Vanguard® Knee System
86 catalogue numbers from 184706, listed by Biomet Orthopedics, United States, under Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer. 10 manufacturers in China are registered for this product code.
10manufacturers in China registered for this device type
86catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (2), Zhejiang (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| 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 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| 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 |
| Suzhou Microport Orthorecon Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 31 |
Record
| Listed by | Biomet Orthopedics, United States |
|---|---|
| FDA product code | HRY |
| Device type | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3530 |
| 510(k) | K040770 |
| Record published | 2019-10-11 |
| 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 |
|---|---|---|
| 184706 | 34 mm 8.5 mm | In distribution |
| EP-183626 | 16 MM 63/67 MM | In distribution |
| 183621 | 11 mm 63/67 mm | In distribution |
| EP-183424 | 14 MM 63/67 MM | In distribution |
| EP-189108 | 18 MM 79 MM | In distribution |
| EP-183668 | 18 MM 79/83 MM | In distribution |
| CP113580 | 10 MM 87 MM | In distribution |
| EP-183584 | 14 MM 87/91 MM | In distribution |
| EP-183742 | 12 MM 71/75 MM | In distribution |
| EP-189086 | 16 MM 75 MM | In distribution |
| CP113647 | 75 MM | In distribution |
| EP-183606 | 16 MM 59 MM | In distribution |
| EP-183528 | 18 MM 63/67 MM | In distribution |
| EP-183544 | 14 MM 71/75 MM | In distribution |
| 184784 | 31 mm 6.2 mm | In distribution |
| EP-184790 | 25 MM 8 MM | In distribution |
| EP-189146 | 16 MM 87 MM | In distribution |
| EP-183501 | 11 MM 59 MM | In distribution |
| 189224 | 14 MM 63 MM | In distribution |
| EP-183622 | 12 MM 63/67 MM | In distribution |
| 189104 | 14 MM 79 MM | In distribution |
| EP-183768 | 18 MM 79/83 MM | In distribution |
| EP-183443 | 13 MM 71/75 MM | In distribution |
| EP-189062 | 12 MM 71 MM | In distribution |
| EP-189122 | 12 MM 83 MM | In distribution |
| EP-184784 | 31 MM 6.2 MM | In distribution |
| EP-183566 | 16 MM 79/83 MM | In distribution |
| EP-183508 | 18 MM 59 MM | In distribution |
| EP-183560 | 10 MM 79/83 MM | In distribution |
| EP-189124 | 14 MM 83 MM | In distribution |
| 189122 | 12 MM 83 MM | In distribution |
| EP-183446 | 16 MM 71/75 MM | In distribution |
| EP-189104 | 14 MM 79 MM | In distribution |
| EP-189064 | 14 MM 71 MM | In distribution |
| 184792 | 31 mm 8 mm | In distribution |
| EP-183520 | 10 MM 63/67 MM | In distribution |
| EP-183402 | 12 MM 59 MM | In distribution |
| EP-189026 | 16 MM 63 MM | In distribution |
| 184722 | 28 mm 6.2 mm | In distribution |
| EP-189126 | 16 MM 83 MM | In distribution |
| CP113590 | 14 MM 91 MM | In distribution |
| EP-183748 | 18 MM 71/75 MM | In distribution |
| EP-184780 | 25 MM 6.2 MM | In distribution |
| EP-184766 | 34 MM 8.5 MM | In distribution |
| EP-189066 | 16 MM 71 MM | In distribution |
| 189264 | 14 MM 71 MM | In distribution |
| EP-183583 | 13 MM 87/91 MM | In distribution |
| CP113644 | 72.5 MM | In distribution |
| EP-183482 | 12 MM 87/91 MM | In distribution |
| EP-189046 | 16 MM 67 MM | In distribution |
| 189702 | 12 MM 79 MM | In distribution |
| EP-189106 | 16 MM 79 MM | In distribution |
| 189522 | 12 MM 83 MM | In distribution |
| 189648 | 18 MM 67 MM | In distribution |
| 189684 | 14 MM 75 MM | In distribution |
| EP-183664 | 14 MM 79/83 MM | In distribution |
| EP-183526 | 16 MM 63/67 MM | In distribution |
| 189268 | 18 MM 71 MM | In distribution |
| EP-183624 | 14 MM 63/67 MM | In distribution |
| EP-183601 | 11 MM 59 MM | In distribution |
| 189308 | 18 MM 79 MM | In distribution |
| EP-189148 | 18 MM 87 MM | In distribution |
| EP-183682 | 12 MM 87/91 MM | In distribution |
| 189424 | 14 MM 63 MM | In distribution |
| EP-183586 | 16 MM 87/91 MM | In distribution |
| EP-183483 | 13 MM 87/91 MM | In distribution |
| EP-189063 | 13 MM 71 MM | In distribution |
| EP-183588 | 18 MM 87/91 MM | In distribution |
| 189446 | 16 MM 67 MM | In distribution |
| EP-189028 | 18 MM 63 MM | In distribution |
| EP-183640 | 10 MM 71/75 MM | In distribution |
| EP-183623 | 13 MM 63/67 MM | In distribution |
| EP-189120 | 10 MM 83 MM | In distribution |
| EP-183602 | 12 MM 59 MM | In distribution |
| EP-184788 | 37 MM 8.6 MM | In distribution |
| EP-189022 | 12 MM 63 MM | In distribution |
| EP-183421 | 11 MM 63/67 MM | In distribution |
| 189143 | 13 MM 87 MM | In distribution |
| EP-189103 | 13 MM 79 MM | In distribution |
| EP-183784 | 14 MM 87/91 MM | In distribution |
| EP-183502 | 12 MM 59 MM | In distribution |
| 184760 | 25 mm 8 mm | In distribution |
| EP-183620 | 10 MM 63/67 MM | In distribution |
| EP-183684 | 14 MM 87/91 MM | In distribution |
| 189460 | 10 MM 71 MM | In distribution |
| EP-183462 | 12 MM 79/83 MM | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Legion | Smith & Nephew, Inc. | 1,682 |
| Genesis II | Smith & Nephew, Inc. | 615 |
| Journey II | Smith & Nephew, Inc. | 581 |
| Evolution | Microport Orthopedics Inc. | 311 |
| Profix | Smith & Nephew, Inc. | 293 |
| Journey | Smith & Nephew, Inc. | 215 |
| LinkSymphoKnee | Waldemar Link GmbH & Co. KG | 201 |
| Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | Smith & Nephew, Inc. | 160 |
| JII | Smith & Nephew, Inc. | 141 |
| Physica KR | Limacorporate | 128 |
| Physica LMC | Limacorporate | 120 |
| Implant Partners | Microport Orthopedics Inc. | 119 |
Showing 12 of 160. All products under Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K020264 | 2002-02-08 |
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 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P840049 | 1988-09-30 | P.C.A.(TM) TOTAL KNEE SYSTEM | Howmedica Corp. |
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.