Ring-LOK
Ring-Lok is a modular bipolar hip-head system with a factory-assembled polyethylene liner inside a cobalt-chromium outer shell. A polyethylene retention ring secures the compatible femoral…
Ring-Lok is a modular bipolar hip-head system with a factory-assembled polyethylene liner inside a cobalt-chromium outer shell. A polyethylene retention ring secures the compatible femoral head within the liner.
The head snap-fits into the bipolar liner, and the assembly is used with specified previously cleared femoral stems. Dedicated instruments support assembly and placement.
Listed Item
Modular Bi-Polar 41mm Dia. (22.225 Head) For Uncemented Applications
Head Sizes
Outer head diameters range from 38 to 62 mm in 1 mm steps. Inner bearing sizes accommodate 22.225, 26 or 28 mm femoral heads. The outer shell and inner liner provide the two articulating parts of the bipolar reconstruction.
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 | Implants Intl. Ltd., United Kingdom |
|---|---|
| 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, Manufacturer |
| 510(k) | K132539 |
| Record published | 2016-07-31 |
| Record revised | 2024-04-08 (version 4) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Special storage condition: Room temperature and Dry |
| Sizes | Outer diameter 38 to 62 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Modular Bi-Polar (52mm- 28mm Head) | Outer Diameter 52 mm | In distribution |
| Modular Bi-Polar (41mm- 22.225 Head) | Outer Diameter 41 mm | In distribution |
| Modular Bi-Polar (53mm- 28mm Head) | Outer Diameter 53 mm | In distribution |
| Modular Bi-Polar (61mm- 28mm Head) | Outer Diameter 61 mm | In distribution |
| Modular Bi-Polar (55mm- 28mm Head) | Outer Diameter 55 mm | In distribution |
| Modular Bi-Polar (44mm- 22.225 Head) | Outer Diameter 44 mm | In distribution |
| Modular Bi-Polar (46mm- 28mm Head) | Outer Diameter 46 mm | In distribution |
| Modular Bi-Polar (60mm- 28mm Head) | Outer Diameter 60 mm | In distribution |
| Modular Bi-Polar (45mm- 26mm Head) | Outer Diameter 45 mm | In distribution |
| Modular Bi-Polar (48mm- 28mm Head) | Outer Diameter 48 mm | In distribution |
| Modular Bi-Polar (42mm- 22.225 Head) | Outer Diameter 42 mm | In distribution |
| Modular Bi-Polar (49mm- 28mm Head) | Outer Diameter 49 mm | In distribution |
| Modular Bi-Polar (39mm- 22.225 Head) | Outer Diameter 39 mm | In distribution |
| Modular Bi-Polar (43mm- 26mm Head) | Outer Diameter 43 mm | In distribution |
| Modular Bi-Polar (47mm- 28mm Head) | Outer Diameter 47 mm | In distribution |
| Modular Bi-Polar (44mm- 26mm Head) | Outer Diameter 44 mm | In distribution |
| Modular Bi-Polar (38mm- 22.225 Head) | Outer Diameter 38 mm | In distribution |
| Modular Bi-Polar (59mm- 28mm Head) | Outer Diameter 59 mm | In distribution |
| Modular Bi-Polar (56mm- 28mm Head) | Outer Diameter 56 mm | In distribution |
| Modular Bi-Polar (50mm- 28mm Head) | Outer Diameter 50 mm | In distribution |
| Modular Bi-Polar (42mm- 26mm Head) | Outer Diameter 42 mm | In distribution |
| Modular Bi-Polar (62mm- 28mm Head) | Outer Diameter 62 mm | In distribution |
| Modular Bi-Polar (43mm- 22.225 Head) | Outer Diameter 43 mm | In distribution |
| Modular Bi-Polar (57mm- 28mm Head) | Outer Diameter 57 mm | In distribution |
| Modular Bi-Polar (51mm- 28mm Head) | Outer Diameter 51 mm | In distribution |
| Modular Bi-Polar (45mm- 22.225 Head) | Outer Diameter 45 mm | In distribution |
| Modular Bi-Polar (58mm- 28mm Head) | Outer Diameter 58 mm | In distribution |
| Modular Bi-Polar (40mm- 22.225 Head) | Outer Diameter 40 mm | In distribution |
| Modular Bi-Polar (54mm- 28mm Head) | Outer Diameter 54 mm | 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 |
|---|---|
| K132539 | 2014-02-07 |
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.