Vanguard® Vivacit-E®
The FDA filing describes a modification to the tibial bearings within the Vanguard Complete Knee System. Its performance section specifically identifies Vivacit-E tibial bearings, tying the…
The FDA filing describes a modification to the tibial bearings within the Vanguard Complete Knee System.
Its performance section specifically identifies Vivacit-E tibial bearings, tying the listed Vivacit-E name to the bearing component rather than to the full knee system.
System Context
The submission states that the modification does not change the other Vanguard Complete Knee System components. The filing also evaluates manufacturing-slot stress in the Vivacit-E bearings.
21manufacturers in China registered for this device type
62catalogue numbers in this listing
51510(k) clearances naming this product code
40recalls on this code
Who Else Makes It
Concentrated in Jiangsu (10), Shanghai (4), Beijing (3). 13 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| 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 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| b-ONE Medical (Beijing) Co., Ltd. | Beijing | Beijing | Contract manufacturer | 7 |
| Changzhou Wastonortho Medical Appliance Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 5 |
Showing 12 of 21. All 21 manufacturers in China registered for Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Record
| Listed by | Zimmer, Inc., United States |
|---|---|
| FDA product code | JWH |
| Device type | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3560 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K183583 |
| Record published | 2019-10-11 |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Width 59 to 91 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| VE183522 | Width 63.00 mm | In distribution |
| VE183700 | 10 mm, Thickness | In distribution |
| VE189000 | Width 59.00 mm | In distribution |
| VE183486 | Width 87.00 mm | In distribution |
| VE183562 | 12 mm, Thickness | In distribution |
| VE189080 | 10 mm, Thickness | In distribution |
| VE189142 | 12 mm, Thickness | In distribution |
| VE183426 | Width 63.00 mm | In distribution |
| VE183500 | 10 mm, Thickness | In distribution |
| VE183702 | Width 59.00 mm | In distribution |
| VE183780 | Width 87.00 mm | In distribution |
| VE189103 | 13 mm, Thickness | In distribution |
| VE183581 | Width 87.00 mm | In distribution |
| VE183666 | 16 mm, Thickness | In distribution |
| VE183506 | 16 mm, Thickness | In distribution |
| VE183626 | Width 67.00 mm | In distribution |
| VE189064 | Width 71.00 mm | In distribution |
| VE183786 | Width 87.00 mm | In distribution |
| VE189123 | 13 mm, Thickness | In distribution |
| VE183540 | Width 71.00 mm | In distribution |
| VE183482 | Width 87.00 mm | In distribution |
| VE183640 | 10 mm, Thickness | In distribution |
| VE183582 | 12 mm, Thickness | In distribution |
| VE183468 | 18 mm, Thickness | In distribution |
| VE183766 | Width 83.00 mm | In distribution |
| VE189066 | 16 mm, Thickness | In distribution |
| VE189124 | 14 mm, Thickness | In distribution |
| VE183560 | 10 mm, Thickness | In distribution |
| VE189003 | Width 59.00 mm | In distribution |
| VE183661 | 11 mm, Thickness | In distribution |
| VE183424 | Width 63.00 mm | In distribution |
| VE183501 | Width 59.00 mm | In distribution |
| VE183643 | Width 75.00 mm | In distribution |
| VE183608 | Width 59.00 mm | In distribution |
| VE183422 | 12 mm, Thickness | In distribution |
| VE183441 | Width 75.00 mm | In distribution |
| VE183641 | Width 75.00 mm | In distribution |
| VE183524 | 14 mm, Thickness | In distribution |
| VE183683 | 13 mm, Thickness | In distribution |
| VE183403 | 13 mm, Thickness | In distribution |
| VE189082 | Width 75.00 mm | In distribution |
| VE183461 | Width 83.00 mm | In distribution |
| VE189108 | 18 mm, Thickness | In distribution |
| VE189068 | 18 mm, Thickness | In distribution |
| VE183602 | 12 mm, Thickness | In distribution |
| VE189026 | Width 63.00 mm | In distribution |
| VE183423 | Width 67.00 mm | In distribution |
| VE183684 | 14 mm, Thickness | In distribution |
| VE183706 | 16 mm, Thickness | In distribution |
| VE183561 | Width 79.00 mm | In distribution |
| VE183502 | Width 59.00 mm | In distribution |
| VE183624 | 14 mm, Thickness | In distribution |
| VE183681 | 11 mm, Thickness | In distribution |
| VE183788 | 18 mm, Thickness | In distribution |
| VE183686 | Width 87.00 mm | In distribution |
| VE189086 | 16 mm, Thickness | In distribution |
| VE183784 | Width 91.00 mm | In distribution |
| VE183503 | Width 59.00 mm | In distribution |
| VE189106 | Width 79.00 mm | In distribution |
| VE183682 | Width 91.00 mm | In distribution |
| VE183688 | Width 91.00 mm | In distribution |
| VE183404 | Width 59.00 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Prophecy® | Microport Orthopedics Inc. | 4,423 |
| Exult Knee Replacement System | Corentec Co., Ltd. | 1,770 |
| Freedom | Maxx Orthopedics Inc. | 1,693 |
| Legion | Smith & Nephew, Inc. | 1,534 |
| MyKnee | Medacta International SA | 1,466 |
| Journey | Smith & Nephew, Inc. | 1,339 |
| Persona® | Zimmer, Inc. | 1,254 |
| DJO Surgical | Encore Medical, L.P. | 1,131 |
| U2 Total Knee System | United Orthopedic Corp. | 1,078 |
| CKS Plus | Shalby Advanced Technologies, Inc. | 1,024 |
| Lospa Modular Knee System | Corentec Co., Ltd. | 1,020 |
| Natural-Knee® | Zimmer, Inc. | 980 |
Showing 12 of 1,175. All products under Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K243724 | 2025-03-06 |
| K230321 | 2023-03-08 |
| K221479 | 2022-11-17 |
| K210829 | 2021-05-18 |
| K210551 | 2021-03-18 |
| K200209 | 2020-03-24 |
| K193223 | 2020-01-24 |
| K191625 | 2019-09-05 |
| K190068 | 2019-06-04 |
| K183583 | 2019-05-10 |
| K181947 | 2018-10-25 |
| K173057 | 2018-03-29 |
| K152494 | 2015-11-25 |
| K142787 | 2014-12-22 |
| K133737 | 2014-02-04 |
| K130143 | 2013-02-22 |
| K122765 | 2012-11-09 |
| K113369 | 2012-03-27 |
| K073286 | 2008-03-07 |
| K072281 | 2007-09-06 |
| K062768 | 2006-10-13 |
| K061882 | 2006-08-01 |
| K060722 | 2006-05-26 |
| K060370 | 2006-04-28 |
| K052879 | 2005-11-22 |
| K050723 | 2005-04-20 |
| K043101 | 2005-03-07 |
| K042271 | 2004-10-13 |
| K023211 | 2002-10-17 |
| K013991 | 2001-12-27 |
| K003910 | 2001-03-19 |
| K991581 | 1999-07-30 |
| K972774 | 1999-05-05 |
| K972270 | 1997-11-24 |
| K963148 | 1997-02-13 |
| K962196 | 1996-08-23 |
| K960279 | 1996-04-26 |
| K951185 | 1996-03-15 |
| K946150 | 1995-07-11 |
| K933785 | 1995-01-30 |
| K930831 | 1993-11-16 |
| K911572 | 1991-07-01 |
| K895639 | 1990-02-08 |
| K892800 | 1989-08-03 |
| K872379 | 1987-10-28 |
| K863805 | 1986-12-02 |
| K853661 | 1985-12-09 |
| K834432 | 1984-04-11 |
| K833363 | 1984-02-13 |
| K830121 | 1983-04-26 |
| K790219 | 1979-05-08 |
Recalls
40 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 |
|---|---|---|---|---|---|
| 2025-02-27 | Class II | Labeling Change Control | The “Use with plate 7, 8, 9, 10” compatibility statement on top of the label does not match with the compatibility statements “USE WITH PLATE 5, 6” in the translations section of the same label. | 76 units | |
| 2025-01-06 | Class II | Process change control | It was identified internally that two commingle events occurred where the metal support post within the polyethylene articular surface was assembled incorrectly for three units within the scope. | 155 units | |
| 2025-01-06 | Class II | Process change control | It was identified internally that two commingle events occurred where the metal support post within the polyethylene articular surface was assembled incorrectly for three units within the scope. | 155 units | |
| 2024-03-28 | Class II | Process change control | Out of specification violation of devices that results in a gap existing within the fixture that presses the fiber metal pad to the substrate, causing the pad to not fully bond to the substrate. | 5,546 units | |
| 2023-05-19 | Class II | Under Investigation by firm | Device outer packaging was incorrectly labeled. | 2026-05-29 | |
| 2022-12-06 | Class II | Under Investigation by firm | Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically significant higher overall revision rates when these tibial components are used wit | 1366 | |
| 2022-12-06 | Class II | Under Investigation by firm | Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically significant higher overall revision rates when these tibial components are used wit | 1049 | |
| 2022-12-06 | Class II | Under Investigation by firm | Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically significant higher overall revision rates when these tibial components are used wit | 1673 | |
| 2022-12-06 | Class II | Under Investigation by firm | Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically significant higher overall revision rates when these tibial components are used wit | 2092 | |
| 2022-12-06 | Class II | Under Investigation by firm | Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically significant higher overall revision rates when these tibial components are used wit | 284 | |
| 2022-12-06 | Class II | Under Investigation by firm | Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically significant higher overall revision rates when these tibial components are used wit | 2460 | |
| 2019-10-10 | Class II | Packaging change control | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 5,459,583 total devices | 2020-05-19 |
| 2019-10-10 | Class II | Packaging change control | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 5,459,583 total devices | 2020-05-19 |
| 2018-10-31 | Class II | Process control | Screw is missing from the package | 19 units | 2019-04-08 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 2017-08-07 | Class II | Under Investigation by firm | There is a potential for intermittent cracks in the raw material batch used to produce the affected products. The cleanliness of the affected products could be compromised if cracks penetrate the surface of the instrument as a result of the | 842 products in total | 2018-08-23 |
| 2017-08-07 | Class II | Under Investigation by firm | There is a potential for intermittent cracks in the raw material batch used to produce the affected products. The cleanliness of the affected products could be compromised if cracks penetrate the surface of the instrument as a result of the | 842 products in total | 2018-08-23 |
| 2017-08-07 | Class II | Under Investigation by firm | There is a potential for intermittent cracks in the raw material batch used to produce the affected products. The cleanliness of the affected products could be compromised if cracks penetrate the surface of the instrument as a result of the | 842 products in total | 2018-08-23 |
| 2017-08-07 | Class II | Under Investigation by firm | There is a potential for intermittent cracks in the raw material batch used to produce the affected products. The cleanliness of the affected products could be compromised if cracks penetrate the surface of the instrument as a result of the | 842 products in total | 2018-08-23 |
| 2017-04-28 | Class II | Under Investigation by firm | Zimmer Biomet is conducting a lot-specific medical device field action for two lots of the NexGen Offset Stem Extension implants. Product complaints indicated that the size etched on the part and labeled on the product packaging were incorr | 24 | 2018-07-03 |
| 2016-01-11 | Class II | Process control | LDPE bag containing the implant adheres to the highly polished implant surface. | 32508 | 2017-05-23 |
| 2016-01-11 | Class II | Process control | LDPE bag containing the implant adheres to the highly polished implant surface. | 88389 | 2017-05-23 |
| 2016-01-11 | Class II | Process control | LDPE bag containing the implant adheres to the highly polished implant surface. | 117359 | 2017-05-23 |
| 2016-01-11 | Class II | Process control | LDPE bag containing the implant adheres to the highly polished implant surface. | 42064 | 2017-05-23 |
| 2016-01-11 | Class II | Process control | LDPE bag containing the implant adheres to the highly polished implant surface. | 61485 | 2017-05-23 |
| 2016-01-11 | Class II | Process control | LDPE bag containing the implant adheres to the highly polished implant surface. | 18093 | 2017-05-23 |
| 2016-01-11 | Class II | Process control | LDPE bag containing the implant adheres to the highly polished implant surface. | 84396 | 2017-05-23 |
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.