Shoulder System
Double Eccenter / Reverse metaphysis screw
9manufacturers in China registered for this device type
74catalogue numbers in this listing
1510(k) clearance
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 | Medacta International SA, Switzerland |
|---|---|
| FDA product code | PHX |
| Device type | Shoulder Prosthesis, Reverse Configuration |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3660 |
| Establishment | Specification developer, Repacker / relabeller, Private-label distributor, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K170452 |
| Record published | 2017-11-15 |
| Record revised | 2018-07-06 (version 3) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 04.01.0148 | In distribution | |
| 04.01.0118 | In distribution | |
| 04.01.0401 | In distribution | |
| 04.01.0409 | In distribution | |
| 04.01.0115 | In distribution | |
| 04.01.0405 | In distribution | |
| 04.01.0120 | In distribution | |
| 04.01.0169 | In distribution | |
| 04.01.0194 | In distribution | |
| 04.01.0154 | In distribution | |
| 04.01.0125 | In distribution | |
| 04.01.0170 | In distribution | |
| 04.01.0192 | In distribution | |
| 04.01.0158 | In distribution | |
| 04.01.0195 | In distribution | |
| 04.01.0152 | In distribution | |
| 04.01.0166 | In distribution | |
| 04.01.0150 | In distribution | |
| 04.01.0114 | In distribution | |
| 04.01.0168 | In distribution | |
| 04.01.0119 | In distribution | |
| 04.01.0414 | In distribution | |
| 04.01.0176 | In distribution | |
| 04.01.0413 | In distribution | |
| 04.01.0126 | In distribution | |
| 04.01.0190 | In distribution | |
| 04.01.0122 | In distribution | |
| 04.01.0191 | In distribution | |
| 04.01.0173 | In distribution | |
| 04.01.0198 | In distribution | |
| 04.01.0174 | In distribution | |
| 04.01.0112 | In distribution | |
| 04.01.0123 | In distribution | |
| 04.01.0156 | In distribution | |
| 04.01.0153 | In distribution | |
| 04.01.0200 | In distribution | |
| 04.01.0151 | In distribution | |
| 04.01.0161 | In distribution | |
| 04.01.0202 | In distribution | |
| 04.01.0160 | In distribution | |
| 04.01.0410 | In distribution | |
| 04.01.0124 | In distribution | |
| 04.01.0400 | In distribution | |
| 04.01.0111 | In distribution | |
| 04.01.0402 | In distribution | |
| 04.01.0159 | In distribution | |
| 04.01.0155 | In distribution | |
| 04.01.0157 | In distribution | |
| 04.01.0149 | In distribution | |
| 04.01.0404 | In distribution | |
| 04.01.0110 | In distribution | |
| 04.01.0165 | In distribution | |
| 04.01.0412 | In distribution | |
| 04.01.0203 | In distribution | |
| 04.01.0167 | In distribution | |
| 04.01.0199 | In distribution | |
| 04.01.0113 | In distribution | |
| 04.01.0177 | In distribution | |
| 04.01.0164 | In distribution | |
| 04.01.0197 | In distribution | |
| 04.01.0406 | In distribution | |
| 04.01.0201 | In distribution | |
| 04.01.0408 | In distribution | |
| 04.01.0193 | In distribution | |
| 04.01.0196 | In distribution | |
| 04.01.0121 | In distribution | |
| 04.01.0172 | In distribution | |
| 04.01.0117 | In distribution | |
| 04.01.0163 | In distribution | |
| 04.01.0162 | In distribution | |
| 04.01.0127 | In distribution | |
| 04.01.0178 | In distribution | |
| 04.01.0116 | In distribution | |
| 04.01.0171 | In distribution |
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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K261016 | 2026-06-10 |
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.