Balance Microplasty HIP System
6 catalogue numbers from 180220, listed by Biomet Orthopedics, United States, under Prosthesis, Hip, Hemi-, Femoral, Metal Ball. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
6catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Jiangsu (2), Zhejiang (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Biomet Orthopedics, United States |
|---|---|
| FDA product code | LZY |
| Device type | Prosthesis, Hip, Hemi-, Femoral, Metal Ball |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3360 |
| 510(k) | K050251 |
| Record published | 2015-10-24 |
| Record revised | 2025-05-30 (version 4) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 180220 | 17 SIZE 80 MM TYPE1 TAPER | In distribution |
| 180215 | 14 SIZE 80 MM TYPE1 TAPER | In distribution |
| 180223 | 18 SIZE 80 MM TYPE1 TAPER | In distribution |
| 180208 | 11 SIZE 80 MM TYPE1 TAPER | In distribution |
| 180205 | 9 SIZE 80 MM TYPE1 TAPER | In distribution |
| 180202 | 8 SIZE 80 MM TYPE1 TAPER | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Endohead | Medacta International SA | 51 |
| Quadra P femoral stems | Medacta International SA | 27 |
| Tandem | Smith & Nephew, Inc. | 24 |
| Prosthesis, Hip, Hemi-, Femoral, Metal Ball | Depuy Orthopaedics, Inc. | 21 |
| B-P Total HIP System | Endotec, Inc. | 20 |
| Prosthesis, Hip, Hemi-, Femoral, Metal Ball | Smith & Nephew, Inc. | 4 |
| Sirius® Hip System | Biomet Orthopedics | 3 |
| Taperloc Microplasty HIP System | Biomet Orthopedics | 3 |
| Sirius | Biomet Orthopedics | 3 |
| Balance HIP System | Biomet Orthopedics | 3 |
| Cureguard | Jiangsu Cureguard Glove Co., Ltd. | 1 |
| Masterloc Femoral Stems | Medacta International SA | 1 |
Showing 12 of 13. All products under Prosthesis, Hip, Hemi-, Femoral, Metal Ball
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.