Vitelene®
Vitelene Insert C 22.2MM Post.wall
8manufacturers in China registered for this device type
52catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (3), Jiangsu (3), Zhejiang (1). 4 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 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Lincotek (Wuxi) Co., Ltd. | Wuxi | Jiangsu | 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 |
| Shenzhen Fox Hunting E-commerce Co., Ltd. | Shenzhen | Guangdong | Exporter | 7 |
Record
| Listed by | Aesculap AG, Germany |
|---|---|
| FDA product code | OQG |
| Device type | Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3358 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2015-11-11 |
| Record revised | 2025-11-13 (version 5) |
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 |
| Distribution end date | 2025-01-22 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NV225E | Inner diameter (mm) : 40.000 MM | Withdrawn |
| NV316E | Inner diameter (mm) : 36.000 MM | Withdrawn |
| NV217E | Inner diameter (mm) : 36.000 MM | Withdrawn |
| NV391E | Inner diameter (mm) : 28.000 MM | Withdrawn |
| NV407E | Inner diameter (mm) : 32.000 MM | Withdrawn |
| NV307E | Inner diameter (mm) : 32.000 MM | Withdrawn |
| NV403E | Inner diameter (mm) : 32.000 MM | Withdrawn |
| NV303E | Inner diameter (mm) : 32.000 MM | Withdrawn |
| NV404E | Inner diameter (mm) : 32.000 MM | Withdrawn |
| NV401E | Inner diameter (mm) : 32.000 MM | Withdrawn |
| NV406E | Figure/Size : Fig. J | Withdrawn |
| NV302E | Inner diameter (mm) : 32.000 MM | Withdrawn |
| NV284E | Inner diameter (mm) : 22.200 MM | Withdrawn |
| NV304E | Inner diameter (mm) : 32.000 MM | Withdrawn |
| NV317E | Inner diameter (mm) : 36.000 MM | Withdrawn |
| NV190E | Inner diameter (mm) : 28.000 MM | Withdrawn |
| NV204E | Inner diameter (mm) : 32.000 MM | Withdrawn |
| NV314E | Inner diameter (mm) : 36.000 MM | Withdrawn |
| NV205E | Inner diameter (mm) : 32.000 MM | Withdrawn |
| NV183E | Inner diameter (mm) : 22.200 MM | Withdrawn |
| NV184E | Inner diameter (mm) : 22.200 MM | Withdrawn |
| NV226E | Inner diameter (mm) : 40.000 MM | Withdrawn |
| NV189E | Inner diameter (mm) : 28.000 MM | Withdrawn |
| NV382E | Inner diameter (mm) : 22.200 MM | Withdrawn |
| NV227E | Inner diameter (mm) : 40.000 MM | Withdrawn |
| NV191E | Inner diameter (mm) : 28.000 MM | Withdrawn |
| NV405E | Inner diameter (mm) : 32.000 MM | Withdrawn |
| NV289E | Inner diameter (mm) : 28.000 MM | Withdrawn |
| NV315E | Inner diameter (mm) : 36.000 MM | Withdrawn |
| NV402E | Inner diameter (mm) : 32.000 MM | Withdrawn |
| NV390E | Inner diameter (mm) : 28.000 MM | Withdrawn |
| NV282E | Inner diameter (mm) : 22.200 MM | Withdrawn |
| NV283E | Inner diameter (mm) : 22.200 MM | Withdrawn |
| NV182E | Inner diameter (mm) : 22.200 MM | Withdrawn |
| NV202E | Inner diameter (mm) : 32.000 MM | Withdrawn |
| NV290E | Inner diameter (mm) : 28.000 MM | Withdrawn |
| NV305E | Inner diameter (mm) : 32.000 MM | Withdrawn |
| NV216E | Inner diameter (mm) : 36.000 MM | Withdrawn |
| NV301E | Inner diameter (mm) : 32.000 MM | Withdrawn |
| NV206E | Inner diameter (mm) : 32.000 MM | Withdrawn |
| NV207E | Inner diameter (mm) : 32.000 MM | Withdrawn |
| NV291E | Inner diameter (mm) : 28.000 MM | Withdrawn |
| NV383E | Inner diameter (mm) : 22.200 MM | Withdrawn |
| NV384E | Inner diameter (mm) : 22.200 MM | Withdrawn |
| NV215E | Inner diameter (mm) : 36.000 MM | Withdrawn |
| NV214E | Inner diameter (mm) : 36.000 MM | Withdrawn |
| NV313E | Inner diameter (mm) : 36.000 MM | Withdrawn |
| NV306E | Inner diameter (mm) : 32.000 MM | Withdrawn |
| NV213E | Inner diameter (mm) : 36.000 MM | Withdrawn |
| NV201E | Inner diameter (mm) : 32.000 MM | Withdrawn |
| NV203E | Inner diameter (mm) : 32.000 MM | Withdrawn |
| NV389E | Inner diameter (mm) : 28.000 MM | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CS2 Acet. Cup Sys. – VitalitE | Shalby Advanced Technologies, Inc. | 169 |
| iTotal® Hip Replacement System | ConforMIS, Inc. | 131 |
| CS2 Acet. Cup Sys. – VitalitE | Consensus Orthopedics, Inc. | 124 |
| DJO Surgical | Encore Medical, L.P. | 99 |
| MobileLink Acetabular Cup System | Waldemar Link GmbH & Co. KG | 68 |
| G7 | Biomet Orthopedics | 54 |
| Conformis Hip System | ConforMIS, Inc. | 51 |
| Onvoy | Globus Medical, Inc. | 48 |
| Ringloc HIP System | Biomet Orthopedics | 35 |
| Novosource Total Hip System | Novosource, LLC | 33 |
| Prime | Microport Orthopedics Inc. | 32 |
| NovoHip Total Hip System | Novosource, LLC | 28 |
Showing 12 of 100. All products under Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
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.