Titan™ Total Shoulder System
The Titan Modular Total Shoulder System Pegged Glenoid is used in conjunction with metaphyseal bodies, humeral stems, and humeral heads in the TITAN™ Modular Total Shoulder System for total…
The Titan Modular Total Shoulder System Pegged Glenoid is used in conjunction with metaphyseal bodies, humeral stems, and humeral heads in the TITAN™ Modular Total Shoulder System for total replacement Arthroplasty and provide stable fixation, proximal bone loading, and proper head placement. The glenoid component is intended for use of correction of humeral joint due to severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis. The component is also used in repairing fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon’s experience indicates that alternative methods of treatment are unsatisfactory as well as other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. → revision of a failed primary component).
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) | K142413 |
| Record published | 2017-10-09 |
| Record revised | 2025-03-06 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2026-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SEM092002513 | 3.86 in L x.560 in dia; Size 13 | In distribution |
| M9200104416E | .630 in H x 1.768 in dia | In distribution |
| MHH-0923-010-4821E | .827 in H x 1.904 in dia | In distribution |
| M9200104818E | .709 in H x 1.922 in dia | In distribution |
| MHH-0923-010-5019E | .748 in H x 1.999 in dia | In distribution |
| SEM092002516 | 3.86 in L x.686 in dia; Size 16 | In distribution |
| BOD-0923-020-14LRG | 14 Large | In distribution |
| GLN092003003P | Size Large | In distribution |
| MHH-0923-010-4617C | .669 in H x 1.845 in dia | In distribution |
| MHH-0923-010-4620C | .787 in H x 1.827 in dia | In distribution |
| SEM092002506 | 3.86 in L x.267 in dia; Size 06 | In distribution |
| MHH-0923-010-4818E | .709 in H x 1.922 in dia | In distribution |
| SEM095002506 | 3.86 in L x.240 in dia; Size 06 | In distribution |
| B92002010SML | 10 Small | In distribution |
| SEM092002511 | 3.86 in L x.475 in dia; Size 11 | In distribution |
| SEM095002510 | 3.86 in L x.390 in dia; Size 10 | In distribution |
| MHH-0923-010-4617E | .669 in H x 1.845 in dia | In distribution |
| MHH-0923-010-4815C | .591 in H x 1.946 in dia | In distribution |
| MHH-0923-010-4818C | .709 in H x 1.922 in dia | In distribution |
| M9200104216C | .630 in H x 1.685 in dia | In distribution |
| MHH-0923-010-4416C | .630 in H x 1.768 in dia | In distribution |
| M9200104617C | .669 in H x 1.845 in dia | In distribution |
| GLN092003002P | Size Medium | In distribution |
| B92002010STD | 10 Standard | In distribution |
| MHH-0923-010-4216C | .630 in H x 1.685 in dia | In distribution |
| M9200104015E | .591 in H x 1.608 in dia | In distribution |
| BOD-0923-021-08STD | 08 Standard | In distribution |
| GLN092003002K | Size Medium | In distribution |
| M9200104419E | .749 in H x 1.749 in dia | In distribution |
| SEM092002512 | 3.86 in L x.518 in dia; Size 12 | In distribution |
| M9200104216E | .630 in H x 1.685 in dia | In distribution |
| MHH-0923-010-4419C | .748 in H x 1.749 in dia | In distribution |
| BOD-0923-020-08STD | 08 Standard | In distribution |
| SEM092002514 | 3.86 in L x.602 in dia; Size 14 | In distribution |
| MHH-0923-010-4416E | .630 in H x 1.768 in dia | In distribution |
| B92002012STD | 12 Standard | In distribution |
| BOD-0923-021-08LRG | 08 Large | In distribution |
| BOD-0923-020-10STD | 10 Standard | In distribution |
| MHH-0923-010-4614C | .551 in H x 1.872 in dia | In distribution |
| MHH-0923-010-3814E | .551 in H x 1.532 dia | In distribution |
| GLN092003000K | Size Extra Small | In distribution |
| M9200105220E | .787 in H x 2.075 in dia | In distribution |
| MHH-0923-010-4815E | .591 in H x 1.946 in dia | In distribution |
| SEM092002507 | 3.86 in L x.300 in dia; Size 07 | In distribution |
| M9200104617E | .669 in H x 1.845 in dia | In distribution |
| B92002014STD | 14 Standard | In distribution |
| MHH-0923-010-4821C | .827 in H x 1.904 in dia | In distribution |
| B92002014LRG | 14 Large | In distribution |
| BOD-0923-020-10SML | 10 Small | In distribution |
| M9200104815C | .591 in H x 1.946 in dia | In distribution |
| B92002010LRG | 10 Large | In distribution |
| M9200103814E | .551 in H x 1.532 in dia | In distribution |
| M9200105022C | .866 in H x 1.983 in dia | In distribution |
| MHH09200103814C | .551 in H x 1.532 in dia | Withdrawn |
| MHH09200104015C | .591 in H x 1.608 in dia | 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
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.
| Initiated | FDA class | Root cause | Reason | Closed |
|---|---|---|---|---|
| 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.