Vanguard Complete Knee System
124 catalogue numbers from SSI001058, listed by Biomet Orthopedics, United States, under Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer. 21 manufacturers in China are registered for this product code.
21manufacturers in China registered for this device type
124catalogue numbers in this listing
2510(k) clearances naming this product 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 | Biomet Orthopedics, 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 |
| 510(k) | K113550 |
| Record published | 2016-12-22 |
| Record revised | 2025-05-30 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| 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 18 mm; length 59 to 87 mm; width 67 to 91 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SSI001058 | Size 72.5mm | In distribution |
| 195920 | 60 MM | In distribution |
| 195590 | 16MM THICKNESS 91MM TRAY | In distribution |
| 195813 | 16MM THICKNESS 63/65/67 TRAY | In distribution |
| 195875 | 14MM THICKNESS 59 TRAY | In distribution |
| SSI004323 | Size 37 | In distribution |
| 195788 | 11MM THICKNESS 79/83 TRAY | In distribution |
| 195652 | 14MM THICKNESS 91MM TRAY | In distribution |
| SSI002642 | Height 13 mm | In distribution |
| SSI003224 | 63/67 MM, PS/PS+/CR-L RG | In distribution |
| 195594 | 12MM THICKNESS 59MM TRAY | In distribution |
| 195285 | 71 MM | In distribution |
| 195785 | 16MM THICKNESS 69/71/73/75 TRAY | In distribution |
| 195770 | 14MM THICKNESS 59 TRAY | In distribution |
| 195586 | 11MM THICKNESS 91MM TRAY | In distribution |
| 195556 | 9MM THICKNESS 73/75 TRAY | In distribution |
| 195832 | 13MM THICKNESS 87/91 TRAY | In distribution |
| 195795 | 11MM THICKNESS 87/91 TRAY | In distribution |
| 195591 | 9MM THICKNESS 59MM TRAY | In distribution |
| 195830 | 11MM THICKNESS 87/91 TRAY | In distribution |
| 195563 | 9MM THICKNESS 79MM TRAY | In distribution |
| SSI002636 | Height 13 mm | In distribution |
| 195896 | 14MM THICKNESS 79/83 TRAY | In distribution |
| 195622 | 12MM THICKNESS 73/75 TRAY | In distribution |
| 195866 | 12MM THICKNESS 87/91 TRAY | In distribution |
| 195608 | 12MM THICKNESS 65/67 TRAY | In distribution |
| 195568 | 14MM THICKNESS 79MM TRAY | In distribution |
| SSI002640 | Height 13 mm | In distribution |
| 195761 | 91 MM | In distribution |
| 195555 | 16MM THICKNESS 69/71 TRAY | In distribution |
| 195552 | 12MM THICKNESS 69/71 TRAY | In distribution |
| 195569 | 16MM THICKNESS 79MM TRAY | In distribution |
| 195544 | 11MM THICKNESS 65/67 TRAY | In distribution |
| 195760 | 87 MM | In distribution |
| 195646 | 16MM THICKNESS 87MM TRAY | In distribution |
| 195636 | 12MM THICKNESS 83MM TRAY | In distribution |
| 195901 | 12MM THICKNESS 87/91 TRAY | In distribution |
| 195932 | 60 MM | In distribution |
| 195543 | 10MM THICKNESS 65/67 TRAY | In distribution |
| SSI004319 | Size 25 | In distribution |
| 195269 | 63 MM | In distribution |
| 195861 | 14MM THICKNESS 79/83 TRAY | In distribution |
| 195938 | 75 MM | In distribution |
| 195876 | 16MM THICKNESS 59 TRAY | In distribution |
| 195922 | 65 MM | In distribution |
| 195928 | 80 MM | In distribution |
| 195587 | 12MM THICKNESS 91MM TRAY | In distribution |
| 195829 | 10MM THICKNESS 87/91 TRAY | In distribution |
| SSI002638 | Height 13 mm | In distribution |
| 195282 | 65 MM | In distribution |
| 195587 | 12MM THICKNESS 91MM TRAY | In distribution |
| 195578 | 10MM THICKNESS 87MM TRAY | In distribution |
| 195838 | 12MM THICKNESS 59 TRAY | In distribution |
| SSI003115 | Height 18 mm | In distribution |
| SSI002356 | Height 12 mm | In distribution |
| 195948 | 70 MM | In distribution |
| SSI003226 | 71/75 MM, PS/PS+/CR-L RG | In distribution |
| 195942 | 55 MM | In distribution |
| 195569 | 16MM THICKNESS 79MM TRAY | In distribution |
| 195936 | 70 MM | In distribution |
| 195572 | 11MM THICKNESS 83MM TRAY | In distribution |
| 195927 | 77.5 MM | In distribution |
| 195812 | 14MM THICKNESS 63/65/67 TRAY | In distribution |
| 195531 | 12MM THICKNESS 59MM TRAY | In distribution |
| 195653 | 16MM THICKNESS 91MM TRAY | In distribution |
| 195631 | 14MM THICKNESS 79MM TRAY | In distribution |
| 195589 | 14MM THICKNESS 91MM TRAY | In distribution |
| 195804 | 13MM THICKNESS 59 TRAY | In distribution |
| 195839 | 13MM THICKNESS 59 TRAY | In distribution |
| 195586 | 11MM THICKNESS 91MM TRAY | In distribution |
| 195585 | 10MM THICKNESS 91MM TRAY | In distribution |
| 195865 | 11MM THICKNESS 87/91 TRAY | In distribution |
| 195648 | 10MM THICKNESS 91MM TRAY | In distribution |
| 195536 | 10MM THICKNESS 63MM TRAY | In distribution |
| 195539 | 13MM THICKNESS 63MM TRAY | In distribution |
| 195651 | 13MM THICKNESS 91MM TRAY | In distribution |
| 195650 | 12MM THICKNESS 91MM TRAY | In distribution |
| SSI002644 | Height 13 mm | In distribution |
| 195561 | 14MM THICKNESS 73/75 TRAY | In distribution |
| 195565 | 11MM THICKNESS 79MM TRAY | In distribution |
| 195541 | 16MM THICKNESS 63MM TRAY | In distribution |
| 195617 | 14MM THICKNESS 69/71 TRAY | In distribution |
| 195604 | 16MM THICKNESS 63MM TRAY | In distribution |
| 195616 | 13MM THICKNESS 69/71 TRAY | In distribution |
| 195639 | 16MM THICKNESS 83MM TRAY | In distribution |
| 195773 | 10MM THICKNESS 63/65/67 TRAY | In distribution |
| 195949 | 72.5 MM | In distribution |
| 195599 | 10MM THICKNESS 63MM TRAY | In distribution |
| 195635 | 11MM THICKNESS 83MM TRAY | In distribution |
| 195549 | 9MM THICKNESS 69/71 TRAY | In distribution |
| 195548 | 16MM THICKNESS 65/67 TRAY | In distribution |
| 195835 | 9MM THICKNESS 59 TRAY | In distribution |
| 195805 | 14MM THICKNESS 59 TRAY | In distribution |
| 195573 | 12MM THICKNESS 83MM TRAY | In distribution |
| 195557 | 10MM THICKNESS 73/75 TRAY | In distribution |
| 195756 | 73 MM | In distribution |
| 195542 | 9MM THICKNESS 65/67 TRAY | In distribution |
| 195627 | 10MM THICKNESS 79MM TRAY | In distribution |
| 195644 | 13MM THICKNESS 87MM TRAY | In distribution |
| 195551 | 11MM THICKNESS 69/71 TRAY | In distribution |
| 195582 | 14MM THICKNESS 87MM TRAY | In distribution |
| 195580 | 12MM THICKNESS 87MM TRAY | In distribution |
| 195808 | 10MM THICKNESS 63/65/67 TRAY | In distribution |
| 195937 | 72.5 MM | In distribution |
| SSI002346 | Height 10 mm | In distribution |
| 195940 | 80 MM | In distribution |
| SSI003228 | 79/83 MM, PS/PS+/CR-L RG | In distribution |
| 195881 | 13MM THICKNESS 63/65/67 TRAY | In distribution |
| SSI002358 | Height 12 mm | In distribution |
| 195534 | 16MM THICKNESS 59MM TRAY | In distribution |
| 195814 | 9MM THICKNESS 69/71/73/75 TRAY | In distribution |
| 195567 | 13MM THICKNESS 79MM TRAY | In distribution |
| 195882 | 14MM THICKNESS 63/65/67 TRAY | In distribution |
| 195810 | 12MM THICKNESS 63/65/67 TRAY | In distribution |
| 195879 | 11MM THICKNESS 63/65/67 TRAY | In distribution |
| SSI004321 | Size 31 | In distribution |
| 195850 | 10MM THICKNESS 69/71/73/75 TRAY | In distribution |
| 195286 | 73 MM | In distribution |
| 195612 | 9MM THICKNESS 69/71 TRAY | In distribution |
| 195551 | 11MM THICKNESS 69/71 TRAY | In distribution |
| 195535 | 9MM THICKNESS 63MM TRAY | In distribution |
| SSI002372 | Height 12 mm | In distribution |
| 195762 | 59/63 MM 65/67 MM | In distribution |
| 195900 | 11MM THICKNESS 87/91 TRAY | 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 |
|---|---|
| K080528 | 2008-06-17 |
| K022586 | 2002-08-15 |
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.