Titan Modular Shoulder System 2.5
TSS Cocr Concentric Head. 2.5 50X22MM
8manufacturers in China registered for this device type
34catalogue numbers in this listing
1510(k) clearance
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 | Smith & Nephew, 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 | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K100448 |
| Record published | 2022-12-22 |
| Record revised | 2025-03-06 (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, expiry date |
| Storage | Special storage condition: : – |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GLN-0920-030-01P | In distribution | |
| MHH-0923-010-5022C | In distribution | |
| GLN-0920-030-02P | In distribution | |
| GLN-0920-030-00P | In distribution | |
| BOD-0923-020-10LRG | In distribution | |
| MHH-0923-010-4419E | In distribution | |
| STEM-0950-025-14 | In distribution | |
| STEM-0920-025-13 | In distribution | |
| MHH-0923-010-5220C | In distribution | |
| MHH-0923-010-4015E | In distribution | |
| STEM-0920-025-07 | In distribution | |
| GLN-0920-030-01K | In distribution | |
| STEM-0920-025-16 | In distribution | |
| MHH-0923-010-5220E | In distribution | |
| BSW-0920-01NS | In distribution | |
| STEM-0950-025-10 | In distribution | |
| MHH-0923-010-4416E | In distribution | |
| MHH-0923-010-4620E | In distribution | |
| BOD-0923-021-08LRG | In distribution | |
| GLN-0920-030-03P | In distribution | |
| STEM-0950-025-12 | In distribution | |
| MHH-0923-010-4815C | In distribution | |
| MHH-0923-010-4617C | In distribution | |
| MHH-0923-010-4821E | In distribution | |
| BOD-0923-020-10STD | In distribution | |
| BOD-0923-020-10SML | In distribution | |
| MHH-0923-010-4818C | In distribution | |
| GLN-0920-030-00K | In distribution | |
| STEM-0920-025-14 | In distribution | |
| BOD-0923-020-12STD | In distribution | |
| MHH-0923-010-4216C | In distribution | |
| MHH-0923-010-4419C | In distribution | |
| STEM-0920-025-06 | In distribution | |
| MHH-0923-010-5022E | In distribution |
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 |
|---|---|
| K121714 | 2012-09-07 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Integra Lifesciences Corporation | 510(k) number | 2014-10-24 | Class II | Nonconforming Material/Component | A single lot of left and a single lot of right Reverse Shoulder System cutting templates were manufactured incorrectly. Specifically, the threaded handle has been welded backwards on the template resulting in the cutting angle being the re | 12 units | 2015-07-21 |
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.