Prima TT Glenoid
PRIMA TT Glenoid - Eccentrical Glenosphere with Screw Dia. 44; Medium Lateraliz. (7mm); ECC.4mm
9manufacturers in China registered for this device type
129catalogue 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) | K252352 |
| Record published | 2022-12-03 |
| Record revised | 2025-02-06 (version 6) |
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 |
|---|---|---|
| 1974.15.300 | In distribution | |
| 1975.14.820 | Dia. 28 mm; Full Wedge 20° | In distribution |
| 1975.14.653 | LONG; Dia. 11 mm; L. 25 mm | In distribution |
| 9019.75.355 | In distribution | |
| 1975.15.040 | Dia. 5 mm; L. 40 mm | In distribution |
| 1975.15.025 | Dia. 5 mm; L. 25 mm | In distribution |
| 9019.75.515 | In distribution | |
| 1975.15.045 | Dia. 5 mm; L. 45 mm | In distribution |
| 1975.15.250 | Dia. 6,5 mm; L. 50 mm | In distribution |
| 9019.75.367 | Dia. 28 mm 15°/20° | In distribution |
| 1975.14.870 | Dia. 28 mm; Full Wedge 20°X | In distribution |
| 1975.14.620 | Dia. 25 mm; Full Wedge 20° | In distribution |
| 1974.09.042 | Dia. 42 mm | In distribution |
| 1976.09.042 | Dia. 42 mm; ECC.4 mm | In distribution |
| 9019.74.605 | In distribution | |
| 8433.15.030 | Dia. 5 mm; L. 30 mm | In distribution |
| 1975.14.865 | Dia. 28 mm; Full Wedge 15°X | In distribution |
| 8433.15.050 | Dia. 5 mm; L. 50 mm | In distribution |
| 8433.15.026 | Dia. 5 mm; L. 26 mm | In distribution |
| 9019.75.320 | 20° | In distribution |
| 9019.75.652 | In distribution | |
| 9019.75.949 | In distribution | |
| 9019.75.356 | Dia. 25 mm Regular/10° | In distribution |
| 9019.75.957 | In distribution | |
| 1975.14.810 | Dia. 28 mm; Full Wedge 10° | In distribution |
| 1974.54.404 | Dia. 40; High Lateralization (9mm) | In distribution |
| 9019.75.315 | 15° | In distribution |
| 9019.75.952 | In distribution | |
| 1974.15.304 | In distribution | |
| 1975.14.656 | X-LONG; Dia. 11 mm; L. 30 mm; Full TT | In distribution |
| 8433.15.022 | Dia. 5 mm; L. 22 mm | In distribution |
| 9019.74.151 | In distribution | |
| 8433.15.038 | Dia. 5 mm; L. 38 mm | In distribution |
| 1975.14.652 | MEDIUM; Dia. 11 mm; L. 17 mm | In distribution |
| 9019.75.596 | In distribution | |
| 1974.54.402 | Dia. 40; Medium Lateralization (7mm) | In distribution |
| 1976.54.442 | Eccentrial Dia. 44; Mediuim Lateralization (7mm) | In distribution |
| 9019.75.365 | In distribution | |
| 9019.74.030 | In distribution | |
| 8433.15.046 | Dia. 5 mm; L. 46 mm | In distribution |
| 9019.74.150 | In distribution | |
| 1974.15.900 | In distribution | |
| 9019.75.955 | In distribution | |
| 9019.75.302 | Dia. 28 mm Regular | In distribution |
| 1975.15.240 | Dia. 6,5 mm; L. 40 mm | In distribution |
| 1975.15.020 | Dia. 5 mm L. 20 mm | In distribution |
| 9019.75.310 | 10° | In distribution |
| 1975.15.590 | In distribution | |
| 9019.75.622 | In distribution | |
| 9019.75.520 | In distribution | |
| 1975.15.235 | Dia. 6,5 mm; L. 35 mm | In distribution |
| 9019.75.358 | In distribution | |
| 8433.15.020 | Dia. 5 mm; L. 20 mm | In distribution |
| 9019.75.359 | In distribution | |
| 9019.75.600 | In distribution | |
| 1974.54.444 | Dia. 44; High Lateralization (9mm) | In distribution |
| 9019.75.500 | In distribution | |
| 1975.14.665 | Dia. 25 mm; Full Wedge 15°X | In distribution |
| 1975.14.510 | Dia. 25 mm; Full Wedge 10° | In distribution |
| 1976.54.444 | Eccentrial Dia. 44; High Lateralization (9mm) | In distribution |
| 1975.15.245 | Dia. 6,5 mm; L. 45 mm | In distribution |
| 1974.54.400 | Dia. 40; Low Lateralization (5mm) | In distribution |
| 9019.75.511 | In distribution | |
| 1975.14.655 | LONG; Dia. 11 mm; L. 25 mm; Full TT | In distribution |
| 9019.75.366 | Dia. 25 mm 15°/20° | In distribution |
| 9019.75.653 | In distribution | |
| 1975.15.035 | Dia. 5 mm; L. 35 mm | In distribution |
| 9019.75.615 | In distribution | |
| 1974.09.036 | Dia. 36 mm | In distribution |
| 8433.15.042 | Dia. 5 mm; L. 42 mm | In distribution |
| 9019.75.962 | In distribution | |
| 1975.15.230 | Dia. 6,5 mm; L. 30 mm | In distribution |
| 9019.75.386 | In distribution | |
| 1974.15.904 | In distribution | |
| 1975.14.654 | X-LONG; Dia. 11 mm; L. 30 mm | In distribution |
| 9019.75.951 | In distribution | |
| 9019.75.390 | In distribution | |
| 9019.75.025 | In distribution | |
| 9019.74.141 | In distribution | |
| 1975.14.800 | Dia. 28 mm; Regular | In distribution |
| 8433.15.024 | Dia. 5 mm; L. 24 mm | In distribution |
| 9019.75.593 | In distribution | |
| 9019.75.514 | In distribution | |
| 1975.15.220 | Dia. 6,5 mm L. 20 mm | In distribution |
| 9019.75.654 | In distribution | |
| 1975.14.651 | SHORT; Dia. 11 mm; L. 12 mm | In distribution |
| 9019.75.651 | In distribution | |
| 1976.09.036 | Dia. 36 mm; ECC.4 mm | In distribution |
| 9019.75.592 | In distribution | |
| 9019.75.121 | In distribution | |
| 9019.74.031 | In distribution | |
| 1976.54.440 | Eccentrial Dia. 44; Low Lateralization (5mm) | In distribution |
| 8433.15.018 | Dia. 5 mm; L. 18 mm | In distribution |
| 9019.75.357 | Dia. 28 mm Regular/10° | In distribution |
| 1974.15.902 | In distribution | |
| 9019.74.300 | In distribution | |
| 9019.75.591 | In distribution | |
| 9019.74.140 | In distribution | |
| 1975.14.815 | Dia. 28 mm; Full Wedge 15° | In distribution |
| 1975.15.050 | Dia. 5 mm; L. 50 mm | In distribution |
| 9019.75.594 | In distribution | |
| 9019.75.958 | In distribution | |
| 1975.15.030 | Dia. 5 mm; L. 30 mm | In distribution |
| 9019.75.961 | In distribution | |
| 1975.14.670 | Dia. 25 mm; Full Wedge 20°X | In distribution |
| 1976.09.040 | Dia. 40 mm; ECC.4 mm | In distribution |
| 1974.09.040 | Dia. 40 mm | In distribution |
| 9019.75.956 | In distribution | |
| 9019.75.595 | In distribution | |
| 1975.14.615 | Dia. 25 mm; Full Wedge 15° | In distribution |
| 9019.75.610 | In distribution | |
| 1975.14.515 | Dia. 25 mm; Full Wedge 15° | In distribution |
| 9019.74.142 | In distribution | |
| 9019.74.143 | In distribution | |
| 1975.14.600 | Dia. 25 mm; Regular | In distribution |
| 1975.14.500 | Dia. 25 mm; Regular | In distribution |
| 9019.75.510 | In distribution | |
| 9019.75.953 | In distribution | |
| 8433.15.034 | Dia. 5 mm; L. 34 mm | In distribution |
| 1975.15.225 | Dia. 6,5 mm; L. 25mm | In distribution |
| 9019.75.624 | In distribution | |
| 1974.15.302 | In distribution | |
| 1975.15.594 | In distribution | |
| 9019.75.954 | In distribution | |
| 1974.54.442 | Dia. 44; Medium Lateralization (7mm) | In distribution |
| 9019.74.301 | In distribution | |
| 9019.75.300 | Regular | In distribution |
| 1974.54.440 | Dia. 44; Low Lateralization (5mm) | In distribution |
| 9019.75.620 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arthrex® | Arthrex, Inc. | 297 |
| FX V135 | Fx Shoulder Solutions SAS | 131 |
| 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 |
| Perform™ Humeral System | Tornier Inc. | 74 |
Showing 12 of 232. All products under Shoulder Prosthesis, Reverse Configuration
Recalls Naming This Product
3 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Limacorporate S.p.A. | UDI-DI | 2023-08-29 | Class II | Device Design | Potential for baseplate peripheral holes to be out of specification due to a manufacturing issue, which could lead to loosening of the implant, or the screw moving from its original position. | 179 |
| Limacorporate S.p.A. | UDI-DI | 2023-05-30 | Class II | Device Design | Due to manufacturing issue, their is a potential for peripheral holes to be out of specification. | 13 units |
| Limacorporate S.p.A. | UDI-DI | 2023-05-30 | Class II | Device Design | Due to manufacturing issue, their is a potential for peripheral holes to be out of specification. | 13 units |
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.