The Titan Modular Total Shoulder System humeral set 2.5 consists of body trials and humeral stem trials. A locking body screw is included for implantation. Instruments are provided to…
The Titan Modular Total Shoulder System humeral set 2.5 consists of body trials and humeral stem trials. A locking body screw is included for implantation. Instruments are provided to facilitate the placement of the trials and screw. The Titan Modular Total Shoulder system is indicated for painful and/or disabled joints, fracture-dislocations, and other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable.
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.
Record
Regulatory record for Titan™ Modular Total Shoulder System | Listed by | Ascension Orthopedics, Inc., United States |
| FDA product code | HSD |
| Device type | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3690 |
| Establishment | Manufacturer |
| 510(k) | K142413 |
| Record published | 2015-09-22 |
| Record revised | 2023-05-03 (version 4) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | serial number |
| Distribution end date | 2023-03-31 |
Recalls
1 of these is Class III. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
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.