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. This humeral tray 2 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 Jiangsu (5), Shanghai (3), Zhejiang (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| Stryker Trauson (Changzhou) Medical Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 3 |
| 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 | KWS |
| Device type | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3660 |
| Establishment | Manufacturer |
| 510(k) | K130050 |
| Record published | 2016-08-15 |
| Record revised | 2023-01-25 (version 6) |
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 |
| Storage | Special storage condition: Do Not Use if Package is Damaged |
| Sizes | Outer diameter 8 to 14 mm; length 125 to 165 mm |
| Distribution end date | 2026-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TRL096005C | Size 5mm; 1.281 in H | In distribution |
| TRL096000S | Size 0S;.557 in H | In distribution |
| TRL096000R | Size 0R;.677 in H | In distribution |
| S95002508165 | Outer Diameter 8 mm | In distribution |
| TRL096003R | Size +3R;.795 in H | In distribution |
| S95002512125 | Length 125 mm | In distribution |
| TRL096009S | Size +9S;.911 in H | In distribution |
| TRL096003S | Size +3S;.675 in H | In distribution |
| TRL096006R | Size +6R;.913 in H | In distribution |
| T95012008LRG | 08 Large | In distribution |
| GLN-0926-030-02A | Medium | In distribution |
| TRL096009R | Size +9R; 1.031 in H | In distribution |
| S95002510165 | Length 165 mm | In distribution |
| TRL096006S | Size +6S;.793 in H | In distribution |
| S95002508125 | Outer Diameter 8 mm | In distribution |
| TRL096005E | Size 5mm; 1.281 in H | In distribution |
| TRL096002EL | Size 2mm; 1.163 in H | In distribution |
| GLN-0926-030-00A | X-Small | In distribution |
| S95002512165 | Length 165 mm | In distribution |
| GLN-0926-030-01A | Small | In distribution |
| TRL096002C | Size 2mm; 1.163 in H | In distribution |
| S95002510125 | Outer Diameter 10 mm | In distribution |
| TRL096002E | Size 2mm; 1.163 in H | In distribution |
| GLN-0926-030-03A | Large | In distribution |
| T95002008SML | 08 Small | In distribution |
| LNGSTMINSTP | Withdrawn | |
| TITANG1IMP | Withdrawn | |
| S095002514165 | Length 165 mm | Withdrawn |
| S095002514125 | Outer Diameter 14 mm | Withdrawn |
| TSS2IMP | 23.2 in L x 10.3 in W x 5.3 in H | Withdrawn |
| TSSREVIMP | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Equinoxe | Exactech, Inc. | 442 |
| Reunion | Stryker GmbH | 321 |
| DJO Surgical | Encore Medical, L.P. | 266 |
| SMR Shoulder | Limacorporate | 209 |
| Tornier Flex Shoulder System | Tornier Inc. | 187 |
| Anatomical Shoulder™ | Zimmer, Inc. | 166 |
| Arthrex® | Arthrex, Inc. | 154 |
| Comprehensive Shoulder System | Biomet Orthopedics | 111 |
| Flex Shoulder System | Tornier Inc. | 109 |
| Aequalis™ PerFORM+ | Tornier Inc. | 108 |
| Aequalis™ Ascend™ Flex | Tornier Inc. | 102 |
| Anatomic Shoulder Prosthesis | Medacta International SA | 90 |
Showing 12 of 326. All products under Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K152047 | 2015-12-23 |
| K142413 | 2014-11-14 |
| K100448 | 2010-08-30 |
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.