Fitmore® Hip Stem
Fitmore®, Hip stem, uncemented, offset B (extended)/1, taper 12/14
4manufacturers in China registered for this device type
19catalogue numbers in this listing
1510(k) clearance
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 | Zimmer, 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, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Record published | 2016-11-07 |
| Record revised | 2022-10-18 (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, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 01.00551.205 | 5 | In distribution |
| 01.00551.301 | 1 | In distribution |
| 01.00551.102 | 2 | In distribution |
| 01.00551.303 | 3 | In distribution |
| 01.00551.203 | 3 | In distribution |
| 01.00551.204 | 4 | In distribution |
| 01.00551.302 | 2 | In distribution |
| 01.00551.113 | 13 | In distribution |
| 01.00551.213 | 13 | In distribution |
| 01.00551.208 | 8 | In distribution |
| 01.00551.213 | B/13, taper 12/14 | In distribution |
| 01.00551.214 | 14 | In distribution |
| 01.00551.211 | B/11, taper 12/14 | In distribution |
| 01.00551.308 | 8 | In distribution |
| 01.00551.103 | 3 | In distribution |
| 01.00551.114 | 14 | In distribution |
| 01.00551.104 | 4 | In distribution |
| 01.00551.206 | 6 | In distribution |
| 01.00551.201 | 1 | 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 |
| Dynasty | Microport Orthopedics Inc. | 12 |
| 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)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K073499 | 2008-08-07 |
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.