Titan™ Reverse Shoulder System
The Titan Reverse Shoulder humeral body is made of titanium. It is designed for potential increased ROM and minimized scapular notching, as well as increased visual and access to glenoid.…
The Titan Reverse Shoulder humeral body is made of titanium. It is designed for potential increased ROM and minimized scapular notching, as well as increased visual and access to glenoid. The asymmatrix coating allows for an all press fit humeral component and secondary fixation. A titanium screw is included for fixation.
9manufacturers in China registered for this device type
33catalogue numbers in this listing
3510(k) clearances naming this product code
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 | 2017-10-09 |
| Record revised | 2024-02-19 (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, manufacturing date |
| Distribution end date | 2026-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BBS096021STD | 08 Standard;.825 in L x.186 in dia Screw | In distribution |
| SSC096004540 | 43 mm L x 4.5 mm dia | In distribution |
| LNR096009S | .902 in H; Size 9 | In distribution |
| SCW096005545 | 1.720 in L x.216 in dia | In distribution |
| GLS096002C | 1.012 in H; Size 2mm | In distribution |
| LNR096000R | .668 in H; Size 0 | In distribution |
| SSC096004515 | 18 mm L x 4.5 mm dia | In distribution |
| SSC096004525 | 28 mm L x 4.5 mm dia | In distribution |
| GLS096005C | 1.130 in H; Size 5 mm | In distribution |
| SSC096004530 | 33 mm L x 4.5 mm dia | In distribution |
| SSC096004520 | 23 mm L x 4.5 mm dia | In distribution |
| SSC096004555 | 55 mm L x 4.5 mm | In distribution |
| LNR096006S | .784 in H; Size 6 | In distribution |
| SSC096004535 | 38 mm L x 4.5 mm dia | In distribution |
| SCW096005530 | 1.129 in L x.216 in dia | In distribution |
| SSC096004550 | 53 mm L x 4.5 mm dia | In distribution |
| GBP096003015 | 15 mm | In distribution |
| GLS096002EL | 1.012 in H; Size 2mm | In distribution |
| BBS096021SML | 08 Small;.825 in L x.186 in dia Screw | In distribution |
| GLS096005E | 1.130 in H; Size 5 mm | In distribution |
| SCW096005520 | 58 mm L x 4.5 mm dia | In distribution |
| BBS096021LRG | 08 Large;.825 in L x.186 in dia Screw | In distribution |
| LNR096006R | .904 in H; Size 6 | In distribution |
| GLS096002E | 1.012 in H; Size 2mm | In distribution |
| LNR096009R | 1.022 in H; Size 9 | In distribution |
| SCW096005535 | 1.326 in L x.216 in dia | In distribution |
| LNR096003R | .786 in H; Size 3 | In distribution |
| LNR096003S | .666 in H; Size 3 | In distribution |
| GBP096003025 | 25 mm | In distribution |
| SCW096005540 | 1.523 in L x.216 in dia | In distribution |
| SSC096004545 | 48 mm L x 4.5 mm dia | In distribution |
| SCW096005525 | .932 in L x.216 in dia | In distribution |
| LNR096000S | .548 in H; Size 0 | In distribution |
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.