SMR Shoulder
SMR Shoulder - TT HYBRID Glenoid Baseplate STANDARD LOW +2 - PEG L
9manufacturers in China registered for this device type
90catalogue 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) | K142139 |
| Record published | 2020-03-19 |
| Record revised | 2022-07-04 (version 5) |
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 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9013.75.379 | +2 mm | In distribution |
| Trial Reverse Retentive Liner | Dia. 40mm # STD | In distribution |
| 1360.54.820 | Dia. 36 mm, +6mm | In distribution |
| Glenosphere | Dia. 36 mm | In distribution |
| 9013.75.380 | +4 mm | In distribution |
| 9013.75.880 | Superior-Right 15° | In distribution |
| 9013.75.377 | 15° | In distribution |
| 1365.54.815 | Dia. 40 mm, +3mm | In distribution |
| 1379.59.310 | LARGE – PEG S | In distribution |
| Liner | Dia. 40mm STD | In distribution |
| 9013.75.314 | 0° | In distribution |
| 1379.59.222 | STANDARD LOW +2 – PEG L | In distribution |
| Bone Graft Instrument Set | S 15° | In distribution |
| Bone Graft Instrument Set | 20° | In distribution |
| Bone Graft Instrument Set | SMALL-R | In distribution |
| Bone Graft Instrument Set | 5 mm | In distribution |
| 9013.75.346 | SMALL-R #LONG | In distribution |
| 9013.75.345 | SMALL-R #MEDIUM | In distribution |
| 9013.75.333 | 15° | In distribution |
| 9013.75.368 | 19° | In distribution |
| 1360.54.810 | Dia. 36 mm, Standard | In distribution |
| 1379.59.312 | LARGE +2 – PEG S | In distribution |
| 9013.75.876 | Superior-Right 7° | In distribution |
| 9013.75.348 | In distribution | |
| Bone Graft Instrument Set | 15° | In distribution |
| 1379.59.320 | LARGE LOW – PEG L | In distribution |
| Glenosphere | Dia. 40mm | In distribution |
| Bone Graft Instrument Set | In distribution | |
| 9013.74.652 | Dia. 40-44mm RIGHT | In distribution |
| 9013.74.651 | Dia. 40-44mm LEFT | In distribution |
| 9013.75.357 | 15° and 19° defects | In distribution |
| 1379.59.332 | LARGE +2 – PEG L | In distribution |
| 9013.75.886 | Posterior 19° | In distribution |
| Bone Graft Instrument Set | Superior Right 20° | In distribution |
| 9013.75.376 | 10° | In distribution |
| 1365.54.820 | Dia. 40 mm, +6mm | In distribution |
| 9013.75.344 | SMALL-R # X-LONG | In distribution |
| 1379.59.232 | STANDARD +2 – PEG L | In distribution |
| Bone Graft Instrument Set | Posterior 15° | In distribution |
| Bone Graft Instrument Set | SMALL-R/SMALL | In distribution |
| Liner | Dia. 40mm +3 | In distribution |
| Trial Reverse Retentive Liner | +6 Dia. 40mm | In distribution |
| Bone Graft Instrument Set | Superior Left 15° | In distribution |
| 1379.59.302 | LARGE LOW +2 – PEG S | In distribution |
| Trial Reverse Retentive Liner | +3 Dia. 40mm | In distribution |
| Bone Graft Instrument Set | In distribution | |
| 1360.54.821 | Dia. 36 mm, Retentive +6mm | In distribution |
| 1365.54.821 | Dia. 40 mm, Retentive +6mm | In distribution |
| 9013.75.878 | Superior-Right 10° | In distribution |
| 1376.09.051 | Dia. 42 mm | In distribution |
| 1379.59.322 | LARGE LOW +2 – PEG L | In distribution |
| Bone Graft Instrument Set | 10 mm | In distribution |
| Bone Graft Instrument Set | 10 mm | In distribution |
| 9013.75.882 | Superior-Right 19° | In distribution |
| 9013.75.874 | In distribution | |
| 9013.75.366 | 10° | In distribution |
| Bone Graft Instrument Set | In distribution | |
| Reverse Trial Liner | +6 Dia. 40mm | In distribution |
| 1379.59.330 | LARGE – PEG L | In distribution |
| Bone Graft Instrument Set | S 15° ANT | In distribution |
| Bone Graft Instrument Set | 5 mm | In distribution |
| 1379.59.220 | STANDARD LOW – PEG L | In distribution |
| 9013.74.605 | In distribution | |
| Trial Glenosphere | Dia. 40mm | In distribution |
| 1360.54.815 | Dia. 36 mm, +3mm | In distribution |
| Trial Glenosphere | Dia.40 mm | In distribution |
| Bone Graft Instrument Set | SMALL-R 10 mm | In distribution |
| 1379.59.230 | STANDARD – PEG L | In distribution |
| 1365.54.810 | Dia. 40 mm, Standard | In distribution |
| 9013.75.394 | In distribution | |
| Reverse Trial Liner | Dia. 40mm # STD | In distribution |
| Liner | Dia. 40mm +3 | In distribution |
| 1365.54.816 | Dia. 40 mm, Retentive +3mm | In distribution |
| 9013.75.331 | 7° | In distribution |
| 9013.75.884 | Posterior 10° | In distribution |
| Reverse Trial Liner | +3 Dia. 40mm | In distribution |
| 9013.74.650 | In distribution | |
| Bone Graft Instrument Set | SMALL-R/SMALL | In distribution |
| 9013.75.342 | SMALL-R # MEDIUM | In distribution |
| 1360.54.816 | Dia. 36 mm, Retentive +3mm | In distribution |
| Glenosphere | Dia. 36 mm | In distribution |
| Bone Graft Instrument Set | In distribution | |
| 1379.59.212 | STANDARD +2 – PEG S | In distribution |
| 1379.59.300 | LARGE LOW – PEG S | In distribution |
| 1365.54.811 | Dia. 40 mm, Retentive Standard | In distribution |
| Trial Ecc. Glenosphere | Dia. 40mm | In distribution |
| 1360.54.811 | Dia. 36 mm, Retentive Standard | In distribution |
| 9013.75.347 | SMALL-R #X-LONG | In distribution |
| 9013.75.375 | 7° | In distribution |
| Eccentrical Glenosphere | Dia 40mm | 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 |
| 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
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.