Prima
PRIMA - Reverse Insert # MEDIUM Dia. 44mm 0°Corr. +3mm ECC
9manufacturers in China registered for this device type
74catalogue 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 | 2024-03-12 |
| Record revised | 2024-03-18 (version 3) |
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 |
|---|---|---|
| 1357.14.328 | #1 (+30 mm) | In distribution |
| 1367.09.503 | # MEDIUM Dia. 44mm 0°Corr. +3mm ECC | In distribution |
| 1367.54.270 | # SHORT Dia.40mm 7°Corr. | In distribution |
| 1357.14.036 | #5 | In distribution |
| 1367.15.700 | In distribution | |
| 1367.54.374 | # MEDIUM Dia.42mm 7° Corr.RETENTIVE | In distribution |
| 1367.54.200 | # SHORT Dia.40mm 0° Corr | In distribution |
| 1367.54.101 | # SHORT Dia.36mm 0° Corr.RETENTIVE | In distribution |
| 1367.15.013 | # MEDIUM | In distribution |
| 1367.09.276 | # LONG Dia. 40mm 7°Corr. | In distribution |
| 9013.67.437 | #6-7 Plus | In distribution |
| 1357.14.338 | #6 (+30 mm) | In distribution |
| 1367.54.274 | # MEDIUM Dia.40mm 7° Corr.RETENTIVE | In distribution |
| 1367.09.270 | # SHORT Dia. 40mm 7°Corr. | In distribution |
| 1367.54.104 | # MEDIUM Dia.36mm 0° Corr.RETENTIVE | In distribution |
| 1357.14.234 | #4 | In distribution |
| 1367.54.271 | # SHORT Dia.40mm 7° Corr.RETENTIVE | In distribution |
| 1367.54.371 | # SHORT Dia.42mm 7° Corr.RETENTIVE | In distribution |
| 9013.67.438 | #1-5 Plus (+30mm) | In distribution |
| 1367.09.376 | # LONG Dia. 44mm 7°Corr. | In distribution |
| 1367.54.171 | # SHORT Dia.36mm 7° Corr.RETENTIVE | In distribution |
| 1367.54.100 | # SHORT Dia.36mm 0° Corr. | In distribution |
| 1367.54.174 | # MEDIUM Dia.36mm 0° Corr.RETENTIVE | In distribution |
| 1367.54.203 | # MEDIUM Dia.40mm 0° Corr. | In distribution |
| 1357.14.330 | #2 (+30 mm) | In distribution |
| 9013.67.616 | #6 | In distribution |
| 1367.54.300 | # SHORT Dia.42mm 0° Corr. | In distribution |
| 1367.54.370 | # SHORT Dia.42mm 7° Corr | In distribution |
| 1357.14.034 | #4 | In distribution |
| 1367.54.170 | # SHORT Dia.36mm 7°Corr. | In distribution |
| 1367.54.301 | # SHORT Dia.42mm 0° Corr.RETENTIVE | In distribution |
| 1367.54.201 | # SHORT Dia.40mm 0° Corr.RETENTIVE | In distribution |
| 1357.14.332 | #3 (+30 mm) | In distribution |
| 1367.09.306 | # LONG Dia. 44mm 0°Corr. | In distribution |
| 1357.14.028 | #1 | In distribution |
| 1367.09.506 | # LONG Dia. 44mm 0°Corr. +3mm ECC | In distribution |
| 1367.09.303 | # MEDIUM Dia. 44mm 0°Corr. | In distribution |
| 1357.14.230 | #2 | In distribution |
| 9013.67.167 | #7 | In distribution |
| 1367.15.010 | # SHORT | In distribution |
| 1357.14.032 | #3 | In distribution |
| 1367.15.702 | 2 mm | In distribution |
| 1357.14.336 | #5 (+30 mm) | In distribution |
| 1357.14.232 | #3 | In distribution |
| 1367.54.373 | # MEDIUM Dia.42mm 7° Corr | In distribution |
| 9013.67.617 | #7 | In distribution |
| 1367.09.206 | # LONG Dia. 40mm 0°Corr. | In distribution |
| 1367.15.704 | 4 mm | In distribution |
| 1367.09.370 | # SHORT Dia. 44mm 7°Corr. | In distribution |
| 1367.15.706 | 6 mm | In distribution |
| 1357.14.238 | #6 | In distribution |
| 1357.14.236 | #5 | In distribution |
| 1367.09.300 | # SHORT Dia. 44mm 0°Corr. | In distribution |
| 1357.14.040 | #7 | In distribution |
| 1367.09.403 | # MEDIUM Dia. 40mm 0°Corr. +3mm ECC | In distribution |
| 1367.54.273 | # MEDIUM Dia.40mm 7° Corr. | In distribution |
| 1367.09.373 | # MEDIUM Dia. 44mm 7°Corr. | In distribution |
| 9013.67.166 | #6 | In distribution |
| 1367.54.304 | # MEDIUM Dia.42mm 0° Corr.RETENTIVE | In distribution |
| 1367.54.173 | # MEDIUM Dia.36mm 7° Corr. | In distribution |
| 9013.67.439 | #6-7 Plus (+30mm) | In distribution |
| 1367.09.406 | # LONG Dia. 40mm 0°Corr. +3mm ECC | In distribution |
| 1367.09.200 | # SHORT Dia. 40mm 0°Corr. | In distribution |
| 1367.09.203 | # MEDIUM Dia. 40mm 0°Corr. | In distribution |
| 1367.54.103 | # MEDIUM Dia.36mm 0° Corr. | In distribution |
| 1357.14.240 | #7 | In distribution |
| 1367.09.273 | # MEDIUM Dia. 40mm 7°Corr. | In distribution |
| 1357.14.340 | #7 (+30 mm) | In distribution |
| 1357.14.228 | #1 | In distribution |
| 1367.54.303 | # MEDIUM Dia.42mm 0° Corr | In distribution |
| 1367.54.204 | # MEDIUM Dia.40mm 0° Corr.RETENTIVE | In distribution |
| 1357.14.038 | #6 | In distribution |
| 1357.14.334 | #4 (+30 mm) | In distribution |
| 1357.14.030 | #2 | 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 UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Limacorporate S.p.A. | UDI-DI | 2025-05-19 | Class II | Process design | There is the potential that the eccentrical adaptor with screw, black laser marking, use to identify the position may be missing. | 19 units |
| Limacorporate S.p.A. | UDI-DI | 2025-05-19 | Class II | Process design | There is the potential that the eccentrical adaptor with screw, black laser marking, use to identify the position may be missing. | 9 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.