Vanguard Complete Knee System
106 catalogue numbers from 195911, 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
106catalogue 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) | K141407 |
| Record published | 2015-10-24 |
| Record revised | 2025-05-30 (version 7) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 195911 | 67.5 MM | In distribution |
| 195544 | 11MM THICKNESS 65/67 TRAY | In distribution |
| 195947 | 67.5 MM | In distribution |
| 195550 | 10MM THICKNESS 69/71 TRAY | In distribution |
| 195837 | 11MM THICKNESS 59 TRAY | In distribution |
| 195629 | 12MM THICKNESS 79MM TRAY | In distribution |
| 195289 | 83 MM | In distribution |
| 195628 | 11MM THICKNESS 79MM TRAY | In distribution |
| 195914 | 75 MM | In distribution |
| 195924 | 70 MM | In distribution |
| 195874 | 13MM THICKNESS 59 TRAY | In distribution |
| 195873 | 12MM THICKNESS 59 TRAY | In distribution |
| 195630 | 13MM THICKNESS 79MM TRAY | In distribution |
| 195283 | 67 MM | In distribution |
| 195855 | 16MM THICKNESS 69/71/73/75 TRAY | In distribution |
| 195562 | 16MM THICKNESS 73/75 TRAY | In distribution |
| 195841 | 16MM THICKNESS 59 TRAY | In distribution |
| 195860 | 13MM THICKNESS 79/83 TRAY | In distribution |
| 195822 | 10MM THICKNESS 79/83 TRAY | In distribution |
| 195849 | 9MM THICKNESS 69/71/73/75 TRAY | In distribution |
| 195933 | 62.5 MM | In distribution |
| 195944 | 60 MM | In distribution |
| 195840 | 14MM THICKNESS 59 TRAY | In distribution |
| 195869 | 16MM THICKNESS 87/91 TRAY | In distribution |
| 195590 | 16MM THICKNESS 91MM TRAY | In distribution |
| 195615 | 12MM THICKNESS 69/71 TRAY | In distribution |
| 195614 | 11MM THICKNESS 69/71 TRAY | In distribution |
| 195633 | 9MM THICKNESS 83MM TRAY | In distribution |
| 195530 | 11MM THICKNESS 59MM TRAY | In distribution |
| 195574 | 13MM THICKNESS 83MM TRAY | In distribution |
| 195577 | 9MM THICKNESS 87MM TRAY | In distribution |
| 195281 | 63 MM | In distribution |
| 195652 | 14MM THICKNESS 91MM TRAY | In distribution |
| 195641 | 10MM THICKNESS 87MM TRAY | In distribution |
| 195640 | 9MM THICKNESS 87MM TRAY | In distribution |
| 195912 | 70 MM | In distribution |
| 195572 | 11MM THICKNESS 83MM TRAY | In distribution |
| 195611 | 16MM THICKNESS 65/67 TRAY | In distribution |
| 195871 | 10MM THICKNESS 59 TRAY | In distribution |
| 195846 | 13MM THICKNESS 63/65/67 TRAY | In distribution |
| 195779 | 9MM THICKNESS 69/71/73/75 TRAY | In distribution |
| 195585 | 10MM THICKNESS 91MM TRAY | In distribution |
| 195560 | 13MM THICKNESS 73/75 TRAY | In distribution |
| 195573 | 12MM THICKNESS 83MM TRAY | In distribution |
| 195632 | 16MM THICKNESS 79MM TRAY | In distribution |
| 195929 | 52.5 MM | In distribution |
| 195541 | 16MM THICKNESS 63MM TRAY | In distribution |
| 195612 | 9MM THICKNESS 69/71 TRAY | In distribution |
| 195602 | 13MM THICKNESS 63MM TRAY | In distribution |
| 195548 | 16MM THICKNESS 65/67 TRAY | In distribution |
| 195895 | 13MM THICKNESS 79/83 TRAY | In distribution |
| 195598 | 9MM THICKNESS 63MM TRAY | In distribution |
| 195796 | 12MM THICKNESS 87/91 TRAY | In distribution |
| 195628 | 11MM THICKNESS 79MM TRAY | In distribution |
| 195279 | 91 MM | In distribution |
| 195757 | 75 MM | In distribution |
| 195552 | 12MM THICKNESS 69/71 TRAY | In distribution |
| 195553 | 13MM THICKNESS 69/71 TRAY | In distribution |
| 195593 | 11MM THICKNESS 59MM TRAY | In distribution |
| 195908 | 60 MM | In distribution |
| 195926 | 75 MM | In distribution |
| 195626 | 9MM THICKNESS 79MM TRAY | In distribution |
| 195287 | 75 MM | In distribution |
| 195290 | 87 MM | In distribution |
| 195565 | 11MM THICKNESS 79MM TRAY | In distribution |
| 195621 | 11MM THICKNESS 73/75 TRAY | In distribution |
| 195828 | 9MM THICKNESS 87/91 TRAY | In distribution |
| 195564 | 10MM THICKNESS 79MM TRAY | In distribution |
| 195864 | 10MM THICKNESS 87/91 TRAY | In distribution |
| 195632 | 16MM THICKNESS 79MM TRAY | In distribution |
| 195547 | 14MM THICKNESS 65/67 TRAY | In distribution |
| 195571 | 10MM THICKNESS 83MM TRAY | In distribution |
| 195627 | 10MM THICKNESS 79MM TRAY | In distribution |
| 195602 | 13MM THICKNESS 63MM TRAY | In distribution |
| 195867 | 13MM THICKNESS 87/91 TRAY | In distribution |
| 195857 | 10MM THICKNESS 79/83 TRAY | In distribution |
| 195605 | 9MM THICKNESS 65/67 TRAY | In distribution |
| 195809 | 11MM THICKNESS 63/65/67 TRAY | In distribution |
| 195568 | 14MM THICKNESS 79MM TRAY | In distribution |
| 195620 | 10MM THICKNESS 73/75 TRAY | In distribution |
| 195897 | 16MM THICKNESS 79/83 TRAY | In distribution |
| 195847 | 14MM THICKNESS 63/65/67 TRAY | In distribution |
| 195555 | 16MM THICKNESS 69/71 TRAY | In distribution |
| 195825 | 13MM THICKNESS 79/83 TRAY | In distribution |
| 195583 | 16MM THICKNESS 87MM TRAY | In distribution |
| 195787 | 10MM THICKNESS 79/83 TRAY | In distribution |
| 195892 | 10MM THICKNESS 79/83 TRAY | In distribution |
| 195939 | 77.5 MM | In distribution |
| 195577 | 9MM THICKNESS 87MM TRAY | In distribution |
| 195614 | 11MM THICKNESS 69/71 TRAY | In distribution |
| 195575 | 14MM THICKNESS 83MM TRAY | In distribution |
| 195913 | 72.5 MM | In distribution |
| 195545 | 12MM THICKNESS 65/67 TRAY | In distribution |
| 195763 | 69/71 MM 73/75 MM | In distribution |
| 195582 | 14MM THICKNESS 87MM TRAY | In distribution |
| 195918 | 55 MM | In distribution |
| 195623 | 13MM THICKNESS 73/75 TRAY | In distribution |
| 195834 | 16MM THICKNESS 87/91 TRAY | In distribution |
| 195540 | 14MM THICKNESS 63MM TRAY | In distribution |
| 195833 | 14MM THICKNESS 87/91 TRAY | In distribution |
| 195891 | 9MM THICKNESS 79/83 TRAY | In distribution |
| 195885 | 10MM THICKNESS 69/71/73/75 TRAY | In distribution |
| 195546 | 13MM THICKNESS 65/67 TRAY | In distribution |
| 195615 | 12MM THICKNESS 69/71 TRAY | In distribution |
| 195755 | 71 MM | In distribution |
| 195771 | 16MM THICKNESS 59MM TRAY | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Vanguard XP® Instrumentation | Biomet Orthopedics | 130 |
| Vanguard® 360 Instrument | Biomet Orthopedics | 98 |
| Biomet® Knee System | Biomet Orthopedics | 94 |
| Maxim Knee System | Biomet Orthopedics | 73 |
| Vanguard Knee System | Biomet Orthopedics | 49 |
| 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
35 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 | 2019-08-15 | Class II | Manufacturing material removal | The locking bar not fully engaging | 45 units | 2021-04-16 |
| Biomet, Inc. | 510(k) number | 2019-08-15 | Class II | Manufacturing material removal | The locking bar not fully engaging | 322 unit | 2021-04-16 |
| Biomet, Inc. | 510(k) number | 2019-08-15 | Class II | Manufacturing material removal | The locking bar not fully engaging | 375 units | 2021-04-16 |
| Biomet, Inc. | 510(k) number | 2019-08-15 | Class II | Manufacturing material removal | The locking bar not fully engaging | 567 units | 2021-04-16 |
| Biomet, Inc. | 510(k) number | 2019-08-15 | Class II | Manufacturing material removal | The locking bar not fully engaging | 498 units | 2021-04-16 |
| Biomet, Inc. | 510(k) number | 2019-08-15 | Class II | Manufacturing material removal | The locking bar not fully engaging | 454 units | 2021-04-16 |
| Biomet, Inc. | 510(k) number | 2019-08-15 | Class II | Manufacturing material removal | The locking bar not fully engaging | 327 units | 2021-04-16 |
| Biomet, Inc. | 510(k) number | 2019-08-15 | Class II | Manufacturing material removal | The locking bar not fully engaging | 369 units | 2021-04-16 |
| Biomet, Inc. | 510(k) number | 2019-08-15 | Class II | Manufacturing material removal | The locking bar not fully engaging | 319 units | 2021-04-16 |
| Biomet, Inc. | 510(k) number | 2019-08-15 | Class II | Manufacturing material removal | The locking bar not fully engaging | 180 units | 2021-04-16 |
| Biomet, Inc. | 510(k) number | 2019-08-15 | Class II | Manufacturing material removal | The locking bar not fully engaging | 78 units | 2021-04-16 |
| Biomet, Inc. | 510(k) number | 2019-08-15 | Class II | Manufacturing material removal | The locking bar not fully engaging | 82 units | 2021-04-16 |
| Biomet, Inc. | 510(k) number | 2019-08-15 | Class II | Manufacturing material removal | The locking bar not fully engaging | 2 units | 2021-04-16 |
| Biomet, Inc. | 510(k) number | 2019-08-15 | Class II | Manufacturing material removal | The locking bar not fully engaging | 86 units | 2021-04-16 |
| Biomet, Inc. | 510(k) number | 2019-08-15 | Class II | Manufacturing material removal | The locking bar not fully engaging | 90 units | 2021-04-16 |
| Biomet, Inc. | 510(k) number | 2019-08-15 | Class II | Manufacturing material removal | The locking bar not fully engaging | 384 units | 2021-04-16 |
| Biomet, Inc. | 510(k) number | 2019-08-15 | Class II | Manufacturing material removal | The locking bar not fully engaging | 2021-04-16 | |
| Biomet, Inc. | 510(k) number | 2019-08-15 | Class II | Manufacturing material removal | The locking bar not fully engaging | 973 units | 2021-04-16 |
| Biomet, Inc. | 510(k) number | 2019-08-15 | Class II | Manufacturing material removal | The locking bar not fully engaging | 906 units | 2021-04-16 |
| Biomet, Inc. | 510(k) number | 2019-08-15 | Class II | Manufacturing material removal | The locking bar not fully engaging | 1221 units | 2021-04-16 |
| Biomet, Inc. | 510(k) number | 2019-08-15 | Class II | Manufacturing material removal | The locking bar not fully engaging | 1282 units | 2021-04-16 |
| Biomet, Inc. | 510(k) number | 2019-08-15 | Class II | Manufacturing material removal | The locking bar not fully engaging | 1210 units | 2021-04-16 |
| Biomet, Inc. | 510(k) number | 2019-08-15 | Class II | Manufacturing material removal | The locking bar not fully engaging | 857 units | 2021-04-16 |
| Biomet, Inc. | 510(k) number | 2019-08-15 | Class II | Manufacturing material removal | The locking bar not fully engaging | 480 units | 2021-04-16 |
| Biomet, Inc. | 510(k) number | 2019-08-15 | Class II | Manufacturing material removal | The locking bar not fully engaging | 8 units | 2021-04-16 |
| Biomet, Inc. | 510(k) number | 2019-08-15 | Class II | Manufacturing material removal | The locking bar not fully engaging | 43 units | 2021-04-16 |
| Biomet, Inc. | 510(k) number | 2019-08-15 | Class II | Manufacturing material removal | The locking bar not fully engaging | 74 units | 2021-04-16 |
| Biomet, Inc. | 510(k) number | 2019-08-15 | Class II | Manufacturing material removal | The locking bar not fully engaging | 123 units | 2021-04-16 |
| Biomet, Inc. | 510(k) number | 2019-08-15 | Class II | Manufacturing material removal | The locking bar not fully engaging | 2021-04-16 | |
| Biomet, Inc. | 510(k) number | 2019-08-15 | Class II | Manufacturing material removal | The locking bar not fully engaging | 84 units | 2021-04-16 |
| Biomet, Inc. | 510(k) number | 2019-08-15 | Class II | Manufacturing material removal | The locking bar not fully engaging | 110 units | 2021-04-16 |
| Biomet, Inc. | 510(k) number | 2019-08-15 | Class II | Manufacturing material removal | The locking bar not fully engaging | 99 units | 2021-04-16 |
| Biomet, Inc. | 510(k) number | 2019-08-15 | Class II | Manufacturing material removal | The locking bar not fully engaging | 49 units | 2021-04-16 |
| Biomet, Inc. | 510(k) number | 2019-08-15 | Class II | Manufacturing material removal | The locking bar not fully engaging | 2021-04-16 | |
| Biomet, Inc. | 510(k) number | 2016-02-05 | Class II | Device Design | The anterior/posterior (AP) dimension may be oversized by 0.016. If the femoral component does not fit as tightly as intended, bony ingrowth may not occur causing loosening of the femoral component. A revision surgery may be necessary. | 890 | 2017-03-28 |
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.