Knee Instruments
Trial Hinged Tibial Insert #1 - 23 mmTrial Hinged Tibial Insert #1 - 26 mm
53manufacturers in China registered for this device type
3,944catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (24), Guangdong (7), Zhejiang (6). 29 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| B.Braun Medical (Suzhou) Co,.Ltd | Suzhou | Jiangsu | Contract manufacturer | 37 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Suzhou Jinsheng Plastic Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
Showing 12 of 53. All 53 manufacturers in China registered for Orthopedic Manual Surgical Instrument
Record
| Listed by | Medacta International SA, Switzerland |
|---|---|
| FDA product code | LXH |
| Device type | Orthopedic Manual Surgical Instrument |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Specification developer, Repacker / relabeller, Private-label distributor, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-06-18 |
| Record revised | 2025-08-19 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 02.07.10.3506 | In distribution | |
| 02.18.10.0136 | In distribution | |
| 02.18.10.1314 | In distribution | |
| 02.12.10.0327 | In distribution | |
| 02.09.10.0104 | In distribution | |
| 02.12.10.0897 | In distribution | |
| 02.18.10.0044 | In distribution | |
| 02.09.10.9034 | In distribution | |
| 02.09.10.9093 | In distribution | |
| 02.12.10.2833 | In distribution | |
| 02.09.10.0207 | In distribution | |
| 02.12.10.0715 | In distribution | |
| 02.12.10.1110 | In distribution | |
| 02.07.10.3743 | In distribution | |
| 02.07.10.0044 | In distribution | |
| 02.18.10.0162 | In distribution | |
| 02.18.10.0509 | In distribution | |
| 02.12.10.0764 | In distribution | |
| 02.07.10.3971 | In distribution | |
| 02.07.10.0785F | In distribution | |
| 02.12.10.1486 | In distribution | |
| 02.18.10.0501 | In distribution | |
| 02.07.10.0812F | In distribution | |
| 02.07.10.0786 | In distribution | |
| 02.07.10.3658 | In distribution | |
| 2.194 | In distribution | |
| 02.07.10.5314N | In distribution | |
| 02.12.10.0705 | In distribution | |
| 02.12.10.0329 | In distribution | |
| 02.09.10.0226 | In distribution | |
| 02.12.10.0494 | In distribution | |
| 11.11112 | In distribution | |
| 02.12.10.1314 | In distribution | |
| 02.18.10.0083 | In distribution | |
| 02.12.10.1988 | In distribution | |
| 02.18.10.1145 | In distribution | |
| 02.19.10.0037 | In distribution | |
| 33.22.0126 | In distribution | |
| 02.07.10.3941 | In distribution | |
| 02.06.10.0003 | In distribution | |
| 02.07.10.4743 | In distribution | |
| 02.07.10.0802F | In distribution | |
| 02.07.10.4702 | In distribution | |
| 02.07.10.9872 | In distribution | |
| 02.18.10.0190 | In distribution | |
| 02.12.10.0331 | In distribution | |
| 02.12.10.3055 | In distribution | |
| 02.19.10.0029 | In distribution | |
| 02.07.10.0802 | In distribution | |
| 02.07.10.1017 | In distribution | |
| 02.12.10.0786 | In distribution | |
| 02.18.10.1280 | In distribution | |
| 02.12.10.1117 | In distribution | |
| 02.07.10.4577 | In distribution | |
| 02.07.10.3003 | In distribution | |
| 02.07.10.4420N | In distribution | |
| 02.18.10.8004 | In distribution | |
| 02.07.10.0880 | In distribution | |
| 02.12.10.0904 | In distribution | |
| 02.07.10.9875 | In distribution | |
| 02.07.10.4658 | In distribution | |
| 02.12.10.1095 | In distribution | |
| 1.064 | In distribution | |
| 02.09.10.0210 | In distribution | |
| 02.07.10.0782F | In distribution | |
| 02.02.10.0777 | In distribution | |
| 02.09.10.9022 | In distribution | |
| 02.12.10.1235 | In distribution | |
| 02.12.10.0895 | In distribution | |
| 02.18.10.0193 | In distribution | |
| 02.07.10.3792 | In distribution | |
| 02.07.10.0827 | In distribution | |
| 02.01.10.0049 | In distribution | |
| 02.12.10.1932 | In distribution | |
| 02.18.10.0156 | In distribution | |
| 02.07.10.0203 | In distribution | |
| 02.02.10.0735 | In distribution | |
| 02.18.10.0889 | In distribution | |
| 02.12.10.0757 | In distribution | |
| 02.02.10.0557 | In distribution | |
| 02.12.10.1124 | In distribution | |
| 02.18.10.1223 | In distribution | |
| 02.07.10.0806 | In distribution | |
| 02.02.10.0204 | In distribution | |
| 02.12.10.1205 | In distribution | |
| 02.15.10.0071 | In distribution | |
| 02.07.10.9710 | In distribution | |
| 02.09.10.9016 | In distribution | |
| 2.232 | In distribution | |
| 02.07.10.8076 | In distribution | |
| 02.07.10.0739 | In distribution | |
| 02.07.10.4107 | In distribution | |
| 1.140 | In distribution | |
| 02.12.10.1062 | In distribution | |
| 02.02.10.0091 | In distribution | |
| 02.06.10.0000 | In distribution | |
| 02.18.10.0090 | In distribution | |
| 02.07.10.0832 | In distribution | |
| 02.07.10.0775 | In distribution | |
| 02.12.10.1080 | In distribution | |
| 02.12.10.1218 | In distribution | |
| 02.12.10.1780 | In distribution | |
| 02.12.10.0755 | In distribution | |
| 02.12.10.1240 | In distribution | |
| 02.07.10.1717 | In distribution | |
| 02.02.10.0175 | In distribution | |
| 02.12.10.0740 | In distribution | |
| 02.15.10.0025 | In distribution | |
| 02.15.10.0089 | In distribution | |
| 02.07.10.4053 | In distribution | |
| 02.18.10.0025 | In distribution | |
| 11.01002 | In distribution | |
| 02.07.10.9641 | In distribution | |
| 1.016 | In distribution | |
| 02.18.10.0263 | In distribution | |
| 02.07.10.0876 | In distribution | |
| 02.07.10.0023 | In distribution | |
| 02.09.10.9041 | In distribution | |
| 02.07.10.0396 | In distribution | |
| 02.07.10.8141 | In distribution | |
| 02.09.10.9045 | In distribution | |
| 02.07.10.4045 | In distribution | |
| 02.07.10.3586 | In distribution | |
| 02.02.10.0089 | In distribution | |
| 02.12.10.1174 | In distribution | |
| 02.07.10.4517N | In distribution | |
| 02.07.10.8670 | In distribution | |
| 02.07.10.3646 | In distribution | |
| 02.07.10.9707 | In distribution | |
| 02.12.10.2050 | In distribution | |
| 02.07.10.0039 | In distribution | |
| 02.18.10.1296 | In distribution | |
| 11.01173 | In distribution | |
| 02.07.10.0769 | In distribution | |
| 02.12.10.0882 | In distribution | |
| 02.12.10.1094 | In distribution | |
| 33.22.0002 | In distribution | |
| 02.12.10.1058 | In distribution | |
| 02.12.10.1057 | In distribution | |
| 02.12.10.1404 | In distribution | |
| 02.07.10.3002 | In distribution | |
| 02.07.10.4792 | In distribution | |
| 02.07.10.2104 | In distribution | |
| 02.09.10.0189 | In distribution | |
| 02.12.10.0193 | In distribution | |
| 02.07.10.0035 | In distribution | |
| 11.01017 | In distribution | |
| 02.12.10.3016 | In distribution | |
| 02.07.10.4108 | In distribution | |
| 02.18.10.1269 | In distribution | |
| 02.07.10.0094 | In distribution | |
| 02.12.10.1430 | In distribution | |
| 02.12.10.1154 | In distribution | |
| 2.633 | In distribution | |
| 02.02.10.0026 | In distribution | |
| 02.18.10.0313 | In distribution | |
| 02.07.10.4503 | In distribution | |
| 02.15.10.0033 | In distribution | |
| 33.22.0137 | In distribution | |
| 02.02.10.0151 | In distribution | |
| 02.12.10.0305 | In distribution | |
| 02.12.10.1051 | In distribution | |
| 02.18.10.1212 | In distribution | |
| 02.18.10.0155 | In distribution | |
| 02.07.10.8074 | In distribution | |
| 02.12.10.0336 | In distribution | |
| 02.07.10.0706 | In distribution | |
| 02.07.10.4012 | In distribution | |
| 02.12.10.2026 | In distribution | |
| 02.07.10.0204 | In distribution | |
| 02.07.10.3957 | In distribution | |
| 02.18.10.0020 | In distribution | |
| 02.19.10.0009 | In distribution | |
| 02.15.10.0010 | In distribution | |
| 02.07.10.0741 | In distribution | |
| 02.07.10.2218 | In distribution | |
| 02.12.10.1144 | In distribution | |
| 02.07.10.3931 | In distribution | |
| 02.07.10.9863 | In distribution | |
| 02.09.10.0150 | In distribution | |
| 02.07.10.3950 | In distribution | |
| 02.02.10.0190 | In distribution | |
| 02.07.10.9810 | In distribution | |
| 02.12.10.0160 | In distribution | |
| 02.12.10.1913 | In distribution | |
| 02.07.10.4123 | In distribution | |
| 02.15.10.0021 | In distribution | |
| 77.11.0106 | In distribution | |
| 02.07.10.0733 | In distribution | |
| 02.12.10.1383 | In distribution | |
| 02.07.10.0785 | In distribution | |
| 02.18.10.0131 | In distribution | |
| 02.12.10.0742 | In distribution | |
| 02.07.10.4317N | In distribution | |
| 02.12.10.2993 | In distribution | |
| 11.11001 | In distribution | |
| 02.07.10.9803 | In distribution | |
| 02.12.10.0595 | In distribution | |
| 02.12.10.0862 | In distribution | |
| 02.15.10.0031 | In distribution | |
| 02.07.10.4755 | In distribution | |
| 02.18.10.1323 | In distribution | |
| 02.18.10.0608 | In distribution | |
| 02.07.10.0813F | In distribution | |
| 02.12.10.2047 | In distribution | |
| 02.07.10.8266 | In distribution | |
| 02.12.10.1452 | In distribution | |
| 02.07.10.4531 | In distribution | |
| 02.07.10.9984 | In distribution | |
| 02.07.10.4599 | In distribution | |
| 02.09.10.9054 | In distribution | |
| 11.00001 | In distribution | |
| 02.07.10.9004 | In distribution | |
| 02.12.10.0126 | In distribution | |
| 02.07.10.2102 | In distribution | |
| 02.15.10.0005 | In distribution | |
| 02.07.10.8701 | In distribution | |
| 02.07.10.0038 | In distribution | |
| 02.07.10.3949 | In distribution | |
| 02.12.10.0772 | In distribution | |
| 02.07.10.0761 | In distribution | |
| 02.12.10.0801 | In distribution | |
| 02.07.10.9156 | In distribution | |
| 02.18.10.0118 | In distribution | |
| 02.12.10.2045 | In distribution | |
| 02.07.10.8264 | In distribution | |
| 33.22.0059 | In distribution | |
| 02.12.10.0926 | In distribution | |
| 02.07.10.3932 | In distribution | |
| 02.07.10.3948 | In distribution | |
| 02.12.10.0771 | In distribution | |
| 02.07.10.4783 | In distribution | |
| 02.07.10.8149 | In distribution | |
| 02.12.10.8506 | In distribution | |
| 02.07.10.8851 | In distribution | |
| 75.36.302 | In distribution | |
| 02.18.10.0388 | In distribution | |
| 02.12.10.1491 | In distribution | |
| 02.12.10.0434 | In distribution | |
| 02.18.10.1312 | In distribution | |
| 02.12.10.0803 | In distribution | |
| 02.12.10.3004 | In distribution | |
| 02.12.10.0293 | In distribution | |
| 02.12.10.1369 | In distribution | |
| 02.15.10.0020 | In distribution | |
| 02.12.10.2024 | In distribution | |
| 02.07.10.2216 | In distribution | |
| 02.07.10.0808 | In distribution | |
| 02.07.10.4695 | In distribution | |
| 02.09.10.0169 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Razek Equipamentos | Razek Equipamentos Ltda | 11,578 |
| Orthopedic Manual Surgical Instrument | Globus Medical, Inc. | 4,784 |
| Instrument | Howmedica Osteonics Corp | 4,539 |
| Orthopedic Manual Surgical Instrument | Ortho Development Corp. | 4,076 |
| Kyocera Medical Technologies, Inc. | Kyocera Medical Technologies, Inc. | 3,420 |
| Arthrex® | Arthrex, Inc. | 3,106 |
| Spine Instruments | Medacta International SA | 2,892 |
| Orthopedic Manual Surgical Instrument | Medtronic Sofamor Danek, Inc. | 2,766 |
| Hip Instruments | Medacta International SA | 1,904 |
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 1,756 |
| ReLine | Nuvasive, Inc. | 1,208 |
| Acumed | Acumed LLC | 1,177 |
Showing 12 of 9,501. All products under Orthopedic Manual Surgical Instrument
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Medacta Usa Inc | UDI-DI | 2022-04-13 | Class II | Nonconforming Material/Component | A Size 2 trial baseplate was assembled with Size 1 instrument sets. | 50 units | 2023-10-23 |
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.