Dynasty
Dynasty® A-Class® 54MM 15DG Group K Crosslinked Poly Liner
4manufacturers in China registered for this device type
12catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Zhejiang (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| 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 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
Record
| Listed by | Microport Orthopedics Inc., United States |
|---|---|
| FDA product code | JDL |
| Device type | Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) |
| Device class | Class 3 |
| Regulation | 21 CFR 888.3320 |
| Establishment | Contract manufacturer, Reprocessor, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2015-10-20 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Outer diameter 48 to 76 mm; lumen/inner diameter 36 to 54 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DLXPGJ36 | Lumen/Inner Diameter 36 mm | In distribution |
| DSBFGK76 | Outer Diameter 76 mm | In distribution |
| DSBFGH68 | Outer Diameter 68 mm | In distribution |
| DSBFGF56 | Outer Diameter 56 mm | In distribution |
| DLXPLK54 | Lumen/Inner Diameter 54 mm | In distribution |
| DLXPLK36 | Lumen/Inner Diameter 36 mm | In distribution |
| DSBFGG60 | Outer Diameter 60 mm | In distribution |
| DSBFGB48 | Outer Diameter 48 mm | In distribution |
| DSBFGJ72 | Outer Diameter 72 mm | In distribution |
| DLXPGK54 | Lumen/Inner Diameter 54 mm | In distribution |
| DSBFGD52 | Outer Diameter 52 mm | In distribution |
| DSBFGH64 | Outer Diameter 64 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Consensus® Hip System | Consensus Orthopedics, Inc. | 57 |
| Consensus Hip System | Shalby Advanced Technologies, Inc. | 57 |
| Omnifit | Howmedica Osteonics Corp | 29 |
| Conserve® | Microport Orthopedics Inc. | 20 |
| Fitmore® Hip Stem | Zimmer, Inc. | 19 |
| Healey HIP System | Biomet Orthopedics | 12 |
| Transcend® | Microport Orthopedics Inc. | 6 |
| CLS® Brevius® Kinectiv® | Zimmer, Inc. | 6 |
| Arcos Modular Revision Hip System | Biomet Orthopedics | 6 |
| Duracon | Howmedica Osteonics Corp | 5 |
| Kinectiv® | Zimmer, Inc. | 3 |
| CLS® Brevius™ Stem | Zimmer, Inc. | 2 |
Showing 12 of 20. All products under Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)
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.