Salto XT
16 catalogue numbers from LJV163, listed by Tornier Inc., United States, under Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer. 1 manufacturer in China is registered for this product code.
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 | Tornier 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, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-11-29 |
| Record revised | 2018-09-11 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | expiry date, serial number |
| Distribution end date | 2018-09-11 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LJV163 | Size 3 | Withdrawn |
| LJV162 | Size 2 | Withdrawn |
| LJV182 | Size 2 | Withdrawn |
| LJV171 | Size 1 | Withdrawn |
| LJV190 | Size 0 | Withdrawn |
| LJV173 | Size 3 | Withdrawn |
| LJV180 | Size 0 | Withdrawn |
| LJV160 | Size 0 | Withdrawn |
| LJV161 | Size 1 | Withdrawn |
| LJV181 | Size 1 | Withdrawn |
| LJV193 | Size 3 | Withdrawn |
| LJV191 | Size 1 | Withdrawn |
| LJV183 | Size 3 | Withdrawn |
| LJV170 | Size 0 | Withdrawn |
| LJV192 | Size 2 | Withdrawn |
| LJV172 | Size 2 | Withdrawn |
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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K090076 | 2009-03-17 |
| K060544 | 2006-11-13 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 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.