Integra® XT
Tibial Tray, 35mm Fin, TH10, Size 0
1manufacturer
54catalogue numbers in this listing
2510(k) clearances naming 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 | Ascension Orthopedics, 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 | Manufacturer |
| 510(k) | K153452 |
| Record published | 2017-05-04 |
| Record revised | 2023-01-25 (version 6) |
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 |
| Distribution end date | 2026-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LJV193T | In distribution | |
| LJV304T | In distribution | |
| LJV303T | In distribution | |
| LJV183T | In distribution | |
| LJV163T | In distribution | |
| LJV162T | In distribution | |
| LJV190T | In distribution | |
| LJU415T | In distribution | |
| LJV306T | In distribution | |
| LJU283T | In distribution | |
| LJV181T | In distribution | |
| LJU232T | In distribution | |
| LJU253T | In distribution | |
| LJU242T | In distribution | |
| LJU252T | In distribution | |
| LJU262T | In distribution | |
| LJV191T | In distribution | |
| LJU426T | In distribution | |
| LJV308T | In distribution | |
| LJV300T | In distribution | |
| LJU243T | In distribution | |
| LJU263T | In distribution | |
| LJV316T | In distribution | |
| LJV180T | In distribution | |
| LJV170T | In distribution | |
| LJV311T | In distribution | |
| LJU273T | In distribution | |
| LJU233T | In distribution | |
| LJV160T | In distribution | |
| LJV222T | In distribution | |
| LJU272T | In distribution | |
| LJV305T | In distribution | |
| LJU293T | In distribution | |
| LJV310T | In distribution | |
| LJV182T | In distribution | |
| LJU425T | In distribution | |
| LJV302T | In distribution | |
| LJV318T | In distribution | |
| LJV173T | In distribution | |
| LJV223T | In distribution | |
| LJV313T | In distribution | |
| LJV161T | In distribution | |
| LJU292T | In distribution | |
| LJV192T | In distribution | |
| LJV307T | In distribution | |
| LJV315T | In distribution | |
| LJV172T | In distribution | |
| LJV171T | In distribution | |
| LJV317T | In distribution | |
| LJV301T | In distribution | |
| LJV312T | In distribution | |
| LJV314T | In distribution | |
| LJU416T | In distribution | |
| LJU282T | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K182878 | 2018-12-18 |
| K151459 | 2015-08-31 |
Recalls Naming This Product
8 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 |
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.