Vanguard XP® Complete Knee System
13 catalogue numbers from 195754, 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
13catalogue 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 | 2025-12-23 |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 195754 | 69 MM | In distribution |
| 195914 | 75 MM | In distribution |
| 195750 | 59 MM | In distribution |
| 195907 | 57.5 MM | In distribution |
| 195912 | 70 MM | In distribution |
| 195757 | 75 MM | In distribution |
| 195764 | 79/83 MM 87/91 MM | In distribution |
| 195909 | 62.5 MM | In distribution |
| 195922 | 65 MM | In distribution |
| 195763 | 69/71 MM 73/75 MM | In distribution |
| 195752 | 65 MM | In distribution |
| 195920 | 60 MM | In distribution |
| 195924 | 70 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
23 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 | 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 | 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 | 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.