Vanguard Knee System
99 catalogue numbers from 189440, 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
99catalogue 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) | K060525 |
| Record published | 2015-10-24 |
| Record revised | 2025-05-30 (version 10) |
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 |
|---|---|---|
| 189440 | 10 MM 67 MM | In distribution |
| 189462 | 12 MM 71 MM | In distribution |
| CP113620 | 67.5 MM | In distribution |
| EP-183648 | 18 MM 71/75 MM | In distribution |
| EP-183463 | 13 MM 79/83 MM | In distribution |
| EP-183764 | 14 MM 79/83 MM | In distribution |
| EP-183780 | 10 MM 87/91 MM | In distribution |
| EP-183504 | 14 MM 59 MM | In distribution |
| 189003 | 13 MM 59 MM | In distribution |
| 189124 | 14 MM 83 MM | In distribution |
| CP113639 | 65 MM | In distribution |
| CP113614 | 60 MM | In distribution |
| EP-183542 | 12 MM 71/75 MM | In distribution |
| 184794 | 37 mm 10 mm | In distribution |
| 184790 | 25 mm 8 mm | In distribution |
| EP-183546 | 16 MM 71/75 MM | In distribution |
| 189504 | 14 MM 79 MM | In distribution |
| EP-183423 | 13 MM 63/67 MM | In distribution |
| EP-183444 | 14 MM 71/75 MM | In distribution |
| 184766 | 34 mm 8.5 mm | In distribution |
| CP113616 | 62.5 MM | In distribution |
| 189144 | 14 MM 87 MM | In distribution |
| 183683 | 13 MM 87/91 MM | In distribution |
| 189624 | 14 MM 63 MM | In distribution |
| EP-189003 | 13 MM 59 MM | In distribution |
| EP-189102 | 12 MM 79 MM | In distribution |
| 189021 | 11 MM 63 MM | In distribution |
| 183128 | 65 mm Left | In distribution |
| CP113642 | 70 MM | In distribution |
| 183603 | 13 MM 59 MM | In distribution |
| 189041 | 11 MM 67 MM | In distribution |
| EP-183766 | 16 MM 79/83 MM | In distribution |
| EP-189084 | 14 MM 75 MM | In distribution |
| 183583 | 13 MM 87/91 MM | In distribution |
| EP-184794 | 37 MM 10 MM | In distribution |
| EP-183644 | 14 MM 71/75 MM | In distribution |
| EP-183782 | 12 MM 87/91 MM | In distribution |
| EP-183726 | 16 MM 63/67 MM | In distribution |
| 184710 | 40 mm 10 mm | In distribution |
| 189103 | 13 MM 79 MM | In distribution |
| EP-183704 | 14 MM 59 MM | In distribution |
| EP-183461 | 11 MM 79/83 MM | In distribution |
| EP-189068 | 18 MM 71 MM | In distribution |
| 183621 | 11 MM 63/37 MM | In distribution |
| EP-183543 | 13 MM 71/75 MM | In distribution |
| EP-183404 | 14 MM 59 MM | In distribution |
| 189724 | 14 MM 83 MM | In distribution |
| 189620 | 10 MM 63 MM | In distribution |
| 184788 | 37 mm 8.6 mm | In distribution |
| 183401 | 11 MM 59 MM | In distribution |
| 184780 | 25 mm 6.2 mm | In distribution |
| EP-183600 | 10 MM 59 MM | In distribution |
| 183641 | 11 MM 71/75 MM | In distribution |
| EP-184793 | 34 MM 8.5 MM | In distribution |
| 183523 | 13 MM 63/67 MM | In distribution |
| EP-183702 | 12 MM 59 MM | In distribution |
| 189141 | 11 MM 87 MM | In distribution |
| 184793 | 34 mm 8.5 mm | In distribution |
| 183623 | 13 MM 63/67 MM | In distribution |
| 189488 | 18 MM 75 MM | In distribution |
| EP-183401 | 11 MM 59 MM | In distribution |
| 184795 | 40 mm 10 mm | In distribution |
| 183661 | 11 MM 79/83 MM | In distribution |
| EP-183503 | 13 MM 59 MM | In distribution |
| EP-183604 | 14 MM 59 MM | In distribution |
| 184702 | 28 mm 8 mm | In distribution |
| EP-183486 | 16 MM 87/91 MM | In distribution |
| 184764 | 31 mm 8 mm | In distribution |
| EP-183422 | 12 MM 63/67 MM | In distribution |
| EP-183440 | 10 MM 71/75 MM | In distribution |
| 184724 | 31 mm 6.2 mm | In distribution |
| CP113588 | 10 MM 91 MM | In distribution |
| EP-189142 | 12 MM 87 MM | In distribution |
| CP113636 | 62.5 MM | In distribution |
| EP-183484 | 14 MM 87/91 MM | In distribution |
| EP-183643 | 13 MM 71/75 MM | In distribution |
| EP-189006 | 16 MM 59 MM | In distribution |
| 183601 | 11 MM 59 MM | In distribution |
| 184726 | 34 mm 7.8 mm | In distribution |
| 189043 | 13 MM 67 MM | In distribution |
| CP113581 | 12 MM 87 MM | In distribution |
| 189023 | 13 MM 63 MM | In distribution |
| EP-183720 | 10 MM 63/67 MM | In distribution |
| EP-183722 | 12 MM 63/67 MM | In distribution |
| 184728 | 37 mm 8.6 mm | In distribution |
| EP-183548 | 18 MM 71/75 MM | In distribution |
| EP-189061 | 11 MM 71 MM | In distribution |
| EP-189043 | 13 MM 67 MM | In distribution |
| 189266 | 16 MM 71 MM | In distribution |
| EP-189144 | 14 MM 87 MM | In distribution |
| EP-183661 | 11 MM 79/83 MM | In distribution |
| EP-189023 | 13 MM 63 MM | In distribution |
| 189288 | 18 MM 75 MM | In distribution |
| 189420 | 10 MM 63 MM | In distribution |
| EP-183563 | 13 MM 79/83 MM | In distribution |
| EP-183686 | 16 MM 87/91 MM | In distribution |
| EP-183786 | 16 MM 87/91 MM | In distribution |
| EP-183441 | 11 MM 71/75 MM | In distribution |
| 183421 | 11 MM 63/67 MM | 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 |
| Vanguard Complete Knee System | Biomet Orthopedics | 153 |
| EXp Tibial Inserts and Patellar Components | Globus Medical, Inc. | 144 |
Showing 12 of 102. All products under Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
Recalls Naming This Product
36 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 | 46 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 | 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 | 93 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 | 2017-09-29 | Class II | Labeling mix-ups | Knee implant components (tibial bearings) are labeled with the incorrect size. | 24 | 2019-04-17 |
| Biomet, Inc. | 510(k) number | 2017-09-29 | Class II | Labeling mix-ups | Knee implant components (tibial bearings) are labeled with the incorrect size. | 24 | 2019-04-17 |
| 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 | 2017-01-04 | Class II | Process change control | packaging of some femoral components was incorrectly labeled as either smaller or larger and/or as the incorrect side (right/left). Risk delay in surgery. | 15,000 | 2018-06-11 |
| Biomet, Inc. | 510(k) number | 2016-08-09 | Class II | Labeling mix-ups | Contents of the package do not match the product labeling. Product is labeled: Vanguard Distal Femoral Augment 75 X 5 RL/LM Carton contains: Vanguard Distal Femoral Augment 75 X 5 LL/RM Risks: Adverse health outcomes that could occur as a r | 5 | 2017-05-17 |
| 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 | |
| Biomet, Inc. | 510(k) number | 2011-07-06 | Not classified | Employee error | The recalled device was manufactured with two distal pegs but package labeling indicates the device is pegless. | 8 | 2012-09-26 |
| Biomet, Inc. | 510(k) number | 2010-04-20 | Not classified | Process control | A knee implant labeled as left was opened and the package actually contained a right knee implant. | 5 | 2011-01-19 |
| Biomet, Inc. | 510(k) number | 2008-02-12 | Not classified | Packaging process control | Mislabeled: The packaging of the two products was mixed up, resulting in the products being labeled with an incorrect size. If implanted, the product may not fit properly, which could require repeat surgery. The problem could also result i | 4 | 2009-12-22 |
| Biomet, Inc. | 510(k) number | 2008-02-12 | Not classified | Packaging process control | Mislabeled: The packaging of the two products was mixed up, resulting in the products being labeled with an incorrect size. If implanted, the product may not fit properly, which could require repeat surgery. The problem could also result i | 8 | 2009-12-22 |
| Biomet, Inc. | 510(k) number | 2007-08-31 | Not classified | Packaging process control | Mislabeled as to size; labeled as 67.5 mm, actually contains 62.5 mm size femoral component. | 16 | 2008-06-04 |
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.