Vanguard Complete Knee System
153 catalogue numbers from 195780, listed by Biomet Orthopedics, United States, under Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive. 8 manufacturers in China are registered for this product code.
8manufacturers in China registered for this device type
153catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (4), Shanghai (2), Zhejiang (1). 3 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 |
| b-ONE Medical (Beijing) Co., Ltd. | Beijing | Beijing | Contract manufacturer | 7 |
| 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 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Biomet Orthopedics, United States |
|---|---|
| FDA product code | OIY |
| Device type | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3560 |
| 510(k) | K132873 |
| Record published | 2015-10-24 |
| Record revised | 2025-05-30 (version 9) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Height 10 to 20 mm; length 59 to 87 mm; width 67 to 91 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 195780 | 10MM THICKNESS 69/71/73/75 TRAY | In distribution |
| 195768 | 12MM THICKNESS 59 TRAY | In distribution |
| 195817 | 12MM THICKNESS 69/71/73/75 TRAY | In distribution |
| 195619 | 9MM THICKNESS 73/75 TRAY | In distribution |
| 195610 | 14MM THICKNESS 65/67 TRAY | In distribution |
| 195598 | 9MM THICKNESS 63MM TRAY | In distribution |
| 195797 | 13MM THICKNESS 87/91 TRAY | In distribution |
| 195634 | 10MM THICKNESS 83MM TRAY | In distribution |
| 195888 | 13MM THICKNESS 69/71/73/75 TRAY | In distribution |
| 195560 | 13MM THICKNESS 73/75 TRAY | In distribution |
| SSI004324 | Size 40 | In distribution |
| 195538 | 12MM THICKNESS 63MM TRAY | In distribution |
| 195537 | 11MM THICKNESS 63MM TRAY | In distribution |
| 195916 | 80 MM | In distribution |
| 195605 | 9MM THICKNESS 65/67 TRAY | In distribution |
| 195807 | 9MM THICKNESS 63/65/67 TRAY | In distribution |
| 195769 | 13MM THICKNESS 59 TRAY | In distribution |
| SSI002639 | Width 75 mm | In distribution |
| SSI003225 | Height 11 mm | In distribution |
| 195528 | 9MM THICKNESS 59MM TRAY | In distribution |
| 195784 | 14MM THICKNESS 69/71/73/75 TRAY | In distribution |
| 195919 | 57.5 MM | In distribution |
| 195579 | 11MM THICKNESS 87MM TRAY | In distribution |
| 195902 | 13MM THICKNESS 87/91 TRAY | In distribution |
| SSI003114 | Width 67 mm | In distribution |
| 195575 | 14MM THICKNESS 83MM TRAY | In distribution |
| 195274 | 73 MM | In distribution |
| 195601 | 12MM THICKNESS 63MM TRAY | In distribution |
| 195650 | 12MM THICKNESS 91MM TRAY | In distribution |
| 195624 | 14MM THICKNESS 73/75 TRAY | In distribution |
| 195851 | 11MM THICKNESS 69/71/73/75 TRAY | In distribution |
| 195820 | 16MM THICKNESS 69/71/73/75 TRAY | In distribution |
| SSI003227 | Height 11 mm | In distribution |
| 195941 | 52.5 MM | In distribution |
| SSI002637 | Width 67 mm | In distribution |
| 195765 | 9MM THICKNESS 59MM TRAY | In distribution |
| 195801 | 10MM THICKNESS 59 TRAY | In distribution |
| 195905 | 52.5 MM | In distribution |
| 195872 | 11MM THICKNESS 59 TRAY | In distribution |
| 195819 | 14MM THICKNESS 69/71/73/75 TRAY | In distribution |
| 195909 | 62.5 MM | In distribution |
| 195950 | 75 MM | In distribution |
| 195588 | 13MM THICKNESS 91MM TRAY | In distribution |
| 195599 | 10MM THICKNESS 63MM TRAY | In distribution |
| 195540 | 14MM THICKNESS 63MM TRAY | In distribution |
| 195870 | 9MM THICKNESS 59 TRAY | In distribution |
| 195603 | 14MM THICKNESS 63MM TRAY | In distribution |
| 195878 | 10MM THICKNESS 63/65/67 TRAY | In distribution |
| 195278 | 87 MM | In distribution |
| 195844 | 11MM THICKNESS 63/65/67 TRAY | In distribution |
| 195858 | 11MM THICKNESS 79/83 TRAY | In distribution |
| SSI002641 | Width 83 mm | In distribution |
| 195798 | 14MM THICKNESS 87/91 TRAY | In distribution |
| 195623 | 13MM THICKNESS 73/75 TRAY | In distribution |
| 195904 | 16MM THICKNESS 87/91 TRAY | In distribution |
| 195649 | 11MM THICKNESS 91MM TRAY | In distribution |
| 195635 | 11MM THICKNESS 83MM TRAY | In distribution |
| 195642 | 11MM THICKNESS 87MM TRAY | In distribution |
| 195276 | 79 MM | In distribution |
| 195578 | 10MM THICKNESS 87MM TRAY | In distribution |
| 195606 | 10MM THICKNESS 65/67 TRAY | In distribution |
| 195533 | 14MM THICKNESS 59MM TRAY | In distribution |
| 195622 | 12MM THICKNESS 73/75 TRAY | In distribution |
| 195893 | 11MM THICKNESS 79/83 TRAY | In distribution |
| 195625 | 16MM THICKNESS 73/75 TRAY | In distribution |
| SSI002635 | Length 59 mm | In distribution |
| 195877 | 9MM THICKNESS 63/65/67 TRAY | In distribution |
| 195645 | 14MM THICKNESS 87MM TRAY | In distribution |
| 195827 | 16MM THICKNESS 79/83 TRAY | In distribution |
| 195574 | 13MM THICKNESS 83MM TRAY | In distribution |
| 195647 | 9MM THICKNESS 91MM TRAY | In distribution |
| 195906 | 55 MM | In distribution |
| 195566 | 12MM THICKNESS 79MM TRAY | In distribution |
| 195818 | 13MM THICKNESS 69/71/73/75 TRAY | In distribution |
| 195637 | 13MM THICKNESS 83MM TRAY | In distribution |
| 195646 | 16MM THICKNESS 87MM TRAY | In distribution |
| 195776 | 13MM THICKNESS 63/65/67 TRAY | In distribution |
| 195753 | 67 MM | In distribution |
| 195640 | 9MM THICKNESS 87MM TRAY | In distribution |
| 195629 | 12MM THICKNESS 79MM TRAY | In distribution |
| 195618 | 16MM THICKNESS 69/71MM TRAY | In distribution |
| 195799 | 16MM THICKNESS 87/91 TRAY | In distribution |
| 195802 | 11MM THICKNESS 59 TRAY | In distribution |
| 195792 | 16MM THICKNESS 79/83 TRAY | In distribution |
| 195880 | 12MM THICKNESS 63/65/67 TRAY | In distribution |
| 195595 | 13MM THICKNESS 59MM TRAY | In distribution |
| 195644 | 13MM THICKNESS 87MM TRAY | In distribution |
| 195547 | 14MM THICKNESS 65/67 TRAY | In distribution |
| 195270 | 65 MM | In distribution |
| 195562 | 16MM THICKNESS 73/75 TRAY | In distribution |
| 195852 | 12MM THICKNESS 69/71/73/75 TRAY | In distribution |
| 195945 | 62.5 MM | In distribution |
| 195558 | 11MM THICKNESS 73/75 TRAY | In distribution |
| 195903 | 14MM THICKNESS 87/91 TRAY | In distribution |
| 195894 | 12MM THICKNESS 79/83 TRAY | In distribution |
| 195831 | 12MM THICKNESS 87/91 TRAY | In distribution |
| 195567 | 13MM THICKNESS 79MM TRAY | In distribution |
| 195803 | 12MM THICKNESS 59 TRAY | In distribution |
| 195883 | 16MM THICKNESS 63/65/67 TRAY | In distribution |
| 195766 | 10MM THICKNESS 59MM TRAY | In distribution |
| SSI001057 | Size 72.5mm | In distribution |
| 195859 | 12MM THICKNESS 79/83 TRAY | In distribution |
| 195854 | 14MM THICKNESS 69/71/73/75 TRAY | In distribution |
| 195570 | 9MM THICKNESS 83MM TRAY | In distribution |
| 195925 | 72.5 MM | In distribution |
| 195759 | 83 MM | In distribution |
| 195907 | 57.5 MM | In distribution |
| 195284 | 69 MM | In distribution |
| 195930 | 55 MM | In distribution |
| 195608 | 12MM THICKNESS 65/67 TRAY | In distribution |
| 195899 | 10MM THICKNESS 87/91 TRAY | In distribution |
| 195752 | 65 MM | In distribution |
| SSI002357 | 71/75 mm | In distribution |
| 195273 | 71 MM | In distribution |
| 195764 | 79/83 MM 87/91 MM | In distribution |
| SSI004320 | Size 28 | In distribution |
| SSI002643 | Width 91 mm | In distribution |
| SSI002373 | 63/67 mm | In distribution |
| 195935 | 67.5 MM | In distribution |
| 195604 | 16MM THICKNESS 63MM TRAY | In distribution |
| 195563 | 9MM THICKNESS 79MM TRAY | In distribution |
| 195639 | 16MM THICKNESS 83MM TRAY | In distribution |
| 195542 | 9MM THICKNESS 65/67 TRAY | In distribution |
| SSI003223 | Height 11 mm | In distribution |
| 195824 | 12MM THICKNESS 79/83 TRAY | In distribution |
| SSI002359 | 79/83 mm | In distribution |
| 195889 | 14MM THICKNESS 69/71/73/75 TRAY | In distribution |
| SSI002345 | 79/83 mm | In distribution |
| 195597 | 16MM THICKNESS 59MM TRAY | In distribution |
| 195648 | 10MM THICKNESS 91MM TRAY | In distribution |
| 195777 | 14MM THICKNESS 63/65/67 TRAY | In distribution |
| 195910 | 65 MM | In distribution |
| 195613 | 10MM THICKNESS 69/71 TRAY | In distribution |
| 195853 | 13MM THICKNESS 69/71/73/75 TRAY | In distribution |
| 195268 | 59 MM | In distribution |
| 195596 | 14MM THICKNESS 59MM TRAY | In distribution |
| 195571 | 10MM THICKNESS 83MM TRAY | In distribution |
| 195550 | 10MM THICKNESS 69/71 TRAY | In distribution |
| 195836 | 10MM THICKNESS 59 TRAY | In distribution |
| 195754 | 69 MM | In distribution |
| SSI004322 | Size 34 | In distribution |
| 195626 | 9MM THICKNESS 79MM TRAY | In distribution |
| 195556 | 9MM THICKNESS 73/75 TRAY | In distribution |
| 195806 | 16MM THICKNESS 59 TRAY | In distribution |
| 195549 | 9MM THICKNESS 69/71 TRAY | In distribution |
| 195782 | 12MM THICKNESS 69/71/73/75 TRAY | In distribution |
| 195584 | 9MM THICKNESS 91MM TRAY | In distribution |
| 195559 | 12MM THICKNESS 73/75 TRAY | In distribution |
| SSI003116 | Width 67 mm | In distribution |
| 195794 | 10MM THICKNESS 87/91 TRAY | In distribution |
| SSI002347 | 63/67 mm | In distribution |
| 195537 | 11MM THICKNESS 63MM TRAY | In distribution |
| 195620 | 10MM THICKNESS 73/75 TRAY | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Persona® | Zimmer, Inc. | 552 |
| DJO Surgical | Encore Medical, L.P. | 415 |
| Genflex2 Total Knee System | Globus Medical, Inc. | 389 |
| Persona® Vivacit-E® | Zimmer, Inc. | 332 |
| Truliant, Activit-E | Exactech, Inc. | 272 |
| TriVerse Meniscal Insert PS | Signature Orthopaedics PTY Limited | 220 |
| U2™ Knee | United Orthopedic Corp. | 195 |
| BKS E-Vitalize | Ortho Development Corp. | 193 |
| Vanguard XP Instrumentation | Biomet Orthopedics | 169 |
| Attune | Depuy (Ireland) | 161 |
| EXp Tibial Inserts and Patellar Components | Globus Medical, Inc. | 144 |
| TriVerse Meniscal Insert AS | Signature Orthopaedics PTY Limited | 126 |
Showing 12 of 102. All products under Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
Recalls Naming This Product
42 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 | 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 | 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 | 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 | 2018-05-11 | 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 |
Showing 40 of 42.
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.