FX V135
Stability Trial CUP 135°/145° FOR Implant FX V 135 Ø32 + 12
8manufacturers in China registered for this device type
127catalogue numbers in this listing
2recalls on this code
Who Else Makes It
Concentrated in Shanghai (3), Jiangsu (3), 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 |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| 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 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Fx Shoulder Solutions SAS, France |
|---|---|
| FDA product code | HSD |
| Device type | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3690 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K213117 |
| 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 |
|---|---|---|
| 951-6909 | In distribution | |
| 951-4803 | In distribution | |
| 951-4334 | In distribution | |
| 951-5918 | In distribution | |
| 951-4134 | In distribution | |
| 951-4809 | In distribution | |
| 951-2806 | In distribution | |
| 951-8903 | In distribution | |
| 951-8809 | In distribution | |
| 951-4812 | In distribution | |
| 951-7912 | In distribution | |
| 951-9912 | In distribution | |
| 951-3902 | In distribution | |
| 951-8918 | In distribution | |
| 951-3918 | In distribution | |
| 951-8909 | In distribution | |
| 951-1912 | In distribution | |
| 951-5815 | In distribution | |
| 951-5906 | In distribution | |
| 951-9915 | In distribution | |
| 951-9903 | In distribution | |
| 951-8806 | In distribution | |
| 951-8818 | In distribution | |
| 951-6915 | In distribution | |
| 951-5812 | In distribution | |
| 951-8812 | In distribution | |
| 951-3903 | In distribution | |
| 951-4132 | In distribution | |
| 951-5032 | In distribution | |
| 951-5912 | In distribution | |
| 951-2903 | In distribution | |
| 951-2803 | In distribution | |
| 951-1909 | In distribution | |
| 951-3803 | In distribution | |
| 951-7809 | In distribution | |
| 951-6806 | In distribution | |
| 951-7818 | In distribution | |
| 951-8815 | In distribution | |
| 951-1903 | In distribution | |
| 951-6809 | In distribution | |
| 951-6818 | In distribution | |
| 951-7812 | In distribution | |
| 951-8915 | In distribution | |
| 951-5806 | In distribution | |
| 951-7815 | In distribution | |
| 951-9818 | In distribution | |
| 951-7903 | In distribution | |
| 951-4906 | In distribution | |
| 951-9909 | In distribution | |
| 951-6815 | In distribution | |
| 951-7906 | In distribution | |
| 606-0420 | In distribution | |
| 951-9803 | In distribution | |
| 951-2906 | In distribution | |
| 951-8906 | In distribution | |
| 951-3932 | In distribution | |
| 951-9918 | In distribution | |
| 951-4632 | In distribution | |
| 951-6918 | In distribution | |
| 951-2909 | In distribution | |
| 951-3812 | In distribution | |
| 951-9906 | In distribution | |
| 951-5903 | In distribution | |
| 951-4909 | In distribution | |
| 951-3806 | In distribution | |
| 951-6803 | In distribution | |
| 951-5818 | In distribution | |
| 951-5803 | In distribution | |
| 951-4102 | In distribution | |
| 951-6903 | In distribution | |
| 951-1906 | In distribution | |
| 951-4634 | In distribution | |
| 951-2809 | In distribution | |
| 951-6906 | In distribution | |
| 951-2915 | In distribution | |
| 951-4802 | In distribution | |
| 951-7803 | In distribution | |
| 951-2818 | In distribution | |
| 951-4903 | In distribution | |
| 951-3934 | In distribution | |
| 951-2812 | In distribution | |
| 951-2912 | In distribution | |
| 951-3909 | In distribution | |
| 951-6912 | In distribution | |
| 951-4818 | In distribution | |
| 951-7806 | In distribution | |
| 951-9815 | In distribution | |
| 951-7915 | In distribution | |
| 951-9809 | In distribution | |
| 951-3915 | In distribution | |
| 951-8803 | In distribution | |
| 951-4806 | In distribution | |
| 951-4332 | In distribution | |
| 951-4918 | In distribution | |
| 951-4915 | In distribution | |
| 951-3818 | In distribution | |
| 951-1915 | In distribution | |
| 951-3906 | In distribution | |
| 951-2815 | In distribution | |
| 951-3815 | In distribution | |
| 951-4304 | In distribution | |
| 951-5915 | In distribution | |
| 951-5034 | In distribution | |
| 951-4604 | In distribution | |
| 951-5809 | In distribution | |
| 951-1918 | In distribution | |
| 951-4815 | In distribution | |
| 951-4834 | In distribution | |
| 951-5004 | In distribution | |
| 951-7909 | In distribution | |
| 951-5002 | In distribution | |
| 951-6812 | In distribution | |
| 951-3912 | In distribution | |
| 951-9812 | In distribution | |
| 951-4104 | In distribution | |
| 951-4832 | In distribution | |
| 951-4602 | In distribution | |
| 951-5909 | In distribution | |
| 951-7918 | In distribution | |
| 951-3904 | In distribution | |
| 951-4302 | In distribution | |
| 951-4912 | In distribution | |
| 951-4804 | In distribution | |
| 951-3809 | In distribution | |
| 951-9806 | In distribution | |
| 951-2918 | In distribution | |
| 951-8912 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Equinoxe | Exactech, Inc. | 345 |
| SMR Shoulder | Limacorporate | 182 |
| Acumed | Acumed LLC | 112 |
| Promos | Smith & Nephew, Inc. | 104 |
| Trabecular Metal® | Zimmer, Inc. | 90 |
| Bigliani/Flatow® | Zimmer, Inc. | 86 |
| Comprehensive® Shoulder System | Biomet Orthopedics | 85 |
| Arthrex® | Arthrex, Inc. | 75 |
| SMR System | Limacorporate | 72 |
| DJO Surgical | Encore Medical, L.P. | 70 |
| Humeris Shoulder | Fx Solutions | 69 |
| Prima | Limacorporate | 67 |
Showing 12 of 241. All products under Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2018-06-04 | Class II | Package design/selection | Breach in the external blister of certain lots of Humelock Offset Head 50 X 20 and Centered Head 50 X 19. | 145 units | 2019-04-05 |
| 2018-06-04 | Class II | Package design/selection | Breach in the external blister of certain lots of Humelock Offset Head 50 X 20 and Centered Head 50 X 19. | 131 units | 2019-04-05 |
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.