SMR System
SMR System - Reverse HP Lateralizing Liner Medium Dia. 44mm
9manufacturers in China registered for this device type
31catalogue 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 | Limacorporate, Italy |
|---|---|
| FDA product code | PHX |
| Device type | Shoulder Prosthesis, Reverse Configuration |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3660 |
| 510(k) | K243826 |
| Record published | 2025-09-06 |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1374.50.400 | Dia. 40mm | In distribution |
| 1365.09.015 | Medium Dia. 40mm | In distribution |
| 1374.15.310 | Small Standard | In distribution |
| 1365.09.120 | Long Dia. 40mm | In distribution |
| 1362.09.120 | Lateralizing Long Dia. 44mm | In distribution |
| 1361.50.810 | Standard | In distribution |
| 1374.54.444 | Correction Dia. 44mm | In distribution |
| 9013.75.394 | In distribution | |
| 1365.09.020 | Long Dia. 40mm | In distribution |
| 1309.15.136 | Dia. 13 mm H. 180 mm | In distribution |
| 1365.09.010 | Short Dia. 40mm | In distribution |
| 1362.09.010 | Short Dia. 44mm | In distribution |
| 1309.15.134 | Dia. 13 mm H. 150 mm | In distribution |
| 1374.15.305 | Small-R | In distribution |
| 9CC0.95.096 | In distribution | |
| 1362.09.015 | Medium Dia. 44mm | In distribution |
| 1361.50.815 | +3mm | In distribution |
| 1352.15.050 | In distribution | |
| 1374.54.400 | Dia. 40mm | In distribution |
| 1352.15.001 | In distribution | |
| 1361.50.820 | +6mm | In distribution |
| 1308.15.144 | Dia. 14 mm H. 150 mm | In distribution |
| 1374.54.440 | Dia. 44mm | In distribution |
| 1362.09.115 | Lateralizing Medium Dia. 44mm | In distribution |
| 1374.09.110 | Dia. 36 mm | In distribution |
| 1308.15.136 | Dia. 13 mm H. 180 mm | In distribution |
| 1362.09.020 | Long Dia. 44mm | In distribution |
| 1308.15.156 | Dia. 15 mm H. 180 mm | In distribution |
| 1365.09.115 | Medium Dia. 40mm | In distribution |
| 1308.15.134 | Dia. 13 mm H. 150 mm | In distribution |
| 1374.09.105 | Dia. 36 mm Small-R | 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
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Limacorporate S.p.A. | 510(k) number | 2023-02-21 | Class II | Process control | Shoulder glenoid fossa prosthesis was manufactured without tantalum markers so in the absence of the markers, on already implanted devices, a correct radiographic assessment of the hybrid glenoid position can be performed by the evaluation | 1 | |
| Limacorporate S.p.A. | 510(k) number | 2016-04-08 | Class II | Component design/selection | Complaints of intra-operative breakage of the glenosphere impactors/extractors. | 314 units | 2016-12-05 |
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.