Biomet® 360 Instrument
33 catalogue numbers from 32-360127, listed by Biomet Orthopedics, United States, under Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer. 21 manufacturers in China are registered for this product code.
21manufacturers in China registered for this device type
33catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (10), Shanghai (4), Beijing (3). 13 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 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| b-ONE Medical (Beijing) Co., Ltd. | Beijing | Beijing | Contract manufacturer | 7 |
| Changzhou Wastonortho Medical Appliance Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 5 |
Showing 12 of 21. All 21 manufacturers in China registered for Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Record
| Listed by | Biomet Orthopedics, United States |
|---|---|
| FDA product code | JWH |
| Device type | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3560 |
| 510(k) | K093293 |
| Record published | 2023-07-05 |
| Record revised | 2025-05-30 (version 2) |
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 |
|---|---|---|
| 32-360127 | 5 mm X 87 mm | In distribution |
| 32-360124 | 5 mm X 75 mm | In distribution |
| 32-360206 | 83 mm | In distribution |
| 32-360253 | 15 mm X 71 mm | In distribution |
| 32-360210 | 2.5 mm | In distribution |
| 32-360208 | 91 mm | In distribution |
| 32-360247 | 15 mm X 87 mm | In distribution |
| 32-360137 | 10 mm X 87 mm | In distribution |
| 32-360246 | 15 mm X 83 mm | In distribution |
| 32-360236 | 10 mm X 83 mm | In distribution |
| 32-360230 | 10 mm X 59 mm | In distribution |
| 32-360203 | 71 mm | In distribution |
| 32-360238 | 10 mm X 91 mm | In distribution |
| 32-360231 | 10 mm X 63 mm | In distribution |
| 32-360245 | 15 mm X 79 mm | In distribution |
| 32-360201 | 63 mm | In distribution |
| 32-360228 | 5 mm X 91 mm | In distribution |
| 32-360126 | 5 mm X 83 mm | In distribution |
| 32-360135 | 10 mm X 79 mm | In distribution |
| 32-360257 | 15 mm X 87 mm | In distribution |
| 32-360232 | 10 mm X 67 mm | In distribution |
| 32-360223 | 5 mm X 71 mm | In distribution |
| 32-360202 | 67 mm | In distribution |
| 32-360227 | 5 mm X 87 mm | In distribution |
| 32-360138 | 10 mm X 91 mm | In distribution |
| 32-360204 | 75 mm | In distribution |
| 32-360125 | 5 mm X 79 mm | In distribution |
| 32-360122 | 5 mm X 67 mm | In distribution |
| 32-360121 | 5 mm X 63 mm | In distribution |
| 32-360130 | 10 mm X 59 mm | In distribution |
| 32-360200 | 59 mm | In distribution |
| 32-360205 | 79 mm | In distribution |
| 32-360220 | 5 mm X 59 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Prophecy® | Microport Orthopedics Inc. | 4,423 |
| Exult Knee Replacement System | Corentec Co., Ltd. | 1,770 |
| Freedom | Maxx Orthopedics Inc. | 1,693 |
| Legion | Smith & Nephew, Inc. | 1,534 |
| MyKnee | Medacta International SA | 1,466 |
| Journey | Smith & Nephew, Inc. | 1,339 |
| Persona® | Zimmer, Inc. | 1,254 |
| DJO Surgical | Encore Medical, L.P. | 1,131 |
| U2 Total Knee System | United Orthopedic Corp. | 1,078 |
| CKS Plus | Shalby Advanced Technologies, Inc. | 1,024 |
| Lospa Modular Knee System | Corentec Co., Ltd. | 1,020 |
| Natural-Knee® | Zimmer, Inc. | 980 |
Showing 12 of 1,175. All products under Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K080528 | 2008-06-17 |
| K022586 | 2002-08-15 |
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.