Vanguard Complete Knee System
117 catalogue numbers from 195952, listed by Biomet Orthopedics, United States, under Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer. 12 manufacturers in China are registered for this product code.
12manufacturers in China registered for this device type
117catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (3), Zhejiang (2). 8 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 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| 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 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Biomet Orthopedics, United States |
|---|---|
| FDA product code | MBH |
| Device type | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3565 |
| 510(k) | K141407 |
| Record published | 2015-10-24 |
| Record revised | 2025-05-30 (version 6) |
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 |
|---|---|---|
| 195952 | 80 MM | In distribution |
| 195580 | 12MM THICKNESS 87MM TRAY | In distribution |
| 195288 | 79 MM | In distribution |
| 195856 | 9MM THICKNESS 79/83 TRAY | In distribution |
| 195558 | 11MM THICKNESS 73/75 TRAY | In distribution |
| 195884 | 9MM THICKNESS 69/71/73/75 TRAY | In distribution |
| 195642 | 11MM THICKNESS 87MM TRAY | In distribution |
| 195638 | 14MM THICKNESS 83MM TRAY | In distribution |
| 195643 | 12MM THICKNESS 87MM TRAY | In distribution |
| 195592 | 10MM THICKNESS 59MM TRAY | In distribution |
| 195772 | 9MM THICKNESS 63/65/67 TRAY | In distribution |
| 195601 | 12MM THICKNESS 63MM TRAY | In distribution |
| 195570 | 9MM THICKNESS 83MM TRAY | In distribution |
| 195775 | 12MM THICKNESS 63/65/67 TRAY | In distribution |
| 195583 | 16MM THICKNESS 87MM TRAY | In distribution |
| 195791 | 14MM THICKNESS 79/83 TRAY | In distribution |
| 195637 | 13MM THICKNESS 83MM TRAY | In distribution |
| 195848 | 16MM THICKNESS 63/65/67 TRAY | In distribution |
| 195538 | 12MM THICKNESS 63MM TRAY | In distribution |
| 195778 | 16MM THICKNESS 63/65/67 TRAY | In distribution |
| 195630 | 13MM THICKNESS 79MM TRAY | In distribution |
| 195842 | 9MM THICKNESS 63/65/67 TRAY | In distribution |
| 195767 | 11MM THICKNESS 59 TRAY | In distribution |
| 195561 | 14MM THICKNESS 73/75 TRAY | In distribution |
| 195651 | 13MM THICKNESS 91MM TRAY | In distribution |
| 195554 | 14MM THICKNESS 69/71 TRAY | In distribution |
| 195603 | 14MM THICKNESS 63MM TRAY | In distribution |
| 195821 | 9MM THICKNESS 79/83 TRAY | In distribution |
| 195557 | 10MM THICKNESS 73/75 TRAY | In distribution |
| 195826 | 14MM THICKNESS 79/83 TRAY | In distribution |
| 195943 | 57.5 MM | In distribution |
| 195921 | 62.5 MM | In distribution |
| 195621 | 11MM THICKNESS 73/75 TRAY | In distribution |
| 195609 | 13MM THICKNESS 65/67 TRAY | In distribution |
| 195581 | 13MM THICKNESS 87MM TRAY | In distribution |
| 195843 | 10MM THICKNESS 63/65/67 TRAY | In distribution |
| 195566 | 12MM THICKNESS 79MM TRAY | In distribution |
| 195823 | 11MM THICKNESS 79/83 TRAY | In distribution |
| 195600 | 11MM THICKNESS 63MM TRAY | In distribution |
| 195272 | 69 MM | In distribution |
| 195607 | 11MM THICKNESS 65/67 TRAY | In distribution |
| 195624 | 14MM THICKNESS 73/75 TRAY | In distribution |
| 195786 | 9MM THICKNESS 79/83 TRAY | In distribution |
| 195606 | 10MM THICKNESS 65/67 TRAY | In distribution |
| 195633 | 9MM THICKNESS 83MM TRAY | In distribution |
| 195613 | 10MM THICKNESS 69/71 TRAY | In distribution |
| 195647 | 9MM THICKNESS 91MM TRAY | In distribution |
| 195618 | 16MM THICKNESS 69/71MM TRAY | In distribution |
| 195862 | 16MM THICKNESS 79/83 TRAY | In distribution |
| 195917 | 52.5 MM | In distribution |
| 195576 | 16MM THICKNESS 83MM TRAY | In distribution |
| 195649 | 11MM THICKNESS 91MM TRAY | In distribution |
| 195607 | 11MM THICKNESS 65/67 TRAY | In distribution |
| 195645 | 14MM THICKNESS 87MM TRAY | In distribution |
| 195588 | 13MM THICKNESS 91MM TRAY | In distribution |
| 195271 | 67 MM | In distribution |
| 195887 | 12MM THICKNESS 69/71/73/75 TRAY | In distribution |
| 195898 | 9MM THICKNESS 87/91 TRAY | In distribution |
| 195790 | 13MM THICKNESS 79/83 TRAY | In distribution |
| 195774 | 11MM THICKNESS 63/65/67 TRAY | In distribution |
| 195631 | 14MM THICKNESS 79MM TRAY | In distribution |
| 195553 | 13MM THICKNESS 69/71 TRAY | In distribution |
| 195750 | 59 MM | In distribution |
| 195579 | 11MM THICKNESS 87MM TRAY | In distribution |
| 195751 | 63 MM | In distribution |
| 195539 | 13MM THICKNESS 63MM TRAY | In distribution |
| 195815 | 10MM THICKNESS 69/71/73/75 TRAY | In distribution |
| 195641 | 10MM THICKNESS 87MM TRAY | In distribution |
| 195934 | 65 MM | In distribution |
| 195845 | 12MM THICKNESS 63/65/67 TRAY | In distribution |
| 195931 | 57.5 MM | In distribution |
| 195584 | 9MM THICKNESS 91MM TRAY | In distribution |
| 195616 | 13MM THICKNESS 69/71 TRAY | In distribution |
| 195564 | 10MM THICKNESS 79MM TRAY | In distribution |
| 195559 | 12MM THICKNESS 73/75 TRAY | In distribution |
| 195554 | 14MM THICKNESS 69/71 TRAY | In distribution |
| 195275 | 75 MM | In distribution |
| 195868 | 14MM THICKNESS 87/91 TRAY | In distribution |
| 195611 | 16MM THICKNESS 65/67 TRAY | In distribution |
| 195545 | 12MM THICKNESS 65/67 TRAY | In distribution |
| 195758 | 79 MM | In distribution |
| 195535 | 9MM THICKNESS 63MM TRAY | In distribution |
| 195863 | 9MM THICKNESS 87/91 TRAY | In distribution |
| 195643 | 12MM THICKNESS 87MM TRAY | In distribution |
| 195783 | 13MM THICKNESS 69/71/73/75 TRAY | In distribution |
| 195625 | 16MM THICKNESS 73/75 TRAY | In distribution |
| 195617 | 14MM THICKNESS 69/71 TRAY | In distribution |
| 195600 | 11MM THICKNESS 63MM TRAY | In distribution |
| 195589 | 14MM THICKNESS 91MM TRAY | In distribution |
| 195609 | 13MM THICKNESS 65/67 TRAY | In distribution |
| 195536 | 10MM THICKNESS 63MM TRAY | In distribution |
| 195946 | 65 MM | In distribution |
| 195638 | 14MM THICKNESS 83MM TRAY | In distribution |
| 195653 | 16MM THICKNESS 91MM TRAY | In distribution |
| 195636 | 12MM THICKNESS 83MM TRAY | In distribution |
| 195291 | 91 MM | In distribution |
| 195886 | 11MM THICKNESS 69/71/73/75 TRAY | In distribution |
| 195890 | 16MM THICKNESS 69/71/73/75 TRAY | In distribution |
| 195634 | 10MM THICKNESS 83MM TRAY | In distribution |
| 195529 | 10MM THICKNESS 59MM TRAY | In distribution |
| 195923 | 67.5 MM | In distribution |
| 195576 | 16MM THICKNESS 83MM TRAY | In distribution |
| 195610 | 14MM THICKNESS 65/67 TRAY | In distribution |
| 195915 | 77.5 MM | In distribution |
| 195532 | 13MM THICKNESS 59MM TRAY | In distribution |
| 195581 | 13MM THICKNESS 87MM TRAY | In distribution |
| 195951 | 77.5 MM | In distribution |
| 195543 | 10MM THICKNESS 65/67 TRAY | In distribution |
| 195619 | 9MM THICKNESS 73/75 TRAY | In distribution |
| 195800 | 9MM THICKNESS 59 TRAY | In distribution |
| 195781 | 11MM THICKNESS 69/71/73/75 TRAY | In distribution |
| 195793 | 9MM THICKNESS 87/91 TRAY | In distribution |
| 195789 | 12MM THICKNESS 79/83 TRAY | In distribution |
| 195277 | 83 MM | In distribution |
| 195816 | 11MM THICKNESS 69/71/73/75 TRAY | In distribution |
| 195811 | 13MM THICKNESS 63/65/67 TRAY | In distribution |
| 195546 | 13MM THICKNESS 65/67 TRAY | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Prophecy | Microport Orthopedics Inc. | 4,272 |
| Triathlon | Howmedica Osteonics Corp | 712 |
| Instrument | Howmedica Osteonics Corp | 709 |
| Persona® Vivacit-E® | Zimmer, Inc. | 499 |
| Arthrex® | Arthrex, Inc. | 494 |
| Persona® | Zimmer, Inc. | 441 |
| Legion | Smith & Nephew, Inc. | 397 |
| U2 Total Knee System | United Orthopedic Corp. | 286 |
| Attune | Depuy (Ireland) | 234 |
| DJO Surgical | Encore Medical, L.P. | 191 |
| Vanguard XP Instrumentation | Biomet Orthopedics | 150 |
| Truliant® | Exactech, Inc. | 142 |
Showing 12 of 948. All products under Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, 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.