Tema Elbow
TEMA Elbow - Taper Breaker for Articulation Assembly Humeral
3manufacturers in China registered for this device type
90catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Limacorporate, Italy |
|---|---|
| FDA product code | JDB |
| Device type | Prosthesis, Elbow, Semi-Constrained, Cemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3160 |
| Record published | 2019-05-24 |
| Record revised | 2024-01-08 (version 4) |
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 |
|---|---|---|
| 9015.52.901 | RIGHT | In distribution |
| 9015.50.020 | Large | In distribution |
| 1590.15.010 | Small | In distribution |
| 9015.04.012 | #H12 | In distribution |
| 9015.50.200 | In distribution | |
| 9015.04.180 | #H8 – LEFT | In distribution |
| 9015.60.142 | In distribution | |
| 9015.50.301 | RIGHT | In distribution |
| 9015.50.110 | Small – LEFT | In distribution |
| 9015.75.010 | #U5 – LEFT | In distribution |
| 9015.52.005 | In distribution | |
| 9015.04.010 | #H10 | In distribution |
| 9015.04.006 | #H6 | In distribution |
| 9015.75.004 | RIGHT | In distribution |
| 9015.04.200 | #H10 – LEFT | In distribution |
| 9015.75.006 | RIGHT | In distribution |
| 9015.75.009 | #U4.5 – RIGHT | In distribution |
| 1550.15.110 | small left | In distribution |
| 1504.14.081 | H8 right | In distribution |
| 9015.90.001 | LEFT | In distribution |
| 9015.60.021 | Large – RIGHT | In distribution |
| 1575.14.020 | U5.5 | In distribution |
| 1575.14.050 | U7 | In distribution |
| 1575.14.070 | U8 | In distribution |
| 9015.52.165 | LEFT | In distribution |
| 9015.75.140 | #U6.5 | In distribution |
| 9015.50.120 | Large – LEFT | In distribution |
| 9015.02.055 | Dia. 5.5 mm | In distribution |
| 9015.75.070 | #U8 – LEFT | In distribution |
| 9015.04.051 | #H5 – RIGHT | In distribution |
| 9015.75.030 | #U6 – LEFT | In distribution |
| 9015.04.008 | #H8 | In distribution |
| 1575.14.060 | U7.5 | In distribution |
| 1575.14.040 | U6.5 | In distribution |
| 9015.04.091 | #H9 – RIGHT | In distribution |
| 9015.04.071 | #H7 – RIGHT | In distribution |
| 1552.14.020 | large left | In distribution |
| 9015.75.001 | LEFT | In distribution |
| 9015.50.005 | In distribution | |
| 9015.02.045 | Dia. 4.5 mm | In distribution |
| 9015.04.111 | #H11/12 – RIGHT | In distribution |
| 9015.90.004 | In distribution | |
| 9015.04.250 | LEFT | In distribution |
| 9015.52.141 | In distribution | |
| 9015.04.190 | #H9 – LEFT | In distribution |
| 9015.75.120 | #U5.5 | In distribution |
| 9015.52.200 | In distribution | |
| 9015.04.100 | #H10 – LEFT | In distribution |
| 1550.15.010 | small left | In distribution |
| 1504.14.070 | H7 left | In distribution |
| 1550.15.120 | large left | In distribution |
| 9015.04.160 | #H6 – LEFT | In distribution |
| 9015.04.080 | #H8 – LEFT | In distribution |
| 1550.15.121 | large right | In distribution |
| 9015.90.010 | Small | In distribution |
| 9015.75.040 | #U6.5 – LEFT | In distribution |
| 1504.14.061 | H6 right | In distribution |
| 9015.75.091 | #U9 Right | In distribution |
| 9015.60.010 | Small – LEFT | In distribution |
| 9015.75.051 | #U7 – RIGHT | In distribution |
| 9015.50.167 | In distribution | |
| 9015.50.176 | In distribution | |
| 9084.20.083 | Dia. 3,5 L. 60 mm | In distribution |
| 9015.52.002 | RIGHT | In distribution |
| 9015.75.061 | #U7.5 – RIGHT | In distribution |
| 9015.50.203 | In distribution | |
| 9015.04.170 | #H7 – LEFT | In distribution |
| 9015.75.090 | #U9 Left | In distribution |
| 1560.50.021 | large right | In distribution |
| 1552.15.900 | In distribution | |
| 9015.50.166 | RIGHT | In distribution |
| 9015.52.140 | In distribution | |
| 9015.02.001 | In distribution | |
| 9095.11.012 | In distribution | |
| 1504.14.090 | H9 left | In distribution |
| 1504.14.101 | H10 right | In distribution |
| 9015.75.021 | #U5.5 – RIGHT | In distribution |
| 9015.04.060 | #H6 – LEFT | In distribution |
| 9015.50.144 | In distribution | |
| 1590.15.020 | Large | In distribution |
| 1552.14.011 | small right | In distribution |
| 1550.15.111 | small right | In distribution |
| 9015.75.081 | #U8,5 Right | In distribution |
| 1552.14.020 | large left | In distribution |
| 9015.75.080 | #U8,5 Left | In distribution |
| 9015.90.003 | In distribution | |
| 1560.50.010 | small left | In distribution |
| 1550.15.021 | large right | In distribution |
| 9015.52.030 | LEFT | In distribution |
| 9015.52.167 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Rhead | Stryker GmbH | 46 |
| Latitude EV™ | Tornier Inc. | 33 |
| Latitude™ – Elbow | Tornier Inc. | 22 |
| UNI-Elbow | Stryker GmbH | 20 |
| Tema Elbow System | Limacorporate | 9 |
| Sorbie Questor ™ | Wright Medical Technology, Inc. | 9 |
| AMK | Depuy Orthopaedics, Inc. | 8 |
| RHS – Radial Prosthesis | Tornier Inc. | 7 |
| AML TRI-Lock | Depuy Orthopaedics, Inc. | 2 |
| Acclaim | Depuy Orthopaedics, Inc. | 2 |
| Elite | Depuy Intl., Ltd. | 1 |
| Latitude | Tornier Inc. | 1 |
Showing 12 of 18. All products under Prosthesis, Elbow, Semi-Constrained, Cemented
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 | 2024-10-02 | Class II | Process control | Due to a potential difference in mechanical behavior between the implanted device and tool(s) used during revision surgery. | ~87 devices (U.S.) |
| Limacorporate S.p.A. | UDI-DI | 2023-01-25 | Class II | Employee error | Due to the incorrect component, that is not cleared to be marketed in the U.S., being included in its elbow prosthesis. | 5 systems |
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.