Prosthesis, Hip, Hemi-, Femoral, Metal Ball
MODULAR CATHCART FRACTURE HEAD HIP BALL 48mm OD +5mm
5manufacturers in China registered for this device type
21catalogue numbers in this listing
1recall
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 | Depuy Orthopaedics, Inc., United States |
|---|---|
| FDA product code | LZY |
| Device type | Prosthesis, Hip, Hemi-, Femoral, Metal Ball |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3360 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K903084 |
| Record published | 2015-09-24 |
| Record revised | 2025-02-07 (version 7) |
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 |
|---|---|---|
| 1363-48-000 | In distribution | |
| 1363-49-000 | In distribution | |
| 1363-58-000 | In distribution | |
| 1363-53-000 | In distribution | |
| 1363-56-000 | In distribution | |
| 1363-14-000 | In distribution | |
| 1363-51-000 | In distribution | |
| 1363-42-000 | In distribution | |
| 1363-52-000 | In distribution | |
| 1363-10-000 | In distribution | |
| 1363-47-000 | In distribution | |
| 1363-12-000 | In distribution | |
| 1363-44-000 | In distribution | |
| 1363-50-000 | In distribution | |
| 1363-60-000 | In distribution | |
| 1363-08-000 | In distribution | |
| 1363-45-000 | In distribution | |
| 1363-43-000 | In distribution | |
| 1363-46-000 | In distribution | |
| 1363-41-000 | In distribution | |
| 1363-54-000 | 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 |
| 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 |
| 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
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Depuy Orthopaedics, Inc. | 510(k) number | 2022-05-18 | Class II | Labeling design | The Cathcart Ball has an inherent +5mm offset which is not currently specified in its Instructions for Use or Surgical Technique Guide. The STG has been updated to reflect the clarification that the +5mm offset should be taken into consider | 3488 |
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.