Aesculap
Bipolar CUP ID28MM OD48MM Self-Centering
14manufacturers in China registered for this device type
20catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (7), Shanghai (3), Zhejiang (2). 9 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 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Xian Airfoil Technology Co., Ltd. | Xian | Shaanxi | Contract manufacturer | 8 |
| Lincotek (Wuxi) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 7 |
| b-ONE Medical (Beijing) Co., Ltd. | Beijing | Beijing | Contract manufacturer | 7 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
Showing 12 of 14. All 14 manufacturers in China registered for Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Record
| Listed by | Aesculap AG, Germany |
|---|---|
| FDA product code | KWY |
| Device type | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3390 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2015-09-24 |
| Record revised | 2025-11-13 (version 6) |
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 |
|---|---|---|
| NK048K | Outer diameter (mm) : 48.000 MM | Withdrawn |
| NK055K | Outer diameter (mm) : 55.000 MM | Withdrawn |
| NK054K | Outer diameter (mm) : 54.000 MM | Withdrawn |
| NK057K | Outer diameter (mm) : 57.000 MM | Withdrawn |
| NK052K | Inner diameter (mm) : 28.000 MM | Withdrawn |
| NK021K | Inner diameter (mm) : 22.200 MM | Withdrawn |
| NK025K | Outer diameter (mm) : 45.000 MM | Withdrawn |
| NK047K | Inner diameter (mm) : 28.000 MM | Withdrawn |
| NK060K | Outer diameter (mm) : 60.000 MM | Withdrawn |
| NK023K | Outer diameter (mm) : 43.000 MM | Withdrawn |
| NK059K | Inner diameter (mm) : 28.000 MM | Withdrawn |
| NK050K | Inner diameter (mm) : 28.000 MM | Withdrawn |
| NK056K | Outer diameter (mm) : 56.000 MM | Withdrawn |
| NK049K | Outer diameter (mm) : 49.000 MM | Withdrawn |
| NK058K | Outer diameter (mm) : 58.000 MM | Withdrawn |
| NK024K | Outer diameter (mm) : 44.000 MM | Withdrawn |
| NK022K | Outer diameter (mm) : 42.000 MM | Withdrawn |
| NK053K | Inner diameter (mm) : 28.000 MM | Withdrawn |
| NK051K | Inner diameter (mm) : 28.000 MM | Withdrawn |
| NK026K | Inner diameter (mm) : 22.200 MM | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Resolve Modular Revision Hip Stem | United Orthopedic Corp. | 196 |
| Corin Bipolar Prosthesis | Corin Limited | 182 |
| Consensus® Hip System | Consensus Orthopedics, Inc. | 177 |
| Consensus Hip System | Shalby Advanced Technologies, Inc. | 177 |
| Instrument | Howmedica Osteonics Corp | 130 |
| Bencox Hip System | Corentec Co., Ltd. | 126 |
| United Hip System, U2 Bipolar Implant | United Orthopedic Corp. | 123 |
| MultiPolar® | Zimmer, Inc. | 100 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | Zimmer, Inc. | 96 |
| Fitmore® Hip Stem | Zimmer, Inc. | 75 |
| Arcos® Modular Revision System | Biomet Orthopedics | 67 |
| Acumatch L-Series | Exactech, Inc. | 67 |
Showing 12 of 352. All products under Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K060707 | 2006-05-31 |
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.