Vanguard® 360 Instrument
55 catalogue numbers from 32-360828, 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
55catalogue 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) | K140883 |
| Record published | 2022-04-02 |
| Record revised | 2025-05-30 (version 8) |
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 |
|---|---|---|
| 32-360828 | 80 mm X 15 mm | In distribution |
| 32-360802 | 70/72.5 mm X 10 mm | In distribution |
| 32-360782 | 60/62.5 mm X 15 mm | In distribution |
| 32-360732 | 62.5 mm | In distribution |
| 32-360000 | TYPE A, X-SMALL | In distribution |
| 32-360806 | 70/72.5 mm X 15 mm | In distribution |
| 32-360635 | 11MM X 80MM | In distribution |
| 32-360786 | 65/67.5 mm X 5 mm | In distribution |
| 32-360810 | 75 mm X 5 mm | In distribution |
| 32-360760 | 55/57.5 mm X 5 mm | In distribution |
| 32-360683 | 19 mm X 200 mm | In distribution |
| 32-360768 | 55/57.5 mm X 15 mm | In distribution |
| 32-360742 | 75 mm | In distribution |
| 32-360629 | 13 mm X 40 mm | In distribution |
| 32-360643 | 11MM X 120MM | In distribution |
| 32-360024 | LARGE | In distribution |
| 32-360627 | 11 mm X 40 mm | In distribution |
| 32-360005 | TYPE B, X-SMALL | In distribution |
| 32-360637 | 13MM X 80MM | In distribution |
| 32-360776 | 60/62.5 mm X 10 mm | In distribution |
| 32-360671 | 15 mm X 200 mm | In distribution |
| 32-360792 | 65/67.5 mm X 15 mm | In distribution |
| 32-360627 | 11MM X 40MM | In distribution |
| 32-360830 | 80 mm X 15 mm | In distribution |
| 32-360808 | 75 mm X 5 mm | In distribution |
| 32-360682 | 18 mm X 200 mm | In distribution |
| 32-360655 | 15 mm X 160 mm | In distribution |
| 32-360814 | 75 mm X 10 mm | In distribution |
| 32-360774 | 60/62.5 mm X 5 mm | In distribution |
| 32-360804 | 70/72.5 mm X 15 mm | In distribution |
| 32-360762 | 55/57.5 mm X 5 mm | In distribution |
| 32-360733 | 65 mm | In distribution |
| 32-360790 | 65/67.5 mm X 10 mm | In distribution |
| 32-360653 | 13MM X 160MM | In distribution |
| 32-360770 | 55/57.5 mm X 15 mm | In distribution |
| 32-360639 | 15 mm X 80 mm | In distribution |
| 32-360784 | 65/67.5 mm X 5 mm | In distribution |
| 32-360637 | 13 mm X 80 mm | In distribution |
| 32-360007 | TYPE B, MEDIUM | In distribution |
| 32-360818 | 75 mm X 15 mm | In distribution |
| 32-360631 | 15 mm X 40 mm | In distribution |
| 32-360812 | 75 mm X 10 mm | In distribution |
| 32-360647 | 15 mm X 120 mm | In distribution |
| 32-360021 | X-SMALL | In distribution |
| 32-360669 | 13MM X 200MM | In distribution |
| 32-360744 | 80 mm | In distribution |
| 32-360766 | 55/57.5 mm X 10 mm | In distribution |
| 32-360736 | 67.5 mm | In distribution |
| 32-360022 | SMALL | In distribution |
| 32-360738 | 70 mm | In distribution |
| 32-360731 | 62.5 mm | In distribution |
| 32-360671 | 15MM X 200MM | In distribution |
| 32-360726 | 55 mm | In distribution |
| 32-360645 | 13 mm X 120 mm | In distribution |
| 32-360735 | 67.5 mm | 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 |
| Vanguard XP Instrumentation | Biomet Orthopedics | 150 |
| Truliant® | Exactech, Inc. | 142 |
Showing 12 of 948. All products under Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Recalls Naming This Product
5 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 | 2020-12-01 | Class II | Process control | Incorrect bolt -tibial bolts in package instead of femoral bolts may delay procedure | 21 units | 2022-07-08 |
| Biomet, Inc. | 510(k) number | 2018-08-02 | Class II | Under Investigation by firm | The implant only has one bolt in the sterile package but it should have had two. | 16 | 2019-04-25 |
| Biomet, Inc. | 510(k) number | 2018-08-02 | Class II | Under Investigation by firm | The implant only has one bolt in the sterile package but it should have had two. | 16 | 2019-04-25 |
| Biomet, Inc. | 510(k) number | 2016-08-08 | Class II | Process control | The drill bit used to drill the hex pre-drilled hole in the screw head of the Tibial Augment Bolts included in the Vanguard 360 Revision Knee System was larger than allowable per the process specification. As a result, the hex geometry can | 454 | 2017-06-05 |
| Biomet, Inc. | 510(k) number | 2014-07-01 | Class II | Process change control | The Vanguard 360 Femoral Boss Reamers were manufactured oversized to the print. The instrument may not fit into the mating component. | 461 | 2015-10-30 |
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.