Vanguard Knee System
49 catalogue numbers from EP-183646, listed by Biomet Orthopedics, United States, under Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
49catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Jiangsu (2), Zhejiang (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
Record
| Listed by | Biomet Orthopedics, United States |
|---|---|
| FDA product code | MBV |
| Device type | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3560 |
| 510(k) | K080528 |
| Record published | 2015-10-24 |
| Record revised | 2025-05-30 (version 9) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EP-183646 | 16 MM 71/75 MM | In distribution |
| EP-183561 | 11 MM 79/83 MM | In distribution |
| EP-189143 | 13 MM 87 MM | In distribution |
| EP-183406 | 16 MM 59 MM | In distribution |
| EP-183464 | 14 MM 79/83 MM | In distribution |
| 189320 | 10 MM 83 MM | In distribution |
| CP113583 | 16 MM 87 MM | In distribution |
| EP-183728 | 18 MM 63/67 MM | In distribution |
| EP-183744 | 14 MM 71/75 MM | In distribution |
| EP-189048 | 18 MM 67 MM | In distribution |
| CP113592 | 18 mm 91 mm | In distribution |
| EP-183724 | 14 MM 63/67 MM | In distribution |
| EP-183540 | 10 MM 71/75 MM | In distribution |
| CP113635 | 60 MM | In distribution |
| 189720 | 10 MM 83 MM | In distribution |
| CP113619 | 65 MM | In distribution |
| 189142 | 12 MM 87 MM | In distribution |
| EP-189044 | 14 MM 67 MM | In distribution |
| EP-183426 | 16 MM 63/67 MM | In distribution |
| EP-183688 | 18 MM 87/91 MM | In distribution |
| EP-184770 | 40 MM 10 MM | In distribution |
| 189246 | 16 MM 67 MM | In distribution |
| 189704 | 14 MM 79 MM | In distribution |
| EP-189002 | 12 MM 59 MM | In distribution |
| EP-183568 | 18 MM 79/83 MM | In distribution |
| 184786 | 34 mm 7.8 mm | In distribution |
| EP-183541 | 11 MM 71/75 MM | In distribution |
| 189726 | 16 MM 83 MM | In distribution |
| EP-183603 | 13 MM 59 MM | In distribution |
| EP-183580 | 10 MM 87/91 MM | In distribution |
| EP-189140 | 10 MM 87 MM | In distribution |
| EP-184792 | 31 MM 8 MM | In distribution |
| EP-183466 | 16 MM 79/83 MM | In distribution |
| EP-184791 | 28 MM 8 MM | In distribution |
| EP-189041 | 11 MM 67 MM | In distribution |
| 189108 | 18 MM 79 MM | In distribution |
| EP-183480 | 10 MM 87/91 MM | In distribution |
| EP-184762 | 28 MM 8 MM | In distribution |
| 189622 | 12 MM 63 MM | In distribution |
| EP-183468 | 18 MM 79/83 MM | In distribution |
| 184782 | 28 mm 6.2 mm | In distribution |
| EP-183408 | 18 MM 59 MM | In distribution |
| 184762 | 28 mm 8 mm | In distribution |
| 189644 | 14 MM 67 MM | In distribution |
| EP-183642 | 12 MM 71/75 MM | In distribution |
| EP-189008 | 18 MM 59 MM | In distribution |
| EP-183608 | 18 MM 59 MM | In distribution |
| EP-183500 | 10 MM 59 MM | In distribution |
| EP-183788 | 18 MM 87/91 MM | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Vanguard XP® Instrumentation | Biomet Orthopedics | 130 |
| Vanguard Complete Knee System | Biomet Orthopedics | 106 |
| Vanguard® 360 Instrument | Biomet Orthopedics | 98 |
| Biomet® Knee System | Biomet Orthopedics | 94 |
| Maxim Knee System | Biomet Orthopedics | 73 |
| Vanguard Instrument | Biomet Orthopedics | 44 |
| Vanguard 360 Revision System | Biomet Orthopedics | 43 |
| Biomet® 360 | Biomet Orthopedics | 39 |
| Biomet® 360 Instrument | Biomet Orthopedics | 36 |
| Vanguard 360 | Biomet Orthopedics | 30 |
| Biomet 360 Knee System | Biomet Orthopedics | 27 |
| Vanguard® SSK 360 Knee System | Biomet Orthopedics | 19 |
Showing 12 of 41. All products under Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer
Recalls Naming This Product
25 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 |
|---|---|---|---|---|---|---|---|
| Biomet, Inc. | 510(k) number | 2024-03-13 | Class II | Process change control | Possible damage to the Vanguard Knee System AS Tibial Bearing caused during the manufacturing process. | 19 units (1 US, 18 OUS) | |
| Biomet, Inc. | 510(k) number | 2022-12-29 | Class II | Labeling Change Control | Components Incorrectly labeled as either smaller or larger and incorrect side (right/left). | 157 units | |
| Biomet, Inc. | 510(k) number | 2022-12-29 | Class II | Labeling Change Control | Components Incorrectly labeled as either smaller or larger and incorrect side (right/left). | 91 units | |
| Biomet, Inc. | 510(k) number | 2020-04-17 | Class II | Process control | Potential presence of elevated endotoxin levels that exceed the specification limit | 11 units | 2021-06-25 |
| Biomet, Inc. | 510(k) number | 2020-04-17 | Class II | Process control | Potential presence of elevated endotoxin levels that exceed the specification limit | 107 units | 2021-06-25 |
| Biomet, Inc. | 510(k) number | 2020-04-17 | Class II | Process control | Potential presence of elevated endotoxin levels that exceed the specification limit | 91 units | 2021-06-25 |
| Biomet, Inc. | 510(k) number | 2018-12-21 | Class II | Under Investigation by firm | Vanguard Knee System Series-A Standard Patella a potential commingle that could result in the size of the implant not matching the size on the label. | 45 units | 2020-05-13 |
| Biomet, Inc. | 510(k) number | 2018-12-21 | Class II | Under Investigation by firm | Vanguard Knee System Series-A Standard Patella a potential commingle that could result in the size of the implant not matching the size on the label. | 90 units | 2020-05-13 |
| Biomet, Inc. | 510(k) number | 2018-10-22 | Class II | Labeling mix-ups | Label on the outer carton or the patient labels does not match label on the inner sterile packaging | 8 units | 2019-12-11 |
| Biomet, Inc. | 510(k) number | 2018-10-22 | Class II | Labeling mix-ups | Label on the outer carton or the patient labels does not match label on the inner sterile packaging | 8 units | 2019-12-11 |
| Biomet, Inc. | 510(k) number | 2018-05-24 | Class II | Under Investigation by firm | Two lots of tibial bearings were commingled. There is a possibility that a 14mm tibial bearing is packaged in a box labeled as 12 mm tibial bearing and vice versa. This may lead to extension of surgery to find another implant. | 48 | 2020-04-07 |
| Biomet, Inc. | 510(k) number | 2018-05-18 | Class II | Under Investigation by firm | One lot of 75mm tibial tray is potentially etched and labeled as a 79 mm tibial tray. This may lead to delay in surgery, or immediate revision surgery to remove an incorrectly sized tibial component after it has been cemented. | 16 | 2020-03-31 |
| Biomet, Inc. | 510(k) number | 2018-05-11 | Class II | Under Investigation by firm | The label master file was errantly set up as a 63/37mm instead of a 63/67mm. There is no 63/37 size offered, and the product is laser marked with the correct size. | 169 | 2019-11-21 |
| Biomet, Inc. | 510(k) number | 2017-10-03 | Class II | Error in labeling | The affected products are labeled as a 62.5mm LEFT Femur; however, the contents are a Vanguard 70mm RIGHT Femur. | 8 | 2018-08-23 |
| Biomet, Inc. | 510(k) number | 2017-02-17 | Class II | Process design | Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components. | 28,253 in total | 2018-01-29 |
| Biomet, Inc. | 510(k) number | 2011-10-04 | Not classified | Error in labeling | Correcting language on product labeling which incorrectly states patella buttons are intended for use with the AGC knee system. | 2013-04-08 | |
| Biomet, Inc. | 510(k) number | 2011-10-04 | Not classified | Error in labeling | Correcting language on product labeling which incorrectly states patella buttons are intended for use with the AGC knee system. | 2013-04-08 | |
| Biomet, Inc. | 510(k) number | 2011-10-04 | Not classified | Error in labeling | Correcting language on product labeling which incorrectly states patella buttons are intended for use with the AGC knee system. | 2013-04-08 | |
| Biomet, Inc. | 510(k) number | 2011-10-04 | Not classified | Error in labeling | Correcting language on product labeling which incorrectly states patella buttons are intended for use with the AGC knee system. | 2013-04-08 | |
| Biomet, Inc. | 510(k) number | 2011-10-04 | Not classified | Error in labeling | Correcting language on product labeling which incorrectly states patella buttons are intended for use with the AGC knee system. | 2013-04-08 | |
| Biomet, Inc. | 510(k) number | 2011-10-04 | Not classified | Error in labeling | Correcting language on product labeling which incorrectly states patella buttons are intended for use with the AGC knee system. | 149 | 2013-04-08 |
| Biomet, Inc. | 510(k) number | 2011-10-04 | Not classified | Error in labeling | Correcting language on product labeling which incorrectly states patella buttons are intended for use with the AGC knee system. | 2013-04-08 | |
| Biomet, Inc. | 510(k) number | 2011-10-04 | Not classified | Error in labeling | Correcting language on product labeling which incorrectly states patella buttons are intended for use with the AGC knee system. | 2013-04-08 | |
| Biomet, Inc. | 510(k) number | 2011-10-04 | Not classified | Error in labeling | Correcting language on product labeling which incorrectly states patella buttons are intended for use with the AGC knee system. | 2013-04-08 | |
| Biomet, Inc. | 510(k) number | 2011-10-04 | Not classified | Error in labeling | Correcting language on product labeling which incorrectly states patella buttons are intended for use with the AGC knee system. | 2013-04-08 |
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.