Vivacit-E®
Vivacit-E unicompartmental knee components provide a highly cross-linked, vitamin-E-containing polyethylene bearing within the Zimmer Unicompartmental Knee System. The system replaces one…
Vivacit-E unicompartmental knee components provide a highly cross-linked, vitamin-E-containing polyethylene bearing within the Zimmer Unicompartmental Knee System. The system replaces one compartment of the knee rather than all knee surfaces.
The femoral and tibial articulation allows anteroposterior, mediolateral and rotational movement without mechanical constraint in those directions. Surrounding ligaments and soft tissues limit that movement.
Bearing and Fixation
The polyethylene component works with the compatible femoral and tibial parts of the unicompartmental reconstruction. The described knee system is intended for cemented use. Vivacit-E identifies the polyethylene material configuration used for its bearing components.
Who Else Makes It
Concentrated in Zhejiang (2), Jiangsu (2), Shanghai (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
Record
| Listed by | Zimmer, Inc., United States |
|---|---|
| FDA product code | HSX |
| Device type | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3520 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K122529 |
| Record published | 2017-09-27 |
| Record revised | 2018-07-06 (version 3) |
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 |
| Sizes | Height 8 to 14 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00-5842-095-08 | Size 5 | In distribution |
| 00-5842-092-09 | Height 9 mm | In distribution |
| 00-5842-091-10 | Size 1 | In distribution |
| 00-5842-096-08 | Size 6 | In distribution |
| 00-5842-094-12 | Height 12 mm | In distribution |
| 00-5842-096-10 | Height 10 mm | In distribution |
| 00-5842-092-10 | Height 10 mm | In distribution |
| 00-5842-095-11 | Height 11.00 mm | In distribution |
| 00-5842-092-11 | Height 11.00 mm | In distribution |
| 00-5842-092-12 | Size 2 | In distribution |
| 00-5842-093-12 | Height 12.00 mm | In distribution |
| 00-5842-092-14 | Size 2 | In distribution |
| 00-5842-092-12 | Size 2 | In distribution |
| 00-5842-091-11 | Height 11 mm | In distribution |
| 00-5842-096-14 | Size 6 | In distribution |
| 00-5842-093-12 | Size 3 | In distribution |
| 00-5842-094-10 | Size 4 | In distribution |
| 00-5842-093-11 | Height 11.00 mm | In distribution |
| 00-5842-094-08 | Size 4 | In distribution |
| 00-5842-093-10 | Height 10.00 mm | In distribution |
| 00-5842-091-12 | Size 1 | In distribution |
| 00-5842-094-14 | Size 4 | In distribution |
| 00-5842-091-10 | Size 1 | In distribution |
| 00-5842-095-14 | Height 14.00 mm | In distribution |
| 00-5842-095-08 | Height 8.00 mm | In distribution |
| 00-5842-093-08 | Size 3 | In distribution |
| 00-5842-093-08 | Height 8 mm | In distribution |
| 00-5842-092-08 | Height 8 mm | In distribution |
| 00-5842-096-14 | Height 14.00 mm | In distribution |
| 00-5842-094-10 | Size 4 | In distribution |
| 00-5842-096-11 | Height 11 mm | In distribution |
| 00-5842-096-12 | Height 12.00 mm | In distribution |
| 00-5842-096-09 | Size 6 | In distribution |
| 00-5842-094-12 | Height 12.00 mm | In distribution |
| 00-5842-093-10 | Height 10 mm | In distribution |
| 00-5842-094-08 | Height 8.00 mm | In distribution |
| 00-5842-096-10 | Size 6 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Journey | Smith & Nephew, Inc. | 517 |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | Ortho Development Corp. | 303 |
| BKS® Uni | Ortho Development Corp. | 240 |
| LinkSymphoKnee | Waldemar Link GmbH & Co. KG | 210 |
| Moto Partial Knee System | Medacta International SA | 205 |
| Arthrex® | Arthrex, Inc. | 199 |
| Stride | Smith & Nephew, Inc. | 190 |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | Zimmer, Inc. | 175 |
| ZUK | Smith & Nephew, Inc. | 161 |
| Tahoe Uni Knee System | Shalby Advanced Technologies, Inc. | 134 |
| Moto Partial Knee System – Medial | Medacta International SA | 132 |
| Journey II | Smith & Nephew, Inc. | 119 |
Showing 12 of 171. All products under Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K200151 | 2020-03-17 |
| K122529 | 2012-11-16 |
| K033363 | 2004-01-16 |
| K010685 | 2001-04-02 |
| K952068 | 1995-09-19 |
| K942263 | 1995-07-11 |
| K880155 | 1988-08-03 |
| K862632 | 1987-03-25 |
| K803235 | 1981-02-04 |
Recalls
4 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 |
|---|---|---|---|---|---|
| 2017-11-29 | Class II | Packaging | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag. | 13,227 in total | 2020-04-02 |
| 2017-11-29 | Class II | Packaging | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag. | 13,227 in total | 2020-04-02 |
| 2016-01-11 | Class II | Process control | LDPE bag containing the implant adheres to the highly polished implant surface. | 32537 | 2017-05-23 |
| 2013-08-30 | Class II | Package design/selection | The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices. | 32537 | 2014-09-25 |
| 2009-02-26 | Not classified | Process control | Smaller diameter screws than required were included in the package. | 13 | 2011-02-28 |
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.