Humelock II Cemented Shoulder System
Humelock II cemented glenoid component replaces the socket side of the shoulder during total shoulder arthroplasty. It is made from ultra-high-molecular-weight polyethylene and uses two…
Humelock II cemented glenoid component replaces the socket side of the shoulder during total shoulder arthroplasty. It is made from ultra-high-molecular-weight polyethylene and uses two pegs for cemented fixation to glenoid bone.
Each peg contains a tantalum marker for radiographic identification. Component sizes range from extra small to extra large, allowing selection to match the reconstruction.
Listed Item
Humelock II Cemented Shoulder System, 2 PEGS GLENOID PE CEMENTED SIZE L
System Applications
The glenoid is used with the compatible Humelock II humeral components for total replacement. The system treats proximal humeral fractures, painful or disabled joints from arthritis and selected difficult reconstructions or revisions. The glenoid component requires cemented fixation.
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 Solutions, France |
|---|---|
| FDA product code | KWT |
| Device type | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3650 |
| 510(k) | K123814 |
| Record published | 2016-06-09 |
| Record revised | 2021-10-07 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Store away from light and sunlight Store away from moisture |
| Sizes | Height 27 to 39 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 105-0001 | Height 27 mm | In distribution |
| 105-0002 | Height 31 mm | In distribution |
| 105-0004 | Height 39 mm | In distribution |
| 105-0003 | Height 35 mm | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K140071 | 2014-07-28 |
| K123814 | 2013-08-13 |
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.