FX V135
Trial Humeral CUP Centered Symmetric Standard Ø36+9 / Taper Ø24
6manufacturers in China registered for this device type
27catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (2), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| 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 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Fx Shoulder Solutions SAS, France |
|---|---|
| FDA product code | KWT |
| Device type | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3650 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K254154 |
| Record published | 2026-06-30 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 938-0007 | In distribution | |
| 938-0438 | In distribution | |
| 938-0542 | In distribution | |
| 938-0338 | In distribution | |
| 938-0336 | In distribution | |
| 938-0536 | In distribution | |
| 933-0809 | In distribution | |
| 938-0436 | In distribution | |
| 938-0340 | In distribution | |
| 938-0332 | In distribution | |
| 938-0230 | In distribution | |
| 932-0806 | In distribution | |
| 938-0006 | In distribution | |
| 932-0803 | In distribution | |
| 934-0801 | In distribution | |
| 933-0801 | In distribution | |
| 933-0803 | In distribution | |
| 933-0806 | In distribution | |
| 938-0432 | In distribution | |
| 938-0344 | In distribution | |
| 938-0440 | In distribution | |
| 934-0806 | In distribution | |
| 932-0809 | In distribution | |
| 938-0300 | In distribution | |
| 938-0444 | In distribution | |
| 934-0803 | In distribution | |
| 934-0809 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Equinoxe | Exactech, Inc. | 336 |
| SMR Shoulder | Limacorporate | 289 |
| Tornier Perform Humeral System | Tornier Inc. | 119 |
| Bigliani/Flatow® | Zimmer, Inc. | 119 |
| Trabecular Metal® | Zimmer, Inc. | 115 |
| Jarvis Glenoid Rerverse Shoulder Prosthesis | Fournitures Hospitalieres Industrie | 103 |
| Comprehensive® Shoulder System | Biomet Orthopedics | 86 |
| Alliance® | Zimmer, Inc. | 68 |
| Anatomical Shoulder™ | Zimmer, Inc. | 54 |
| Aetos Shoulder System | Smith & Nephew, Inc. | 53 |
| Perform™ Humeral System | Tornier Inc. | 47 |
| Bio-Modular® Shoulder System | Biomet Orthopedics | 43 |
Showing 12 of 164. All products under Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
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.