU423T | In distribution | |
| LJU248T | In distribution | |
| LJU269T | In distribution | |
| LJU258T | In distribution | |
| LJU288T | In distribution | |
| LJU250T | In distribution | |
| LJU268T | In distribution | |
| LJU241T | In distribution | |
| LJV221T | In distribution | |
| LJU408T | In distribution | |
| LJU203T | In distribution | |
| LJU240T | In distribution | |
| LJU255T | In distribution | |
| LJU217T | In distribution | |
| LJU218T | In distribution | |
| LJU419T | In distribution | |
| LJU285T | In distribution | |
| LJU200T | In distribution | |
| LJU414T | In distribution | |
| LJU261T | In distribution | |
| LJU230T | In distribution | |
| LJV219T | In distribution | |
| LJU266T | In distribution | |
| LJU277T | In distribution | |
| LJU287T | In distribution | |
| LJU421T | In distribution | |
| LJU237T | In distribution | |
| LJU411T | In distribution | |
| LJU281T | In distribution | |
| LJU820T | In distribution | |
| LJU227T | In distribution | |
| LJU270T | In distribution | |
| LJU291T | In distribution | |
| LJU202T | In distribution | |
| LJU409T | In distribution | |
| LJU229T | In distribution | |
| LJU275T | In distribution | |
| LJU210T | In distribution | |
| LJU246T | In distribution | |
| LJU413T | In distribution | |
| LJU422T | In distribution | |
| LJU823T | In distribution | |
| LJU201T | In distribution | |
| LJU420T | In distribution | |
| LJU211T | In distribution | |
| LJU410T | In distribution | |
| LJU418T | In distribution | |
| LJU226T | In distribution | |
| LJU245T | In distribution | |
| LJU251T | In distribution | |
| LJU221T | In distribution | |
| LJU236T | In distribution | |
| LJU813T | In distribution | |
| LJU267T | In distribution | |
| LJU412T | In distribution | |
| LJU290T | In distribution | |
| LJU993T | In distribution | |
| LJU821T | In distribution | |
| LJU992T | In distribution | |
| LJU231T | In distribution | |
| LJU238T | In distribution | |
| LJU259T | In distribution | |
| LJU278T | In distribution | |
| LJU220T | In distribution | |
| LJU257T | In distribution | |
| LJU223T | In distribution | |
| LJU286T | In distribution | |
| LJU810T | In distribution | |
| LJU279T | In distribution | |
| LJU811T | In distribution | |
| LJU289T | In distribution | |
| LJU991T | In distribution | |
| LJU247T | In distribution | |
| LJU213T | In distribution | |
| LJU249T | In distribution | |
| LJU235T | In distribution | |
| LJU812T | In distribution | |
| LJU216T | In distribution | |
| LJU228T | In distribution | |
| LJU990T | In distribution | |
| LJU212T | In distribution | |
| LJU222T | In distribution | |
| LJU424T | In distribution | |
| LJU822T | In distribution | |
| LJU260T | In distribution | |
| LJU225T | In distribution | |
| LJU265T | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Apex 3D Total Ankle Replacement System | Paragon 28 | 658 |
| Vantage | Exactech, Inc. | 362 |
| Cadence™ | Ascension Orthopedics, Inc. | 248 |
| Cadence Total Ankle System | Smith & Nephew, Inc. | 246 |
| Inbone | Wright Medical Technology, Inc. | 236 |
| Hintermann Series H2 | DT Medtech LLC | 225 |
| Infinity | Wright Medical Technology, Inc. | 220 |
| Incompass Total Ankle System | Wright Medical Technology, Inc. | 213 |
| Invision | Wright Medical Technology, Inc. | 186 |
| Kinos Axiom Instrumentation | restor3d, inc. | 169 |
| Quantum | In2Bones SAS | 157 |
| Hintermann Series H2 | Vilex LLC | 153 |
Showing 12 of 53. All products under Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Recalls Naming This Product
27 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Integra Lifesciences Corporation | 510(k) number | 2019-03-08 | Class II | 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 | 2029 | 2020-05-15 |
| Integra Lifesciences Corporation | 510(k) number | 2019-03-08 | Class II | 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 | 2029 | 2020-05-15 |
| Integra Lifesciences Corporation | 510(k) number | 2019-03-08 | Class II | 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 | 2029 | 2020-05-15 |
| Integra Lifesciences Corporation | 510(k) number | 2019-03-08 | Class II | 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 | 2029 | 2020-05-15 |
| Integra Lifesciences Corporation | 510(k) number | 2019-03-08 | Class II | 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 | 2029 | 2020-05-15 |
| Integra Lifesciences Corporation | 510(k) number | 2019-03-08 | Class II | 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 | 2029 | 2020-05-15 |
| Integra Lifesciences Corporation | 510(k) number | 2019-03-08 | Class II | 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 | 2029 | 2020-05-15 |
| Integra Lifesciences Corporation | 510(k) number | 2019-03-08 | Class II | 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 | 2029 | 2020-05-15 |
| Integra Lifesciences Corporation | 510(k) number | 2019-03-08 | Class II | 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 | 2029 | 2020-05-15 |
| Integra Lifesciences Corporation | 510(k) number | 2019-03-08 | Class II | 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 | 2029 | 2020-05-15 |
| Integra Lifesciences Corporation | 510(k) number | 2019-03-08 | Class II | 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 | 2029 | 2020-05-15 |
| Integra Lifesciences Corporation | 510(k) number | 2019-03-08 | Class II | 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 | 2029 | 2020-05-15 |
| Integra Lifesciences Corporation | 510(k) number | 2019-03-08 | Class II | 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 | 2029 | 2020-05-15 |
| Integra Lifesciences Corporation | 510(k) number | 2019-03-08 | Class II | 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 | 2029 | 2020-05-15 |
| Integra Lifesciences Corporation | 510(k) number | 2019-03-08 | Class II | 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 | 2029 | 2020-05-15 |
| Integra Lifesciences Corporation | 510(k) number | 2019-03-08 | Class II | 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 | 2029 | 2020-05-15 |
| Integra Lifesciences Corporation | 510(k) number | 2019-03-08 | Class II | 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 | 2029 | 2020-05-15 |
| Integra Lifesciences Corporation | 510(k) number | 2019-03-08 | Class II | 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 | 2029 | 2020-05-15 |
| Integra Lifesciences Corporation | 510(k) number | 2019-03-08 | Class II | 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 | 2029 | 2020-05-15 |
| Integra Lifesciences Corporation | 510(k) number | 2019-03-08 | Class II | 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 | 2029 | 2020-05-15 |
| Integra Lifesciences Corporation | 510(k) number | 2019-03-08 | Class II | 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 | 2029 | 2020-05-15 |
| Integra Lifesciences Corporation | 510(k) number | 2019-03-08 | Class II | 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 | 2029 | 2020-05-15 |
| Integra Lifesciences Corporation | 510(k) number | 2019-03-08 | Class II | 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 | 2029 | 2020-05-15 |
| Integra Lifesciences Corporation | 510(k) number | 2019-03-08 | Class II | 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 | 2029 | 2020-05-15 |
| Integra Lifesciences Corporation | 510(k) number | 2019-03-08 | Class II | 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 | 2029 | 2020-05-15 |
| Integra Lifesciences Corporation | 510(k) number | 2019-03-08 | Class II | 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 | 2029 | 2020-05-15 |
| Tornier Inc. | 510(k) number | 2015-08-06 | Class II | Nonconforming Material/Component | 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 Salto Talaris Talar Pin Setting guide. Th | 5 | 2016-04-08 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.