Vario-Cup System
The Vario-Cup safety ring is an ultra-high-molecular-weight polyethylene component that locks into the cup assembly. It is placed in a groove at the entrance of the polyethylene insert…
The Vario-Cup safety ring is an ultra-high-molecular-weight polyethylene component that locks into the cup assembly. It is placed in a groove at the entrance of the polyethylene insert after the cup and femoral components are assembled. The ring provides an anti-luxation feature intended to resist dislocation.
The associated Vario-Cup combines a polyethylene bearing with a polished cobalt-chromium-molybdenum outer casing that articulates with the bony acetabulum. It is used with femoral components from LINK Total Hip Systems. The described 22 mm inner-diameter cups have outer diameters from 39 to 43 mm.
Listed Item
Safety Ring, UHMWPE, cementless
Hip Applications
System indications include mobility-limiting disease, fractures or defects of the hip joint or proximal femur that cannot be treated conservatively or by osteosynthesis. Femoral neck fractures and correction of functional deformities are also included. The safety ring is a retention component within this hip construct.
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 | Waldemar Link GmbH & Co. KG, 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 | Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K221794 |
| Record published | 2022-08-03 |
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 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 107-200/22 | In distribution | |
| 107-230/54 | In distribution | |
| 107-230/65 | In distribution | |
| 107-230/63 | In distribution | |
| 99-0055/43 | In distribution | |
| 107-230/51 | In distribution | |
| 107-230/50 | In distribution | |
| 107-200/32 | In distribution | |
| 107-230/58 | In distribution | |
| 107-230/49 | In distribution | |
| 107-230/56 | In distribution | |
| 99-0055/40 | In distribution | |
| 107-230/53 | In distribution | |
| 99-0055/39 | In distribution | |
| 107-230/57 | In distribution | |
| 107-230/64 | In distribution | |
| 99-0055/42 | In distribution | |
| 107-230/55 | In distribution | |
| 107-230/60 | In distribution | |
| 99-0055/41 | In distribution | |
| 107-230/61 | In distribution | |
| 107-230/62 | In distribution | |
| 107-230/52 | In distribution | |
| 107-230/59 | In distribution |
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 |
|---|---|
| K221794 | 2022-07-20 |
| K781735 | 1978-10-24 |
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.