Titan™
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…
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. The Humeral 2.5 set includes centric and eccentric humeral head trials to evaluate the size and fit of the appropriate implants. Head sizing plates are included to find the base width, as well as determine the need for concentric or eccentric, prior to trialing the humeral head. Instruments to assist with the trials and sizing are also included in the set.
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 | 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) | K062861 |
| Record published | 2017-10-09 |
| Record revised | 2023-01-25 (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 |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, serial number |
| Distribution end date | 2026-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HRA9005218WW | 1.370 in H x 2.047 in dia; Size 52-18 | In distribution |
| T95002008STD | 08 Standard | In distribution |
| T95012008STD | 08 Standard | In distribution |
| HRA9004016WW | 1.170 in H x 1.575 in dia; Size 40-16 | In distribution |
| HRA9005621WW | 1.370 in H x 2.205 in dia; Size 56-21 | In distribution |
| T95012008SML | 08 Small | In distribution |
| HRA9004415WW | 1.170 in H x 1.732 in dia; Size 44-15 | In distribution |
| HRA9004817WW | 1.270 in H x 1.890 in dia; Size 48-17 | In distribution |
| T95002008LRG | 08 Large | In distribution |
| HRA9005221WW | 1.370 in H x 2.047 in dia; Size 52-21 | In distribution |
| HRA9004820WW | 1.270 in H x 1.890 in dia; Size 48-20 | In distribution |
| HRA9004418WW | 1.170 in H x 1.732 in dia; Size 44-18 | In distribution |
| HRARTHIMP | 22.4 in L x 10.8 in W x 6.3 in H | Withdrawn |
| TITANH2IMP | Withdrawn | |
| TSS3IMP | 22.6 in L x 10.5 in W x 4.2 in H | Withdrawn |
| TSSMINIGLIMP | 22.3 in L x 9.5 in W x 5.7 in H | 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 |
|---|---|
| K071064 | 2007-06-22 |
| K062861 | 2006-10-31 |
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 | Closed |
|---|---|---|---|---|---|---|
| Ascension Orthopedics, Inc. | 510(k) number | 2018-11-16 | Class III | Vendor change control | The product was packaged with the Instructions for Use for a different product (Ascension First Choice DRUJ System Partial Ulnar Head Implant). | 2019-11-22 |
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.