Evolve
75 catalogue numbers from 496H218, listed by Wright Medical Technology, Inc., United States, under Prosthesis, Elbow, Hemi-, Radial, Polymer. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
75catalogue numbers in this listing
5recalls on this code
Who Else Makes It
Concentrated in Shanghai (2), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Wright Medical Technology, Inc., United States |
|---|---|
| FDA product code | KWI |
| Device type | Prosthesis, Elbow, Hemi-, Radial, Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3170 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K060731 |
| Record published | 2015-10-01 |
| Record revised | 2022-03-25 (version 4) |
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, manufacturing date |
| Sizes | Outer diameter 4.5 to 28 mm |
| Distribution end date | 2016-07-27 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 496H218 | Outer Diameter 18 mm | In distribution |
| 496S245 | Outer Diameter 4.5 mm | In distribution |
| 496H222 | Size: +2 | In distribution |
| 496H420 | Size: +4 | In distribution |
| 496S085 | Outer Diameter 8.5 mm | In distribution |
| 496H020 | Outer Diameter 20 mm | In distribution |
| 496H428 | Outer Diameter 28 mm | In distribution |
| 496H028 | Outer Diameter 28 mm | In distribution |
| 496S075 | Outer Diameter 7.5 mm | In distribution |
| 496S265 | Size: +2 | In distribution |
| 496S475 | Size: +4 | In distribution |
| 496S275 | Size: +2 | In distribution |
| 496H418 | Size: +4 | In distribution |
| 496S055 | Outer Diameter 5.5 mm | In distribution |
| 496H026 | Outer Diameter 26 mm | In distribution |
| 496H022 | Outer Diameter 22 mm | In distribution |
| 496H224 | Outer Diameter 24 mm | In distribution |
| 496S295 | Size: +2 | In distribution |
| 496S255 | Outer Diameter 5.5 mm | In distribution |
| 496S465 | Outer Diameter 6.5 mm | In distribution |
| 496S445 | Outer Diameter 4.5 mm | In distribution |
| 496S065 | Outer Diameter 6.5 mm | In distribution |
| 496H426 | Size: +4 | In distribution |
| 496S045 | Outer Diameter 4.5 mm | In distribution |
| 496H422 | Size: +4 | In distribution |
| 496H024 | Outer Diameter 24 mm | In distribution |
| 496H226 | Outer Diameter 26 mm | In distribution |
| 496H220 | Outer Diameter 20 mm | In distribution |
| 496H228 | Size: +2 | In distribution |
| 496S495 | Outer Diameter 9.5 mm | In distribution |
| 496H018 | Outer Diameter 18 mm | In distribution |
| 496S485 | Size: +4 | In distribution |
| 496S455 | Size: +4 | In distribution |
| 496H424 | Size: +4 | In distribution |
| 496S095 | Outer Diameter 9.5 mm | In distribution |
| 496S285 | Outer Diameter 8.5 mm | In distribution |
| 496S285 | Size: 2+ | Withdrawn |
| 497H222 | Size: 2+ | Withdrawn |
| 496H218 | Size: 2+ | Withdrawn |
| 497H020 | Outer Diameter 20 mm | Withdrawn |
| 496H422 | Outer Diameter 22 mm | Withdrawn |
| 496S455 | Outer Diameter 5.5 mm | Withdrawn |
| 496S465 | Size: 4+ | Withdrawn |
| 496S265 | Outer Diameter 6.5 mm | Withdrawn |
| 497H226 | Size: 2+ | Withdrawn |
| 497H420 | Outer Diameter 20 mm | Withdrawn |
| 496H228 | Outer Diameter 28 mm | Withdrawn |
| 496S245 | Size: 2+ | Withdrawn |
| 496H220 | Size: 2+ | Withdrawn |
| 496S295 | Outer Diameter 9.5 mm | Withdrawn |
| 496H424 | Outer Diameter 24 mm | Withdrawn |
| 497H220 | Outer Diameter 20 mm | Withdrawn |
| 497H022 | Outer Diameter 22 mm | Withdrawn |
| 496S445 | Size: 4+ | Withdrawn |
| 496H426 | Outer Diameter 26 mm | Withdrawn |
| 496H222 | Outer Diameter 22 mm | Withdrawn |
| 497H026 | Outer Diameter 26 mm | Withdrawn |
| 496S255 | Size: 2+ | Withdrawn |
| 496S495 | Size: 4+ | Withdrawn |
| 496S475 | Outer Diameter 7.5 mm | Withdrawn |
| 497H024 | Size: Standard | Withdrawn |
| 496S275 | Outer Diameter 7.5 mm | Withdrawn |
| 497H228 | Size: 2+ | Withdrawn |
| 496H428 | Size: 4+ | Withdrawn |
| 496H226 | Size: 2+ | Withdrawn |
| 497H224 | Size: 2+ | Withdrawn |
| 496S485 | Outer Diameter 8.5 mm | Withdrawn |
| 496H224 | Size: 2+ | Withdrawn |
| 497H422 | Size: 4+ | Withdrawn |
| 496H418 | Outer Diameter 18 mm | Withdrawn |
| 497H028 | Size: Standard | Withdrawn |
| 497H428 | Size: 4+ | Withdrawn |
| 497H424 | Size: 4+ | Withdrawn |
| 497H426 | Size: 4+ | Withdrawn |
| 496H420 | Outer Diameter 20 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Acumed | Acumed LLC | 175 |
| Align | Skeletal Dynamics L.L.C. | 97 |
| Prosthesis, Elbow, Hemi-, Radial, Polymer | Synthes (U.S.A.) LP | 78 |
| Rhead | Stryker GmbH | 53 |
| L2L™ | Zimmer, Inc. | 48 |
| Prosthesis, Elbow, Hemi-, Radial, Polymer | Synthes Gmbh | 43 |
| Explor | Biomet Orthopedics | 32 |
| Avenger | IN2BONES USA, LLC | 32 |
| BioPoly® Radial Head Implant | Biopoly, LLC | 30 |
| Seitz Solution Radial Head | Kapp Surgical Instrument, Inc. | 27 |
| Integra® | Ascension Orthopedics, Inc. | 23 |
| Modular Radial Head (MRH) System | Smith & Nephew, Inc. | 22 |
Showing 12 of 28. All products under Prosthesis, Elbow, Hemi-, Radial, Polymer
Recalls Naming This Product
5 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 |
|---|---|---|---|---|---|---|---|
| Wright Medical Technology, Inc. | 510(k) number | 2022-08-03 | Class II | Under Investigation by firm | The outer label does not match the device inside the package. The affected lot of EVOLVE Proline Stem 7.5mm +2 contains a size 9.5mm +4 stem, while the affected lot of EVOLVE Proline Stem 9.5mm +4 contains a size 7.5mm +2 stem. | 16 units | |
| Wright Medical Technology, Inc. | 510(k) number | 2022-08-03 | Class II | Under Investigation by firm | The outer label does not match the device inside the package. The affected lot of EVOLVE Proline Stem 7.5mm +2 contains a size 9.5mm +4 stem, while the affected lot of EVOLVE Proline Stem 9.5mm +4 contains a size 7.5mm +2 stem. | 32 units | |
| Wright Medical Technology, Inc. | 510(k) number | 2020-08-26 | Class II | Process control | Lack of sterility assurance | 16 stems | 2021-04-27 |
| Wright Medical Technology, Inc. | 510(k) number | 2019-12-27 | Class II | Process control | Two lots of EVOLVE Modular Radial Head could have the wrong size product in the package. Both the label and laser marking are incorrect on the affected product. | 39 devices | 2021-07-23 |
| Wright Medical Technology, Inc. | 510(k) number | 2019-12-27 | Class II | Process control | Two lots of EVOLVE Modular Radial Head could have the wrong size product in the package. Both the label and laser marking are incorrect on the affected product. | 48 devices | 2021-07-23 |
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.