Vantage®, Activit-E
Tibial Liner Inserter Handle
1manufacturer
101catalogue numbers in this listing
4510(k) clearances naming this product code
5recalls on this 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 | Exactech, 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 | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K232002 |
| Record published | 2024-01-23 |
| Record revised | 2024-09-11 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 350-23-82 | Left | In distribution |
| 350-23-45 | Size 5 | In distribution |
| 350-23-83 | 16mm | In distribution |
| 350-24-44 | Right | In distribution |
| 350-23-65 | Left | In distribution |
| 350-24-53 | Right | In distribution |
| 350-24-51 | 11mm | In distribution |
| 350-24-02 | 6mm | In distribution |
| 350-24-85 | Size 5 | In distribution |
| 350-23-35 | Left | In distribution |
| 350-24-21 | Size 1 | In distribution |
| 350-24-32 | Size 2 | In distribution |
| 350-23-81 | Left | In distribution |
| 350-23-53 | 11mm | In distribution |
| 350-23-31 | Size 1 | In distribution |
| 350-24-95 | 18mm | In distribution |
| 350-24-72 | 14mm | In distribution |
| 350-23-64 | 12mm | In distribution |
| 350-23-54 | Left | In distribution |
| 350-23-01 | Left | In distribution |
| 350-23-05 | 6mm | In distribution |
| 350-24-34 | Size 4 | In distribution |
| 350-23-52 | Left | In distribution |
| 350-24-15 | Size 5 | In distribution |
| 350-23-74 | Size 4 | In distribution |
| 350-24-04 | Size 4 | In distribution |
| 350-24-94 | Size 4 | In distribution |
| 350-24-52 | Size 2 | In distribution |
| 350-24-13 | 7mm | In distribution |
| 350-24-91 | Right | In distribution |
| 350-23-95 | Size 5 | In distribution |
| 350-23-25 | Left | In distribution |
| 350-23-44 | Left | In distribution |
| 350-24-25 | 8mm | In distribution |
| 350-23-94 | Size 4 | In distribution |
| 350-24-92 | 18mm | In distribution |
| 350-23-02 | Size 2 | In distribution |
| 350-24-75 | Size 5 | In distribution |
| 350-24-05 | Right | In distribution |
| 350-24-11 | 7mm | In distribution |
| 350-23-24 | Size 4 | In distribution |
| 350-23-23 | Left | In distribution |
| 350-24-12 | 7mm | In distribution |
| 350-24-55 | Size 5 | In distribution |
| 350-23-21 | 8mm | In distribution |
| 350-23-91 | Size 1 | In distribution |
| 350-23-71 | 14mm | In distribution |
| 350-23-13 | Left | In distribution |
| 350-23-61 | Left | In distribution |
| 350-24-24 | 8mm | In distribution |
| 350-23-34 | Left | In distribution |
| 350-23-04 | Left | In distribution |
| 350-24-73 | Right | In distribution |
| 350-23-72 | 14mm | In distribution |
| 350-23-43 | Left | In distribution |
| 350-23-63 | 12mm | In distribution |
| 350-23-03 | Size 3 | In distribution |
| 350-24-64 | Right | In distribution |
| 350-23-85 | Left | In distribution |
| 350-24-63 | Size 3 | In distribution |
| 350-24-35 | Size 5 | In distribution |
| 350-23-93 | 18mm | In distribution |
| 350-23-11 | Size 1 | In distribution |
| 350-23-75 | Left | In distribution |
| 350-24-84 | Right | In distribution |
| 350-24-61 | Size 1 | In distribution |
| 350-24-83 | 16mm | In distribution |
| 350-23-22 | Left | In distribution |
| 350-24-74 | Size 4 | In distribution |
| 350-24-65 | 12mm | In distribution |
| 350-23-14 | 7mm | In distribution |
| 350-24-93 | Right | In distribution |
| 350-24-62 | 12mm | In distribution |
| 350-24-31 | 9mm | In distribution |
| 350-24-82 | Size 2 | In distribution |
| 350-24-41 | Right | In distribution |
| 350-23-92 | 18mm | In distribution |
| 350-23-51 | Left | In distribution |
| 350-24-33 | Size 3 | In distribution |
| 350-24-03 | 6mm | In distribution |
| 350-23-12 | 7mm | In distribution |
| 350-24-71 | Size 1 | In distribution |
| 350-23-42 | Left | In distribution |
| 350-24-45 | Size 5 | In distribution |
| 350-24-14 | 7mm | In distribution |
| 350-23-73 | Size 3 | In distribution |
| 350-24-43 | Size 3 | In distribution |
| 350-24-42 | Size 2 | In distribution |
| 350-24-54 | Size 4 | In distribution |
| 350-24-22 | Right | In distribution |
| 350-24-01 | Size 1 | In distribution |
| 350-23-55 | 11mm | In distribution |
| 350-23-33 | Left | In distribution |
| 350-24-81 | Size 1 | In distribution |
| 350-23-32 | 9mm | In distribution |
| 03-CNB-LN-0000 | In distribution | |
| 350-23-15 | 7mm | In distribution |
| 350-23-84 | 16mm | In distribution |
| 350-23-41 | 10mm | In distribution |
| 350-24-23 | Size 3 | In distribution |
| 350-23-62 | 12mm | 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 |
|---|---|
| K230717 | 2023-10-12 |
| K232002 | 2023-09-11 |
| K183343 | 2019-04-01 |
| K152217 | 2016-03-10 |
Recalls
5 of these are 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 |
|---|---|---|---|---|---|
| 2023-11-21 | Class II | Packaging change control | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. | ||
| 2021-08-30 | Class II | Process control | Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. | 2,217 devices | |
| 2020-08-10 | Class II | Error in labeling | The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm, were found to have a labeling error. Exactech is recalling the Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm because they were found to have a | 11 units | |
| 2017-05-16 | Class II | Under Investigation by firm | Possible inner labeling and packaged device not matching the outer label on the box. | 9 | 2021-04-22 |
| 2017-05-16 | Class II | Under Investigation by firm | Possible inner labeling and packaged device not matching the outer label on the box. | 9 | 2021-04-22 |
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.