Titan™
RSS 4.5mm Star Screw and Cap; 50mm Length
9manufacturers in China registered for this device type
24catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (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 |
|---|---|---|---|---|
| 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 |
| Changzhou Atomic HI-Tech Radiation Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 8 |
Record
| Listed by | Ascension Orthopedics, Inc., United States |
|---|---|
| FDA product code | PHX |
| Device type | Shoulder Prosthesis, Reverse Configuration |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3660 |
| Establishment | Manufacturer |
| 510(k) | K190588 |
| Record published | 2020-01-09 |
| Record revised | 2023-05-02 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number |
| Storage | Special storage condition: Do Not Use If Package Is Damaged |
| Sizes | Length 15 to 55 mm |
| Distribution end date | 2026-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LNR-0960-191-6S | 6S | In distribution |
| LNR-0960-192-9R | 9R | In distribution |
| GLS-0961-05C-S | 5mm | In distribution |
| SCW-0961-046-50 | Length 50 mm | In distribution |
| SCW-0961-046-30 | Length 30 mm | In distribution |
| BSC-0960-021-01 | In distribution | |
| SCW-0961-046-45 | Length 45 mm | In distribution |
| GLS-0961-02E-S | 2mm | In distribution |
| SCW-0961-046-15 | Length 15 mm | In distribution |
| SCW-0961-046-35 | Length 35 mm | In distribution |
| LNR-0960-191-9S | 0.902 Inch | In distribution |
| GBP-0961-094-S | S | In distribution |
| SCW-0961-046-40 | Length 40 mm | In distribution |
| GLS-0961-02C-S | 2mm | In distribution |
| LNR-0960-191-0S | 0.548 Inch | In distribution |
| LNR-0960-192-6R | 6R | In distribution |
| SCW-0961-046-25 | Length 25 mm | In distribution |
| SCW-0961-046-20 | Length 20 mm | In distribution |
| LNR-0960-192-0R | 0R | In distribution |
| LNR-0960-191-3S | 0.666 Inch | In distribution |
| SCW-0961-046-55 | Length 55 mm | In distribution |
| LNR-0960-192-3R | 0.786 Inch | In distribution |
| GLS-0961-05E-S | 5mm | In distribution |
| TITANREVSPBTOTE | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arthrex® | Arthrex, Inc. | 297 |
| FX V135 | Fx Shoulder Solutions SAS | 131 |
| Prima TT Glenoid | Limacorporate | 129 |
| Shoulder Innovations Inset Reverse Total Shoulder | Shoulder Innovations, Inc | 124 |
| Equinoxe | Exactech, Inc. | 123 |
| Veritas rTSA | restor3d, inc. | 112 |
| DJO Surgical | Encore Medical, L.P. | 109 |
| R1 Reverse Shoulder System | Catalyst Orthoscience Inc | 100 |
| Tornier Perform™ Humeral System | Tornier Inc. | 96 |
| MSS – Monobloc stem | Medacta International SA | 92 |
| SMR Shoulder | Limacorporate | 90 |
| Humelock II Cemented Reversible Shoulder | Fx Solutions | 83 |
Showing 12 of 232. All products under Shoulder Prosthesis, Reverse Configuration
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.