SMR Shoulder – Hybrid Glenoid
Ecc Glenosphere Dia. 36mm Extraction Insert
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) | K163397 |
| Record published | 2017-07-05 |
| Record revised | 2024-09-11 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Baseplate Extractor | In distribution | |
| 9013.79.547 | STD | In distribution |
| Trial Glenoid | SMALL – Peg L | In distribution |
| Glenoid Positioner | SMALL | In distribution |
| Removal Guide | STD | In distribution |
| Trial Glenosphere | Dia. 36 mm | In distribution |
| 9013.79.559 | LARGE LOW | In distribution |
| Glenoid Drill | L | In distribution |
| Glenoid Drill Guide | STD | In distribution |
| Central Peg Protector | In distribution | |
| Glenoid Pusher | In distribution | |
| Glenosphere Extractor Handle | In distribution | |
| Trial Glenoid | SMALL | In distribution |
| Reverse Baseplate Orienter | In distribution | |
| Glenosphere Insertion Guide | In distribution | |
| Cement Compactor | STD | In distribution |
| Trial Glenoid | STD | In distribution |
| Trial Glenoid | SMALL LOW | In distribution |
| Cannulated Reamer | In distribution | |
| Trial Glenoid | STD LOW | In distribution |
| Trial Glenosphere | Dia. 40 mm | In distribution |
| Glenoid Positioner | LARGE | In distribution |
| Glenosphere Impactor – Orienter | In distribution | |
| 9013.79.558 | STD LOW | In distribution |
| Trial Glenoid | LARGE LOW | In distribution |
| Guide | In distribution | |
| Compactor | L | In distribution |
| Glenosphere Extraction Insert | Dia. 36 mm | In distribution |
| Trial Glenoid | LARGE | In distribution |
| Trial Glenoid | LARGE – Peg L | In distribution |
| 9013.79.557 | SMALL LOW | 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
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| 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 |
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.