Humelock II Cementless Shoulder System
Humelock II Cementless is a humeral stem range used in a hemi-shoulder replacement. The stem fits into the upper arm bone and connects through a double-taper adapter to the humeral head,…
Humelock II Cementless is a humeral stem range used in a hemi-shoulder replacement. The stem fits into the upper arm bone and connects through a double-taper adapter to the humeral head, which forms the replacement joint surface.
The titanium alloy stem has a cylindrical, grit-blasted distal section with two screw holes. Its proximal section has commercially pure titanium and hydroxyapatite coatings, providing a different surface configuration at the upper stem.
Listed Item
Humelock II Stem TA6V Size 15 Cementless TI/HA
Modular Assembly
Cortical screws can secure the stem through the distal holes. The titanium alloy double-taper connector joins the stem to a cobalt-chromium-molybdenum head, with centered and offset head options. Stem sizes and head diameters vary within the system.
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 Solutions, France |
|---|---|
| FDA product code | HSD |
| Device type | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3690 |
| 510(k) | K130759 |
| Record published | 2016-06-09 |
| Record revised | 2026-07-01 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Store away from light and sunlight Store away from moisture |
| Sizes | Length 18 to 38 mm; outer diameter 12 to 15 mm |
| Distribution end date | 2026-06-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 107-4528 | Length 28 mm | In distribution |
| 107-4536 | Length 36 mm | In distribution |
| 902-0000 | In distribution | |
| 107-4522 | Length 22 mm | In distribution |
| 926-1026 | In distribution | |
| 311-0210 | In distribution | |
| 311-0214 | Outer Diameter 14 mm | In distribution |
| 107-4520 | Length 20 mm | In distribution |
| 311-0212 | Outer Diameter 12 mm | In distribution |
| 107-4524 | Length 24 mm | In distribution |
| 106-2000 | In distribution | |
| 107-4530 | Length 30 mm | In distribution |
| 902-0010 | In distribution | |
| 107-4532 | Length 32 mm | In distribution |
| 107-4518 | Length 18 mm | In distribution |
| 107-4526 | Length 26 mm | In distribution |
| 926-1019 | In distribution | |
| 107-4534 | In distribution | |
| 311-0215 | Outer Diameter 15 mm | Withdrawn |
| 107-4538 | Length 38 mm | Withdrawn |
| 107-4540 | Withdrawn | |
| 311-0213 | Outer Diameter 14 mm | Withdrawn |
| 926-0013 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Equinoxe | Exactech, Inc. | 345 |
| SMR Shoulder | Limacorporate | 182 |
| FX V135 | Fx Shoulder Solutions SAS | 127 |
| 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 |
Showing 12 of 241. All products under Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K130759 | 2013-11-09 |
| K111097 | 2011-11-09 |
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.