Vanguard XP Instrumentation
150 catalogue numbers from 32-700252, listed by Biomet Orthopedics, United States, under Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer. 12 manufacturers in China are registered for this product code.
12manufacturers in China registered for this device type
150catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (3), Zhejiang (2). 8 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 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| 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 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Biomet Orthopedics, United States |
|---|---|
| FDA product code | MBH |
| Device type | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3565 |
| 510(k) | K122160 |
| Record published | 2016-10-21 |
| 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 |
|---|---|---|
| 32-700252 | 16MM X 73/75MM | In distribution |
| 32-700307 | 14MM X 69/71MM | In distribution |
| 32-700232 | 9 mm X 65/67 mm | In distribution |
| 32-700396 | 55MM, RIGHT | In distribution |
| 32-700291 | 12MM X 63MM | In distribution |
| 32-700416 | 75 mm | In distribution |
| 32-700316 | 9MM X 79MM | In distribution |
| 32-700229 | 13 mm X 63 mm | In distribution |
| 32-700178 | 11MM X 87/91MM | In distribution |
| 32-700063 | 83MM TIBIAL TRAY TRIAL | In distribution |
| 32-700245 | 16MM X 69/71MM | In distribution |
| 32-700320 | 13MM X 79MM | In distribution |
| 32-700332 | 11MM X 87MM | In distribution |
| 32-700027 | 65MM LEFT | In distribution |
| 32-700279 | 14 mm X 91 mm | In distribution |
| 32-700201 | 13 mm X 69/71/73/75 mm | In distribution |
| 32-700135 | 10MM X 79/83MM | In distribution |
| 32-700055 | 63MM TIBIAL TRAY TRIAL | In distribution |
| 32-700169 | 9 mm X 79/83 mm | In distribution |
| 32-700116 | 12 mm 59 mm | In distribution |
| 32-700141 | 9 mm X 87/91 mm | In distribution |
| 32-700238 | 16MM X 65/67MM | In distribution |
| 32-700140 | 16MM X 79 / 83MM | In distribution |
| 32-700117 | 13 mm 59 mm | In distribution |
| 32-700129 | 11 mm X 69/71/73/75 mm | In distribution |
| 32-700393 | 77.5MM / RIGHT | In distribution |
| 32-700061 | 75MM TIBIAL TRAY TRIAL | In distribution |
| 32-700106 | 9 mm X 87/91 mm | In distribution |
| 32-700305 | 12 mm X 69/71 mm | In distribution |
| 32-700276 | 11 mm X 91 mm | In distribution |
| 32-700297 | 11MM X 65/67MM | In distribution |
| 32-700412 | 65 mm | In distribution |
| 32-700253 | 9 mm X 79 mm | In distribution |
| 32-700309 | 9MM X 73/75MM | In distribution |
| 32-700265 | 14MM X 83MM | In distribution |
| 32-700404 | 75MM, RIGHT | In distribution |
| 32-700296 | 10MM X 65/67MM | In distribution |
| 32-700142 | 10MM X 87/91MM | In distribution |
| 32-700168 | 16MM X 69 / 71 / 73 / 75MM | In distribution |
| 32-700071 | 87 – 91MM | In distribution |
| 32-700178 | 11 mm X 87/91 mm | In distribution |
| 32-700064 | 87 mm | In distribution |
| 32-700324 | 10MM X 83MM | In distribution |
| 32-700066 | 59 – 67 MM | In distribution |
| 32-700088 | 12MM X 63/65/67MM | In distribution |
| 32-700034 | Size 63-83 | In distribution |
| 32-700254 | 10MM X 79MM | In distribution |
| 32-700319 | 12 mm X 79 mm | In distribution |
| 32-700089 | 13MM X 63/65/67MM | In distribution |
| 32-700251 | 14 mm X 73/75 mm | In distribution |
| 32-700146 | 14MM X 87/91MM | In distribution |
| 32-700120 | 9 mm X 63/65/67 mm | In distribution |
| 32-700062 | 79 mm | In distribution |
| 32-700240 | 10 mm X 69/71 mm | In distribution |
| 32-700384 | Sizes 63 mm – 83 mm | In distribution |
| 32-700262 | 11MM X 83MM | In distribution |
| 32-700387 | SIZES 63-83 | In distribution |
| 32-700304 | 11MM X 69/71MM | In distribution |
| 32-700017 | 67.5MM RIGHT | In distribution |
| 32-700246 | 9MM X 73/75MM | In distribution |
| 32-700254 | 10 mm X 79 mm | In distribution |
| 32-700301 | 16MM X 65/67MM | In distribution |
| 32-700256 | 12MM X 79MM | In distribution |
| 32-700336 | 16MM X 87MM | In distribution |
| 32-700021 | 80MM RIGHT | In distribution |
| 32-700406 | 80MM, RIGHT | In distribution |
| 32-700275 | 10MM X 91MM | In distribution |
| 32-700147 | 16MM X 87/91MM | In distribution |
| 32-700239 | 9MM X 69/71MM | In distribution |
| 32-700132 | 14MM X 69/71/73/75MM | In distribution |
| 32-700308 | 16 mm X 69/71 mm | In distribution |
| 32-700259 | 16 mm X 79 mm | In distribution |
| 32-700264 | 13 mm X 83 mm | In distribution |
| 32-700231 | 16MM X 63MM | In distribution |
| 32-700065 | 91MM TIBIAL TRAY TRIAL | In distribution |
| 32-700411 | 62.5MM, LEFT | In distribution |
| 32-700292 | 13 mm X 63 mm | In distribution |
| 32-700394 | 77.5MM / LEFT | In distribution |
| 32-700255 | 11 mm X 79 mm | In distribution |
| 32-700257 | 13MM X 79MM | In distribution |
| 32-700196 | 16 mm X 63/65/67 mm | In distribution |
| 32-700294 | 16MM X 63MM | In distribution |
| 32-700211 | 9 mm X 87/91 mm | In distribution |
| 32-700123 | 12MM X 63/65/67MM | In distribution |
| 32-700177 | 10MM X 87/91MM | In distribution |
| 32-700265 | 14 mm X 83 mm | In distribution |
| 32-700105 | 16MM X 79/83MM | In distribution |
| 32-700278 | 13 mm X 91 mm | In distribution |
| 32-700187 | 13 mm X 59 mm | In distribution |
| 32-700177 | 10 mm X 87/91 mm | In distribution |
| 32-700262 | 11 mm X 83 mm | In distribution |
| 32-700267 | 9 mm X 87 mm | In distribution |
| 32-700183 | 9 mm X 59 mm | In distribution |
| 32-700395 | 52.5MM, RIGHT | In distribution |
| 32-700305 | 12MM X 69/71MM | In distribution |
| 32-700170 | 10MM X 79/83MM | In distribution |
| 32-700292 | 13MM X 63MM | In distribution |
| 32-700121 | 10MM X 63/65/67MM | In distribution |
| 32-700030 | 72.5MM LEFT | In distribution |
| 32-700225 | 9MM X 63MM | In distribution |
| 32-700125 | 14 mm X 63/65/67 mm | In distribution |
| 32-700311 | 11MM X 73/75MM | In distribution |
| 32-700199 | 11 mm X 69/71/73/75 mm | In distribution |
| 32-700337 | 9MM X 91MM | In distribution |
| 32-700056 | 65 mm | In distribution |
| 32-700034 | SIZE 63 – 83 VERTICAL TIBIAL RESECTION BLOCK | In distribution |
| 32-700402 | 70MM, RIGHT | In distribution |
| 32-700277 | 12 mm X 91 mm | In distribution |
| 32-700205 | 10 mm X 79/83 mm | In distribution |
| 32-700268 | 10 mm X 87 mm | In distribution |
| 32-700226 | 10MM X 63MM | In distribution |
| 32-700290 | 11 mm X 63 mm | In distribution |
| 32-700111 | 14 mm X 87/91 mm | In distribution |
| 32-700233 | 10MM X 65/67MM | In distribution |
| 32-700101 | 11MM X 79/83MM | In distribution |
| 32-700343 | 16MM X 91MM | In distribution |
| 32-700207 | 12 mm X 79/83 mm | In distribution |
| 32-700217 | 16 mm X 87/91 mm | In distribution |
| 32-700028 | 67.5MM LEFT | In distribution |
| 32-700244 | 14 mm X 69/71 mm | In distribution |
| 32-700130 | 12MM X 69/71/73/75MM | In distribution |
| 32-700276 | 11MM X 91MM | In distribution |
| 32-700216 | 14 mm X 87/91 mm | In distribution |
| 32-700329 | 16MM X 83MM | In distribution |
| 32-700151 | 12 mm X 59 mm | In distribution |
| 32-700396 | 55 mm | In distribution |
| 32-700121 | 10 mm X 63/65/67 mm | In distribution |
| 32-700190 | 9 mm X 63/65/67 mm | In distribution |
| 32-700015 | 62.5MM RIGHT | In distribution |
| 32-700288 | 9MM X 63MM | In distribution |
| 32-700341 | 13 mm X 91 mm | In distribution |
| 32-700138 | 13 mm X 79/83 mm | In distribution |
| 32-700299 | 13MM X 65/67MM | In distribution |
| 32-700227 | 11 mm X 63 mm | In distribution |
| 32-700210 | 16MM X 79/83MM | In distribution |
| 32-700343 | 16 mm X 91 mm | In distribution |
| 32-700013 | 57.5MM RIGHT | In distribution |
| 32-700415 | 72.5 mm | In distribution |
| 32-700102 | 12 mm X 79/83 mm | In distribution |
| 32-700130 | 12 mm X 69/71/73/75 mm | In distribution |
| 32-700193 | 12 mm X 63/65/67 mm | In distribution |
| 32-700145 | 13MM X 87/91MM | In distribution |
| 32-700224 | 16 mm X 59 mm | In distribution |
| 32-700295 | 9MM X 65/67MM | In distribution |
| 32-700243 | 13MM X 69/71MM | In distribution |
| 32-700132 | 14 mm X 69/71/73/75 mm | In distribution |
| 32-700018 | 70MM RIGHT | In distribution |
| 32-700144 | 12MM X 87/91MM | In distribution |
| 32-700115 | 11 mm 59 mm | In distribution |
| 32-700029 | 70MM LEFT | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Prophecy | Microport Orthopedics Inc. | 4,272 |
| Triathlon | Howmedica Osteonics Corp | 712 |
| Instrument | Howmedica Osteonics Corp | 709 |
| Persona® Vivacit-E® | Zimmer, Inc. | 499 |
| Arthrex® | Arthrex, Inc. | 494 |
| Persona® | Zimmer, Inc. | 441 |
| Legion | Smith & Nephew, Inc. | 397 |
| U2 Total Knee System | United Orthopedic Corp. | 286 |
| Attune | Depuy (Ireland) | 234 |
| DJO Surgical | Encore Medical, L.P. | 191 |
| Truliant® | Exactech, Inc. | 142 |
| Vanguard Knee System | Biomet Orthopedics | 125 |
Showing 12 of 948. All products under Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, 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.