FX V135
Humeral CUP Centered Symmetric Standard PE/TA6V Ø36+1 / Taper Ø24
9manufacturers in China registered for this device type
131catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (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 |
|---|---|---|---|---|
| Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| Stryker Trauson (Changzhou) Medical Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 3 |
| 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 |
| Changzhou Atomic HI-Tech Radiation Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 8 |
Record
| Listed by | Fx Shoulder Solutions SAS, France |
|---|---|
| FDA product code | PHX |
| Device type | Shoulder Prosthesis, Reverse Configuration |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3660 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K223801 |
| Record published | 2025-08-26 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Keep away from sunlight and rain |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 950-2818 | In distribution | |
| 318-3612 | In distribution | |
| 318-5616 | In distribution | |
| 950-3815 | In distribution | |
| 950-5809 | In distribution | |
| 906-3200 | In distribution | |
| 950-4815 | In distribution | |
| 318-5614 | In distribution | |
| 951-1812 | In distribution | |
| 303-0801 | In distribution | |
| 202-0903 | In distribution | |
| 318-1830 | In distribution | |
| 906-4001 | In distribution | |
| 906-3261 | In distribution | |
| 906-4030 | In distribution | |
| 906-3603 | In distribution | |
| 950-6806 | In distribution | |
| 318-2021 | In distribution | |
| 950-2806 | In distribution | |
| 338-0100 | In distribution | |
| 950-6809 | In distribution | |
| 202-0806 | In distribution | |
| 318-3614 | In distribution | |
| 318-5414 | In distribution | |
| 318-5410 | In distribution | |
| 318-5212 | In distribution | |
| 318-5208 | In distribution | |
| 906-3633 | In distribution | |
| 318-1820 | In distribution | |
| 950-2809 | In distribution | |
| 318-1811 | In distribution | |
| 318-4016 | In distribution | |
| 203-0906 | In distribution | |
| 204-0803 | In distribution | |
| 338-0036 | In distribution | |
| 950-5818 | In distribution | |
| 950-4809 | In distribution | |
| 906-3230 | In distribution | |
| 950-6803 | In distribution | |
| 906-3630 | In distribution | |
| 950-3809 | In distribution | |
| 950-2815 | In distribution | |
| 302-0801 | In distribution | |
| 950-4806 | In distribution | |
| 203-0806 | In distribution | |
| 318-3616 | In distribution | |
| 950-1812 | In distribution | |
| 950-4803 | In distribution | |
| 303-0803 | In distribution | |
| 950-5812 | In distribution | |
| 318-5412 | In distribution | |
| 906-4031 | In distribution | |
| 950-6815 | In distribution | |
| 304-0806 | In distribution | |
| 906-3260 | In distribution | |
| 906-3231 | In distribution | |
| 338-0040 | In distribution | |
| 318-5612 | In distribution | |
| 303-0806 | In distribution | |
| 302-0806 | In distribution | |
| 318-1810 | In distribution | |
| 906-3600 | In distribution | |
| 318-4018 | In distribution | |
| 318-3210 | In distribution | |
| 338-0032 | In distribution | |
| 950-5803 | In distribution | |
| 950-1803 | In distribution | |
| 951-1815 | In distribution | |
| 318-2010 | In distribution | |
| 304-0809 | In distribution | |
| 204-0909 | In distribution | |
| 318-3212 | In distribution | |
| 906-4000 | In distribution | |
| 203-0007 | In distribution | |
| 204-0903 | In distribution | |
| 318-5210 | In distribution | |
| 951-1806 | In distribution | |
| 950-1809 | In distribution | |
| 906-3201 | In distribution | |
| 950-4812 | In distribution | |
| 304-0801 | In distribution | |
| 204-0806 | In distribution | |
| 950-3803 | In distribution | |
| 906-4061 | In distribution | |
| 950-1815 | In distribution | |
| 950-2812 | In distribution | |
| 202-0906 | In distribution | |
| 318-3618 | In distribution | |
| 951-1818 | In distribution | |
| 950-4818 | In distribution | |
| 202-0809 | In distribution | |
| 202-0803 | In distribution | |
| 950-3806 | In distribution | |
| 303-0809 | In distribution | |
| 203-0809 | In distribution | |
| 302-0809 | In distribution | |
| 318-1821 | In distribution | |
| 950-6812 | In distribution | |
| 318-4020 | In distribution | |
| 203-0903 | In distribution | |
| 204-0906 | In distribution | |
| 906-3663 | In distribution | |
| 906-3660 | In distribution | |
| 304-0803 | In distribution | |
| 950-1818 | In distribution | |
| 318-2020 | In distribution | |
| 906-4060 | In distribution | |
| 318-3216 | In distribution | |
| 932-0801 | In distribution | |
| 338-0038 | In distribution | |
| 950-5806 | In distribution | |
| 950-2803 | In distribution | |
| 318-2011 | In distribution | |
| 950-1806 | In distribution | |
| 318-3214 | In distribution | |
| 951-1809 | In distribution | |
| 951-1803 | In distribution | |
| 338-0044 | In distribution | |
| 204-0809 | In distribution | |
| 950-5815 | In distribution | |
| 950-3818 | In distribution | |
| 318-4014 | In distribution | |
| 950-3812 | In distribution | |
| 203-0803 | In distribution | |
| 302-0803 | In distribution | |
| 950-6818 | In distribution | |
| 203-0909 | In distribution | |
| 202-0909 | In distribution | |
| 337-0708 | In distribution | |
| 318-2030 | In distribution | |
| 338-0708 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arthrex® | Arthrex, Inc. | 297 |
| Prima TT Glenoid | Limacorporate | 129 |
| Shoulder Innovations Inset Reverse Total Shoulder | Shoulder Innovations, Inc | 124 |
| Equinoxe | Exactech, Inc. | 123 |
| Veritas rTSA | restor3d, inc. | 112 |
| DJO Surgical | Encore Medical, L.P. | 109 |
| R1 Reverse Shoulder System | Catalyst Orthoscience Inc | 100 |
| Tornier Perform™ Humeral System | Tornier Inc. | 96 |
| MSS – Monobloc stem | Medacta International SA | 92 |
| SMR Shoulder | Limacorporate | 90 |
| Humelock II Cemented Reversible Shoulder | Fx Solutions | 83 |
| Perform™ Humeral System | Tornier Inc. | 74 |
Showing 12 of 232. All products under Shoulder Prosthesis, Reverse Configuration
Recalls
1 of these is 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 |
|---|---|---|---|---|
| 2023-08-08 | Class II | Labeling mix-ups | Centered glenosphere box may contain an eccentric glenosphere. | 4 |
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.