R1 Reverse Shoulder System
Peripheral Compression Screw 4.5mm - 36mm
9manufacturers in China registered for this device type
100catalogue numbers in this listing
6510(k) clearances naming this product code
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 | Catalyst Orthoscience 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, Repacker / relabeller, Manufacturer |
| 510(k) | K202611 |
| Record published | 2021-03-03 |
| Record revised | 2023-05-03 (version 2) |
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 |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Sterile instruments should be stored in a limited access area that is well ventilated and provides protection from dust, |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1230-4223-002 | In distribution | |
| 1230-4213-002 | In distribution | |
| 1230-7506-001 | In distribution | |
| 1230-4259 | In distribution | |
| 1230-4264 | In distribution | |
| 1230-7514-001 | In distribution | |
| 1230-7509-001 | In distribution | |
| 1230-4262 | In distribution | |
| 1230-7512-002 | In distribution | |
| 1230-4292 | In distribution | |
| 1230-5206 | In distribution | |
| 1230-7505-001 | In distribution | |
| 1230-4243 | In distribution | |
| 1230-4212-001 | In distribution | |
| 1230-4261 | In distribution | |
| 1230-7503-001 | In distribution | |
| 1230-7503-002 | In distribution | |
| 1230-5208 | In distribution | |
| 1230-7505-002 | In distribution | |
| 1230-7503-004 | In distribution | |
| 1230-4202 | In distribution | |
| 1230-7505-004 | In distribution | |
| 1230-4224-001 | In distribution | |
| 1230-4211-002 | In distribution | |
| 1230-7514-002 | In distribution | |
| 1230-4227 | In distribution | |
| 1230-5209-001 | In distribution | |
| 1230-5213 | In distribution | |
| 1230-4242 | In distribution | |
| 1230-7516-007 | In distribution | |
| 1230-5201 | In distribution | |
| 1230-7501-001 | In distribution | |
| 1230-7501-002 | In distribution | |
| 1230-7507-001 | In distribution | |
| 1230-4263 | In distribution | |
| 1226-4074 | In distribution | |
| 1230-5211 | In distribution | |
| 1230-4241-002 | In distribution | |
| 1230-7504-002 | In distribution | |
| 1230-7511-007 | In distribution | |
| 1230-4225-002 | In distribution | |
| 1230-5212 | In distribution | |
| 1230-7516-003 | In distribution | |
| 1230-4276 | In distribution | |
| 1230-5205 | In distribution | |
| 1230-4293 | In distribution | |
| 1230-4214 | In distribution | |
| 1230-9010 | In distribution | |
| 1230-7516-006 | In distribution | |
| 1230-7508-003 | In distribution | |
| 1230-5210 | In distribution | |
| 1230-7508-001 | In distribution | |
| 1230-4212-002 | In distribution | |
| 1230-7502-002 | In distribution | |
| 1230-4253 | In distribution | |
| 1230-5204 | In distribution | |
| 1230-7505-003 | In distribution | |
| 1230-7509-002 | In distribution | |
| 1230-4255 | In distribution | |
| 1230-7508-002 | In distribution | |
| 1230-4226 | In distribution | |
| 1230-7504-004 | In distribution | |
| 1230-7516-004 | In distribution | |
| 1230-7502-001 | In distribution | |
| 1230-7513-002 | In distribution | |
| 1230-7504-003 | In distribution | |
| 1230-5202 | In distribution | |
| 1230-7511-005 | In distribution | |
| 1230-5209-002 | In distribution | |
| 1230-4281 | In distribution | |
| 1230-4223-001 | In distribution | |
| 1230-7511-003 | In distribution | |
| 1230-4222 | In distribution | |
| 1230-7516-005 | In distribution | |
| 1230-7503-003 | In distribution | |
| 1230-4241-001 | In distribution | |
| 1230-7516-001 | In distribution | |
| 1230-4224-002 | In distribution | |
| 1230-7504-001 | In distribution | |
| 1230-4286 | In distribution | |
| 1230-7512-001 | In distribution | |
| 1230-4211-001 | In distribution | |
| 1230-7511-004 | In distribution | |
| 1230-7513-001 | In distribution | |
| 1230-4289 | In distribution | |
| 1230-7511-006 | In distribution | |
| 1230-5207 | In distribution | |
| 1230-4201 | In distribution | |
| 1230-4213-001 | In distribution | |
| 1226-4124 | In distribution | |
| 1230-4203 | In distribution | |
| 1230-4225-001 | In distribution | |
| 1230-4217 | In distribution | |
| 1230-4256 | In distribution | |
| 1230-4258 | In distribution | |
| 1230-4260 | In distribution | |
| 1230-7511-002 | In distribution | |
| 1230-7516-002 | In distribution | |
| 1230-7515-001 | In distribution | |
| 1230-7511-001 | 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 |
| 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 |
| Perform™ Humeral System | Tornier Inc. | 74 |
Showing 12 of 232. All products under Shoulder Prosthesis, Reverse Configuration
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K234105 | 2024-04-05 |
| K232583 | 2023-09-20 |
| K223655 | 2023-05-09 |
| K213349 | 2022-06-23 |
| K211991 | 2021-07-28 |
| K202611 | 2021-02-12 |
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.