MobileLink Acetabular Cup System
Shell/Insert Adapter; neutral; 0° inclination, 0 mm offset
8manufacturers in China registered for this device type
68catalogue 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 | Waldemar Link GmbH & Co. KG, 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 | Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K182321 |
| Record published | 2019-09-09 |
| Record revised | 2025-06-13 (version 4) |
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, serial number |
| Distribution end date | 2025-09-23 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 183-376/28 | In distribution | |
| 183-925/01 | In distribution | |
| 183-364/28 | In distribution | |
| 183-101/66 | In distribution | |
| 183-610/06 | In distribution | |
| 183-910/01 | In distribution | |
| 183-864/32 | In distribution | |
| 183-855/32 | In distribution | |
| 183-580/04 | In distribution | |
| 183-590/04 | In distribution | |
| 183-376/32 | In distribution | |
| 183-590/02 | In distribution | |
| 183-580/05 | In distribution | |
| 183-600/06 | In distribution | |
| 183-401/52 | In distribution | |
| 183-920/01 | In distribution | |
| 183-401/70 | In distribution | |
| 183-301/54 | In distribution | |
| 183-401/72 | In distribution | |
| 183-852/32 | In distribution | |
| 183-310/56 | In distribution | |
| 183-401/50 | In distribution | |
| 183-201/56 | In distribution | |
| 183-590/01 | In distribution | |
| 183-401/80 | In distribution | |
| 183-855/28 | In distribution | |
| 183-310/72 | In distribution | |
| 183-110/52 | In distribution | |
| 183-401/56 | In distribution | |
| 183-301/68 | In distribution | |
| 183-930/01 | In distribution | |
| 183-363/36 | In distribution | |
| 183-600/04 | In distribution | |
| 183-110/48 | In distribution | |
| 183-201/50 | In distribution | |
| 183-364/32 | In distribution | |
| 183-310/70 | In distribution | |
| 183-310/68 | In distribution | |
| 183-856/32 | In distribution | |
| 183-372/36 | In distribution | |
| 183-590/05 | In distribution | |
| 183-600/03 | In distribution | |
| 183-610/04 | In distribution | |
| 183-201/42 | In distribution | |
| 183-600/01 | In distribution | |
| 183-101/58 | In distribution | |
| 183-580/02 | In distribution | |
| 183-401/54 | In distribution | |
| 183-374/28 | In distribution | |
| 183-610/01 | In distribution | |
| 183-401/74 | In distribution | |
| 183-865/32 | In distribution | |
| 183-401/68 | In distribution | |
| 183-865/36 | In distribution | |
| 183-101/64 | In distribution | |
| 183-360/28 | In distribution | |
| 183-866/32 | In distribution | |
| 183-201/58 | In distribution | |
| 183-201/52 | In distribution | |
| 183-376/36 | In distribution | |
| 183-915/01 | In distribution | |
| 183-252/32 | Withdrawn | |
| 183-702/32 | Withdrawn | |
| 183-723/32 | Withdrawn | |
| 183-256/28 | Withdrawn | |
| 183-704/28 | Withdrawn | |
| 183-703/32 | Withdrawn | |
| 183-713/32 | 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 |
| G7 | Biomet Orthopedics | 54 |
| Vitelene® | Aesculap AG | 52 |
| 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
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Waldemar Link GmbH & Co. KG | 510(k) number | 2023-07-14 | Class II | Under Investigation by firm | Product is labeled with incorrect offset. | 8 units |
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.