Vanguard® 360 Instrument OsseoTi®
Catalogue number 32-360080, 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.
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) | K093293 |
| Record published | 2023-07-05 |
| Record revised | 2026-02-09 (version 3) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 32-360080 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Vanguard XP® Instrumentation | Biomet Orthopedics | 130 |
| 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 |
Showing 12 of 41. All products under Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, 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.