Salto Talaris
112 catalogue numbers from LJU424, listed by Tornier Inc., United States, under Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer. 1 manufacturer in China is registered for this product code.
1manufacturer
112catalogue numbers in this listing
2510(k) clearances naming this product code
1recall
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 |
|---|---|---|
| LJU424 | Thickness 17 mm | Withdrawn |
| LJV307 | Thickness 19 mm | Withdrawn |
| LJU246 | Size 1 | Withdrawn |
| LJU215 | Thickness 8 mm | Withdrawn |
| LJU231 | Size 0 | Withdrawn |
| LJV301 | Thickness 9 mm | Withdrawn |
| LJU258 | Thickness 11 mm | Withdrawn |
| LJU223 | Size 3 | Withdrawn |
| LJU237 | Size 1 | Withdrawn |
| LJU243 | Thickness 21 mm | Withdrawn |
| LJV306 | Thickness 17 mm | Withdrawn |
| LJU235 | Size 1 | Withdrawn |
| LJU267 | Thickness 10 mm | Withdrawn |
| LJU249 | Size 1 | Withdrawn |
| LJU241 | Thickness 17 mm | Withdrawn |
| LJU225 | Thickness 8 mm | Withdrawn |
| LJU426 | Thickness 21 mm | Withdrawn |
| LJU412 | Thickness 13 mm | Withdrawn |
| LJU287 | Size 3 | Withdrawn |
| LJU202 | Size 2 | Withdrawn |
| LJU288 | Size 3 | Withdrawn |
| LJU238 | Size 1 | Withdrawn |
| LJV316 | Size 01 | Withdrawn |
| LJU293 | Thickness 21 mm | Withdrawn |
| LJU282 | Thickness 19 mm | Withdrawn |
| LJU227 | Thickness 10 mm | Withdrawn |
| LJV220 | Size 0 | Withdrawn |
| LJU275 | Thickness 8 mm | Withdrawn |
| LJU410 | Thickness 10 mm | Withdrawn |
| LJU423 | Thickness 15 mm | Withdrawn |
| LJV222 | Size 0 | Withdrawn |
| LJU242 | Thickness 19 mm | Withdrawn |
| LJV317 | Thickness 19 mm | Withdrawn |
| LJU263 | Thickness 21 mm | Withdrawn |
| LJU262 | Size 2 | Withdrawn |
| LJU218 | Thickness 11 mm | Withdrawn |
| LJU419 | Thickness 9 mm | Withdrawn |
| LJU247 | Size 1 | Withdrawn |
| LJU250 | Thickness 15 mm | Withdrawn |
| LJV223 | Size 0 | Withdrawn |
| LJU268 | Thickness 11 mm | Withdrawn |
| LJV305 | Size 01 | Withdrawn |
| LJU281 | Thickness 17 mm | Withdrawn |
| LJU257 | Size 2 | Withdrawn |
| LJU260 | Size 2 | Withdrawn |
| LJV313 | Size 01 | Withdrawn |
| LJU411 | Thickness 11 mm | Withdrawn |
| LJU256 | Thickness 9 mm | Withdrawn |
| LJU233 | Thickness 21 mm | Withdrawn |
| LJV303 | Size 01 | Withdrawn |
| LJU253 | Size 1 | Withdrawn |
| LJV221 | Thickness 17 mm | Withdrawn |
| LJU251 | Size 1 | Withdrawn |
| LJU248 | Thickness 11 mm | Withdrawn |
| LJV318 | Thickness 21 mm | Withdrawn |
| LJU283 | Size 3 | Withdrawn |
| LJU226 | Size 0 | Withdrawn |
| LJU265 | Thickness 8 mm | Withdrawn |
| LJU245 | Thickness 8 mm | Withdrawn |
| LJU228 | Size 0 | Withdrawn |
| LJV310 | Thickness 8 mm | Withdrawn |
| LJU270 | Size 2 | Withdrawn |
| LJU278 | Thickness 11 mm | Withdrawn |
| LJV308 | Thickness 21 mm | Withdrawn |
| LJV304 | Size 01 | Withdrawn |
| LJU408 | Thickness 8 mm | Withdrawn |
| LJU240 | Size 1 | Withdrawn |
| LJU236 | Thickness 9 mm | Withdrawn |
| LJU266 | Thickness 9 mm | Withdrawn |
| LJU269 | Size 2 | Withdrawn |
| LJU239 | Size 1 | Withdrawn |
| LJV300 | Thickness 8 mm | Withdrawn |
| LJU217 | Thickness 10 mm | Withdrawn |
| LJU272 | Thickness 19 mm | Withdrawn |
| LJU420 | Size 00 | Withdrawn |
| LJU230 | Thickness 15 mm | Withdrawn |
| LJU286 | Thickness 9 mm | Withdrawn |
| LJU414 | Thickness 17 mm | Withdrawn |
| LJU421 | Thickness 11 mm | Withdrawn |
| LJU413 | Size 00 | Withdrawn |
| LJU280 | Thickness 15 mm | Withdrawn |
| LJU255 | Size 2 | Withdrawn |
| LJU229 | Size 0 | Withdrawn |
| LJV315 | Thickness 15 mm | Withdrawn |
| LJV314 | Thickness 13 mm | Withdrawn |
| LJU216 | Thickness 9 mm | Withdrawn |
| LJU232 | Size 0 | Withdrawn |
| LJU285 | Thickness 8 mm | Withdrawn |
| LJU277 | Thickness 10 mm | Withdrawn |
| LJU220 | Size 0 | Withdrawn |
| LJV302 | Thickness 10 mm | Withdrawn |
| LJU261 | Size 2 | Withdrawn |
| LJU416 | Size 00 | Withdrawn |
| LJU273 | Size 2 | Withdrawn |
| LJV219 | Thickness 13 mm | Withdrawn |
| LJV312 | Size 01 | Withdrawn |
| LJU415 | Thickness 19 mm | Withdrawn |
| LJU259 | Thickness 13 mm | Withdrawn |
| LJU279 | Thickness 13 mm | Withdrawn |
| LJU425 | Thickness 19 mm | Withdrawn |
| LJU289 | Thickness 13 mm | Withdrawn |
| LJU422 | Size 00 | Withdrawn |
| LJU291 | Size 3 | Withdrawn |
| LJV311 | Size 01 | Withdrawn |
| LJU418 | Size 00 | Withdrawn |
| LJU252 | Size 1 | Withdrawn |
| LJU200 | Size 0 | Withdrawn |
| LJU271 | Size 2 | Withdrawn |
| LJU276 | Thickness 9 mm | Withdrawn |
| LJU292 | Thickness 19 mm | Withdrawn |
| LJU290 | Thickness 15 mm | Withdrawn |
| LJU409 | Size 00 | 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.