Solitude Unipolar
-3mm 12/14 Offset Adapter
10manufacturers in China registered for this device type
28catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (4), Shanghai (3), Zhejiang (2). 6 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 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Xian Airfoil Technology Co., Ltd. | Xian | Shaanxi | Contract manufacturer | 8 |
| 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 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Ortho Development Corp., United States |
|---|---|
| FDA product code | KWL |
| Device type | Prosthesis, Hip, Hemi-, Femoral, Metal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3360 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K042973 |
| Record published | 2015-08-31 |
| Record revised | 2018-07-06 (version 3) |
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 |
| Sizes | Outer diameter 38 to 60 mm; length 3 to 9 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 132-1230 | In distribution | |
| 132-0051 | Outer Diameter 51 mm | In distribution |
| 132-1203 | Length 3 mm | In distribution |
| 132-0039 | Outer Diameter 39 mm | In distribution |
| 132-0057 | Outer Diameter 57 mm | In distribution |
| 132-0040 | Outer Diameter 40 mm | In distribution |
| 132-0052 | Outer Diameter 52 mm | In distribution |
| 132-1209 | Length 9 mm | In distribution |
| 132-1206 | Length 6 mm | In distribution |
| 132-0059 | Outer Diameter 59 mm | In distribution |
| 132-0054 | Outer Diameter 54 mm | In distribution |
| 132-0060 | Outer Diameter 60 mm | In distribution |
| 132-0044 | Outer Diameter 44 mm | In distribution |
| 132-0046 | Outer Diameter 46 mm | In distribution |
| 132-0038 | Outer Diameter 38 mm | In distribution |
| 132-0055 | Outer Diameter 55 mm | In distribution |
| 132-0056 | Outer Diameter 56 mm | In distribution |
| 132-1200 | In distribution | |
| 132-0048 | Outer Diameter 48 mm | In distribution |
| 132-0058 | Outer Diameter 58 mm | In distribution |
| 132-0050 | Outer Diameter 50 mm | In distribution |
| 132-0042 | Outer Diameter 42 mm | In distribution |
| 132-0041 | Outer Diameter 41 mm | In distribution |
| 132-0047 | Outer Diameter 47 mm | In distribution |
| 132-0053 | Outer Diameter 53 mm | In distribution |
| 132-0049 | Outer Diameter 49 mm | In distribution |
| 132-0045 | Outer Diameter 45 mm | In distribution |
| 132-0043 | Outer Diameter 43 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ustar II Knee System | United Orthopedic Corp. | 115 |
| Consensus Hip System | Shalby Advanced Technologies, Inc. | 95 |
| Consensus® Hip System | Consensus Orthopedics, Inc. | 95 |
| Instrument | Howmedica Osteonics Corp | 94 |
| UHR | Howmedica Osteonics Corp | 75 |
| Austin Moore | Howmedica Osteonics Corp | 67 |
| B-P Total HIP System | Endotec, Inc. | 66 |
| CS2 Acetabular Cup System | Consensus Orthopedics, Inc. | 64 |
| DJO Surgical | Encore Medical, L.P. | 62 |
| Restoration | Howmedica Osteonics Corp | 56 |
| Optimom Modular Heads | Corin Limited | 49 |
| Corin Unipolar Modular Head | Corin Limited | 36 |
Showing 12 of 167. All products under Prosthesis, Hip, Hemi-, Femoral, Metal
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K042973 | 2005-01-27 |
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.