RevoMotion
Glenosphere, 32mm, +2 Lateral Offset
9manufacturers in China registered for this device type
40catalogue 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 | Arthrosurface, Inc., United States |
|---|---|
| FDA product code | PHX |
| Device type | Shoulder Prosthesis, Reverse Configuration |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3660 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K203375 |
| Record published | 2026-05-08 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8RC1-5006-A | In distribution | |
| 8RG0-4000-A | In distribution | |
| 8RG2-3600-A | In distribution | |
| 8RM2-0800-A | In distribution | |
| 8RG2-3200 | In distribution | |
| 8RS2-1030 | In distribution | |
| 8RG0-32EC-A | In distribution | |
| 8RC1-5007-A | In distribution | |
| 8RM2-1600-A | In distribution | |
| 8RC1-5008 | In distribution | |
| 8RG2-36EC-A | In distribution | |
| 8RS4-1045-A | In distribution | |
| 8RG0-40EC-A | In distribution | |
| 8RS4-1030-A | In distribution | |
| 8RS2-1020 | In distribution | |
| 8RG4-4000-A | In distribution | |
| 8RM2-0600-A | In distribution | |
| 8RM2-1200-A | In distribution | |
| 8RG0-36EC-A | In distribution | |
| 8RS2-1040 | In distribution | |
| 8RG4-3600-A | In distribution | |
| 8RC1-5004-A | In distribution | |
| 8RS2-1025 | In distribution | |
| 8RS4-1025 | In distribution | |
| 3RG4-3200-A | In distribution | |
| 8RS4-1035-A | In distribution | |
| 8RC1-5003-A | In distribution | |
| 8RG2-40EC-A | In distribution | |
| 8RS4-1020 | In distribution | |
| 8RS4-1040-A | In distribution | |
| 8RG0-3600-A | In distribution | |
| 8RM2-1000-A | In distribution | |
| 8RG2-3200-A | In distribution | |
| 8RC1-5005-A | In distribution | |
| 8RB4-2310-A | In distribution | |
| 8RM2-1400-A | In distribution | |
| 8RS2-1035 | In distribution | |
| 8RG2-32EC-A | In distribution | |
| 8RS2-1045 | In distribution | |
| 8RG2-4000-A | 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 |
|---|---|
| K203375 | 2021-06-24 |
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.