Vanguard XP® Instrumentation
130 catalogue numbers from 32-700338, listed by Biomet Orthopedics, United States, under Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
130catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Jiangsu (2), Zhejiang (1). 2 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 |
| 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 |
Record
| Listed by | Biomet Orthopedics, United States |
|---|---|
| FDA product code | MBV |
| Device type | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3560 |
| 510(k) | K122160 |
| Record published | 2021-04-02 |
| Record revised | 2025-05-30 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 32-700338 | 10 mm X 91 mm | In distribution |
| 32-700398 | 60 mm | In distribution |
| 32-700279 | 14MM X 91MM | In distribution |
| 32-700395 | 52.5 mm | In distribution |
| 32-700082 | 13 mm 59 mm | In distribution |
| 32-700148 | 9 mm X 59 mm | In distribution |
| 32-700182 | 16 mm X 87/91 mm | In distribution |
| 32-700133 | 16 mm X 69/71/73/75 mm | In distribution |
| 32-700087 | 11MM X 63/65/67MM | In distribution |
| 32-700264 | 13MM X 83MM | In distribution |
| 32-700068 | 87-91 mm | In distribution |
| 32-700181 | 14MM X 87/91MM | In distribution |
| 32-700067 | 69 – 83MM | In distribution |
| 32-700278 | 13MM X 91MM | In distribution |
| 32-700079 | 10 mm 59 mm | In distribution |
| 32-700272 | 14MM X 87MM | In distribution |
| 32-700273 | 16 mm X 87 mm | In distribution |
| 32-700140 | 16 mm X 79/83 mm | In distribution |
| 32-700296 | 10 mm X 65/67 mm | In distribution |
| 32-700031 | 75MM LEFT | In distribution |
| 32-700147 | 16 mm X 87/91 mm | In distribution |
| 32-700096 | 13 mm X 69/71/73/75 mm | In distribution |
| 32-700206 | 11 mm X 79/83 mm | In distribution |
| 32-700330 | 9MM X 87MM | In distribution |
| 32-700313 | 13MM X 73/75MM | In distribution |
| 32-700107 | 10 mm X 87/91 mm | In distribution |
| 32-700329 | 16 mm X 83 mm | In distribution |
| 32-700124 | 13MM X 63/65/67MM | In distribution |
| 32-700108 | 11 mm X 87/91 mm | In distribution |
| 32-700038 | In distribution | |
| 32-700095 | 12 mm X 69/71/73/75 mm | In distribution |
| 32-700234 | 11 mm X 65/67 mm | In distribution |
| 32-700257 | 13 mm X 79 mm | In distribution |
| 32-700062 | 79MM TIBIAL TRAY TRIAL | In distribution |
| 32-700094 | 11 mm X 69/71/73/75 mm | In distribution |
| 32-700065 | 91 mm | In distribution |
| 32-700247 | 10 mm X 73/75 mm | In distribution |
| 32-700333 | 12 mm X 87 mm | In distribution |
| 32-700209 | 14MM X 79/83MM | In distribution |
| 32-700335 | 14 mm X 87 mm | In distribution |
| 32-700213 | 11MM X 87/91MM | In distribution |
| 32-700089 | 13 mm X 63/65/67 mm | In distribution |
| 32-700176 | 9 mm X 87/91 mm | In distribution |
| 32-700181 | 14 mm X 87/91 mm | In distribution |
| 32-700086 | 10MM X 63/65/67MM | In distribution |
| 32-700197 | 9 mm X 69/71/73/75 mm | In distribution |
| 32-700300 | 14MM X 65/67MM | In distribution |
| 32-700325 | 11 mm X 83 mm | In distribution |
| 32-700083 | 14 mm 59 mm | In distribution |
| 32-700174 | 14 mm X 79/83 mm | In distribution |
| 32-700176 | 9MM X 87/91MM | In distribution |
| 32-700259 | 16MM X 79MM | In distribution |
| 32-700072 | In distribution | |
| 32-700122 | 11 mm X 63/65/67 mm | In distribution |
| 32-700304 | 11 mm X 69/71 mm | In distribution |
| 32-700284 | 12 mm X 59 mm | In distribution |
| 32-700213 | 11 mm X 87/91 mm | In distribution |
| 32-700312 | 12 mm X 73/75 mm | In distribution |
| 32-700215 | 13MM X 87/91MM | In distribution |
| 32-700335 | 14MM X 87MM | In distribution |
| 32-700172 | 12 mm X 79/83 mm | In distribution |
| 32-700247 | 10MM X 73/75MM | In distribution |
| 32-700275 | 10 mm X 91 mm | In distribution |
| 32-700109 | 12MM X 87/91MM | In distribution |
| 32-700110 | 13MM X 87/91MM | In distribution |
| 32-700313 | 13 mm X 73/75 mm | In distribution |
| 32-700290 | 11MM X 63MM | In distribution |
| 32-700014 | 60MM RIGHT | In distribution |
| 32-700161 | 16MM X 63 / 65 / 67MM | In distribution |
| 32-700064 | 87MM TIBIAL TRAY TRIAL | In distribution |
| 32-700204 | 9 mm X 79/83 mm | In distribution |
| 32-700236 | 13 mm X 65/67 mm | In distribution |
| 32-700124 | 13 mm X 63/65/67 mm | In distribution |
| 32-700100 | 10MM X 79/83MM | In distribution |
| 32-700171 | 11 mm X 79/83 mm | In distribution |
| 32-700075 | In distribution | |
| 32-700081 | 12 mm 59 mm | In distribution |
| 32-700339 | 11MM X 91MM | In distribution |
| 32-700231 | 16 mm X 63 mm | In distribution |
| 32-700200 | 12 mm X 69/71/73/75 mm | In distribution |
| 32-700134 | 9MM X 79/83MM | In distribution |
| 32-700281 | 9 mm X 59 mm | In distribution |
| 32-700230 | 14MM X 63MM | In distribution |
| 32-700012 | 55MM RIGHT | In distribution |
| 32-700189 | 16 mm X 59 mm | In distribution |
| 32-700191 | 10 mm X 63/65/67 mm | In distribution |
| 32-700417 | 77.5 mm | In distribution |
| 32-700340 | 12 mm X 91 mm | In distribution |
| 32-700302 | 9 mm X 69/71 mm | In distribution |
| 32-700317 | 10 mm X 79 mm | In distribution |
| 32-700076 | In distribution | |
| 32-700222 | 13 mm X 59 mm | In distribution |
| 32-700180 | 13 mm X 87/91 mm | In distribution |
| 32-700269 | 11MM X 87MM | In distribution |
| 32-700139 | 14 mm X 79/83 mm | In distribution |
| 32-700080 | 11 mm 59 mm | In distribution |
| 32-700160 | 14 mm X 63/65/67 mm | In distribution |
| 32-700055 | 63 mm | In distribution |
| 32-700391 | In distribution | |
| 32-700023 | 55MM LEFT | In distribution |
| 32-700241 | 11 mm X 69/71 mm | In distribution |
| 32-700230 | 14 mm X 63 mm | In distribution |
| 32-700333 | 12MM X 87MM | In distribution |
| 32-700321 | 14 mm X 79 mm | In distribution |
| 32-700316 | 9 mm X 79 mm | In distribution |
| 32-700144 | 12 mm X 87/91 mm | In distribution |
| 32-700256 | 12 mm X 79 mm | In distribution |
| 32-700403 | 72.5MM, RIGHT | In distribution |
| 32-700253 | 9MM X 79MM | In distribution |
| 32-700338 | 10MM X 91MM | In distribution |
| 32-700328 | 14MM X 83MM | In distribution |
| 32-700155 | 9 mm X 63/65/67 mm | In distribution |
| 32-700056 | 65MM TIBIAL TRAY TRIAL | In distribution |
| 32-700263 | 12 mm X 83 mm | In distribution |
| 32-700188 | 14 mm X 59 mm | In distribution |
| 32-700128 | 10 mm X 69/71/73/75 mm | In distribution |
| 32-700268 | 10MM X 87MM | In distribution |
| 32-700266 | 16MM X 83MM | In distribution |
| 32-700235 | 12MM X 65/67MM | In distribution |
| 32-700170 | 10 mm X 79/83 mm | In distribution |
| 32-700061 | 75 mm | In distribution |
| 32-700223 | 14 mm X 59 mm | In distribution |
| 32-700312 | 12MM X 73/75MM | In distribution |
| 32-700287 | 16 mm X 59 mm | In distribution |
| 32-700402 | 70 mm | In distribution |
| 32-700143 | 11 mm X 87/91 mm | In distribution |
| 32-700134 | 9 mm X 79/83 mm | In distribution |
| 32-700112 | 16 mm X 87/91 mm | In distribution |
| 32-700404 | 75 mm | In distribution |
| 32-700175 | 16 mm X 79/83 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Vanguard Complete Knee System | Biomet Orthopedics | 106 |
| Vanguard® 360 Instrument | Biomet Orthopedics | 98 |
| Biomet® Knee System | Biomet Orthopedics | 94 |
| Maxim Knee System | Biomet Orthopedics | 73 |
| Vanguard Knee System | Biomet Orthopedics | 49 |
| Vanguard Instrument | Biomet Orthopedics | 44 |
| Vanguard 360 Revision System | Biomet Orthopedics | 43 |
| Biomet® 360 | Biomet Orthopedics | 39 |
| Biomet® 360 Instrument | Biomet Orthopedics | 36 |
| Vanguard 360 | Biomet Orthopedics | 30 |
| Biomet 360 Knee System | Biomet Orthopedics | 27 |
| Vanguard® SSK 360 Knee System | Biomet Orthopedics | 19 |
Showing 12 of 41. All products under Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer
Recalls Naming This Product
13 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 | 45 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 | 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 | 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.