Balance HIP System
3 catalogue numbers from 180013, 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
3catalogue 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) | K030055 |
| Record published | 2015-10-24 |
| Record revised | 2025-05-30 (version 5) |
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 |
|---|---|---|
| 180013 | 13 SIZE 170 MM TYPE1 TAPER | In distribution |
| 180002 | 8 SIZE 145 MM TYPE1 TAPER | In distribution |
| 180010 | 12 SIZE 165 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 |
| Balance Microplasty HIP System | Biomet Orthopedics | 6 |
| 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 |
| 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
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Biomet, Inc. | 510(k) number | 2019-08-21 | Class II | Environmental control | Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. | 219988 units (total) | 2021-07-21 |
| Biomet, Inc. | 510(k) number | 2015-04-16 | Class III | Labeling mix-ups | Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect GTIN (Global Trade Identification Number) codes. | 1315 | 2016-05-16 |
| Biomet, Inc. | 510(k) number | 2015-01-09 | Class II | Packaging process control | Biomet recalled the Mallory Head 4 Finned Acetabular Shell 50mm (Lot 364600) and Ringloc + Acetabular Shell Limited Hole Finned 52 mm (Lot 427840) following a mix up in packaging with the two. | 17 | 2015-10-22 |
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.