Mobio™ Total Knee System
PS+ Tibial Insert, Size HJ/7-10+, 16mm thickness, Vitamin E UHMWPE
8manufacturers in China registered for this device type
95catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (4), Shanghai (2), Zhejiang (1). 3 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 |
| b-ONE Medical (Beijing) Co., Ltd. | Beijing | Beijing | Contract manufacturer | 7 |
| 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 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | B-ONE Ortho, Corp., United States |
|---|---|
| FDA product code | OIY |
| Device type | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3560 |
| Establishment | Specification developer, Manufacturer |
| Record published | 2019-05-13 |
| Record revised | 2021-02-05 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8821343509 | In distribution | |
| 8821323709 | In distribution | |
| 8821333025 | In distribution | |
| 8821333110 | In distribution | |
| 8821333113 | In distribution | |
| 8821343009 | In distribution | |
| 8821343109 | In distribution | |
| 8821333325 | In distribution | |
| 8821343022 | In distribution | |
| 8821343013 | In distribution | |
| 8821343011 | In distribution | |
| 8821333509 | In distribution | |
| 8821343310 | In distribution | |
| 8821343122 | In distribution | |
| 8821343511 | In distribution | |
| 8821333725 | In distribution | |
| 8821343716 | In distribution | |
| 8821343010 | In distribution | |
| 8821343513 | In distribution | |
| 8821333019 | In distribution | |
| 8821333510 | In distribution | |
| 8821333122 | In distribution | |
| 8821413207 | In distribution | |
| 8821333716 | In distribution | |
| 8821343725 | In distribution | |
| 8821343809 | In distribution | |
| 8821343025 | In distribution | |
| 8821343322 | In distribution | |
| 8821333022 | In distribution | |
| 8821343811 | In distribution | |
| 8821413408 | In distribution | |
| 8821343519 | In distribution | |
| 8821343019 | In distribution | |
| 8821333516 | In distribution | |
| 8821343125 | In distribution | |
| 8821333710 | In distribution | |
| 8821333709 | In distribution | |
| 8821333111 | In distribution | |
| 8821343119 | In distribution | |
| 8821343510 | In distribution | |
| 8821343313 | In distribution | |
| 8821343711 | In distribution | |
| 8821343825 | In distribution | |
| 8821413609 | In distribution | |
| 8821333311 | In distribution | |
| 8821333010 | In distribution | |
| 8821343316 | In distribution | |
| 8821343522 | In distribution | |
| 8821343810 | In distribution | |
| 8821333711 | In distribution | |
| 8821333719 | In distribution | |
| 8821333519 | In distribution | |
| 8821343116 | In distribution | |
| 8821413509 | In distribution | |
| 8821333116 | In distribution | |
| 8821333525 | In distribution | |
| 8821333722 | In distribution | |
| 8821343525 | In distribution | |
| 8821333125 | In distribution | |
| 8821333011 | In distribution | |
| 8821343309 | In distribution | |
| 8821333013 | In distribution | |
| 8821343813 | In distribution | |
| 8821333016 | In distribution | |
| 8821343016 | In distribution | |
| 8821333309 | In distribution | |
| 8821343516 | In distribution | |
| 8821343822 | In distribution | |
| 8821343709 | In distribution | |
| 8821333009 | In distribution | |
| 8821343722 | In distribution | |
| 8821413710 | In distribution | |
| 8821333310 | In distribution | |
| 8821333522 | In distribution | |
| 8821343816 | In distribution | |
| 8821333316 | In distribution | |
| 8821343319 | In distribution | |
| 8821333319 | In distribution | |
| 8821333511 | In distribution | |
| 8821343111 | In distribution | |
| 8821333513 | In distribution | |
| 8821343113 | In distribution | |
| 8821333713 | In distribution | |
| 8821313719 | In distribution | |
| 8821333119 | In distribution | |
| 8821333322 | In distribution | |
| 8821343710 | In distribution | |
| 8821343311 | In distribution | |
| 8821333109 | In distribution | |
| 8821343719 | In distribution | |
| 8821343819 | In distribution | |
| 8821343110 | In distribution | |
| 8821343713 | In distribution | |
| 8821343325 | In distribution | |
| 8821333313 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Persona® | Zimmer, Inc. | 552 |
| DJO Surgical | Encore Medical, L.P. | 415 |
| Genflex2 Total Knee System | Globus Medical, Inc. | 389 |
| Persona® Vivacit-E® | Zimmer, Inc. | 332 |
| Truliant, Activit-E | Exactech, Inc. | 272 |
| TriVerse Meniscal Insert PS | Signature Orthopaedics PTY Limited | 220 |
| U2™ Knee | United Orthopedic Corp. | 195 |
| BKS E-Vitalize | Ortho Development Corp. | 193 |
| Vanguard XP Instrumentation | Biomet Orthopedics | 169 |
| Attune | Depuy (Ireland) | 161 |
| Vanguard Complete Knee System | Biomet Orthopedics | 153 |
| EXp Tibial Inserts and Patellar Components | Globus Medical, Inc. | 144 |
Showing 12 of 102. All products under Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
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.