Humeris Shoulder
Humeris Shoulder includes titanium alloy humeral stems used in anatomic or reverse shoulder replacement constructs. A female taper at the top of each stem accepts compatible components for…
Humeris Shoulder includes titanium alloy humeral stems used in anatomic or reverse shoulder replacement constructs. A female taper at the top of each stem accepts compatible components for the selected joint configuration.
Cementless stems have a plasma-sprayed commercially pure titanium and hydroxyapatite coating on the proximal portion. Cemented stems provide a separate fixation option; both have a polished, trapezoidal distal section.
Listed Item
HUMERIS STEM TA6V SIZE 14 CEMENTLESS Ti/HA
Anatomic Components
For an anatomic construct, taper connectors or spacers join the stem to a cobalt-chromium-molybdenum humeral head. Centered and offset heads and different connectors adjust the head position. Polyethylene glenoid components use cemented pegs, with tantalum markers in specified pegs for radiographic visibility.
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 Solutions, France |
|---|---|
| FDA product code | PHX |
| Device type | Shoulder Prosthesis, Reverse Configuration |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3660 |
| 510(k) | K163669 |
| Record published | 2017-05-22 |
| Record revised | 2026-07-01 (version 5) |
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 |
| Storage | Special storage condition: Store away from light and sunlight Store away from moisture |
| Distribution end date | 2026-06-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 316-0014 | SIZE 14 | In distribution |
| 316-0012 | SIZE 12 | In distribution |
| 316-0018 | Size 18 | In distribution |
| 316-0016 | SIZE 16 | In distribution |
| 911-1030 | In distribution | |
| 316-0010 | SIZE 10 | In distribution |
| 316-0015 | SIZE 15 | In distribution |
| 316-0011 | SIZE 11 | In distribution |
| 316-0019 | Size 19 | Withdrawn |
| 316-0113 | SIZE 13 | Withdrawn |
| 316-0106 | SIZE 06 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arthrex® | Arthrex, Inc. | 297 |
| FX V135 | Fx Shoulder Solutions SAS | 131 |
| 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 |
Showing 12 of 232. All products under Shoulder Prosthesis, Reverse Configuration
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K163669 | 2017-05-17 |
| K162455 | 2017-01-17 |
| K150488 | 2015-11-13 |
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.