Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Uni Tibial Tray Medial Sizing Template, Left/Right Size 2/3
6manufacturers in China registered for this device type
303catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Zhejiang (2), Jiangsu (2), Shanghai (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
Record
| Listed by | Ortho Development Corp., United States |
|---|---|
| FDA product code | HSX |
| Device type | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3520 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K211471 |
| Record published | 2021-12-24 |
| Record revised | 2022-03-22 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number, manufacturing date |
| Sizes | Height 6 to 11 mm |
| Distribution end date | 2026-01-13 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 863-6102 | Height 10 mm | In distribution |
| 862-0102 | In distribution | |
| 863-4010 | Height 10 mm | In distribution |
| 863-1006 | Height 6 mm | In distribution |
| 863-1008 | Height 8 mm | In distribution |
| 863-1011 | Height 11 mm | In distribution |
| 863-2010 | Height 10 mm | In distribution |
| 863-1071 | Height 7 mm | In distribution |
| 862-7002 | In distribution | |
| 861-1101 | In distribution | |
| 861-2702 | In distribution | |
| 862-5001 | In distribution | |
| 863-8006 | Height 6 mm | In distribution |
| 863-8082 | Height 8 mm | In distribution |
| 862-5002 | In distribution | |
| 863-5102 | Height 10 mm | In distribution |
| 863-7102 | Height 10 mm | In distribution |
| 863-2092 | Height 9 mm | In distribution |
| 863-5011 | Height 11 mm | In distribution |
| 862-2001 | In distribution | |
| 862-0101 | In distribution | |
| 863-6071 | Height 7 mm | In distribution |
| 861-2502 | In distribution | |
| 861-1202 | In distribution | |
| 863-4111 | Height 11 mm | In distribution |
| C-1764-26 | Height 6 mm | In distribution |
| 862-8002 | In distribution | |
| 862-0111 | In distribution | |
| 862-0501 | In distribution | |
| 863-5006 | Height 6 mm | In distribution |
| 861-1612 | In distribution | |
| 861-1611 | In distribution | |
| 863-3111 | Height 11 mm | In distribution |
| 863-1007 | Height 7 mm | In distribution |
| 862-7200 | In distribution | |
| C-1808-42 | In distribution | |
| 861-1511 | In distribution | |
| 863-4061 | Height 6 mm | In distribution |
| 863-4101 | Height 10 mm | In distribution |
| 863-1111 | Height 11 mm | In distribution |
| C-1755-31 | In distribution | |
| 861-2501 | In distribution | |
| 863-4072 | Height 7 mm | In distribution |
| C-1763-12 | In distribution | |
| 863-1010 | Height 10 mm | In distribution |
| 863-1102 | Height 10 mm | In distribution |
| 863-5101 | Height 10 mm | In distribution |
| 863-8061 | Height 6 mm | In distribution |
| 863-6062 | Height 6 mm | In distribution |
| 861-1402 | In distribution | |
| 863-5010 | Height 10 mm | In distribution |
| 862-6002 | In distribution | |
| 861-1311 | In distribution | |
| 862-8001 | In distribution | |
| 863-5092 | Height 9 mm | In distribution |
| C-1808-82 | In distribution | |
| 861-1601 | In distribution | |
| 863-7071 | Height 7 mm | In distribution |
| 862-5200 | In distribution | |
| 863-1082 | Height 8 mm | In distribution |
| 863-2061 | Height 6 mm | In distribution |
| C-1808-52 | In distribution | |
| C-1808-81 | In distribution | |
| 861-2701 | In distribution | |
| 863-3091 | Height 9 mm | In distribution |
| 863-3071 | Height 7 mm | In distribution |
| 863-8010 | Height 10 mm | In distribution |
| C-1808-11 | In distribution | |
| C-1764-58 | Height 8 mm | In distribution |
| 863-6009 | Height 9 mm | In distribution |
| C-1808-22 | In distribution | |
| 863-6091 | Height 9 mm | In distribution |
| 863-6082 | Height 8 mm | In distribution |
| 861-1811 | In distribution | |
| 861-2301 | In distribution | |
| C-1755-22 | In distribution | |
| 863-5071 | Height 7 mm | In distribution |
| 863-3082 | Height 8 mm | In distribution |
| C-1755-81 | In distribution | |
| 862-8200 | In distribution | |
| C-1755-42 | In distribution | |
| 863-1101 | Height 10 mm | In distribution |
| 863-7010 | Height 10 mm | In distribution |
| 863-5008 | Height 8 mm | In distribution |
| 861-1812 | In distribution | |
| C-1808-41 | In distribution | |
| 863-8111 | Height 11 mm | In distribution |
| 863-7112 | Height 11 mm | In distribution |
| 861-1711 | In distribution | |
| 861-1102 | In distribution | |
| 863-6092 | Height 9 mm | In distribution |
| 863-2071 | Height 7 mm | In distribution |
| 863-6010 | Height 10 mm | In distribution |
| 863-2008 | Height 8 mm | In distribution |
| 863-4071 | Height 7 mm | In distribution |
| 863-3010 | Height 10 mm | In distribution |
| 863-2112 | Height 11 mm | In distribution |
| 863-5082 | Height 8 mm | In distribution |
| 863-1081 | Height 8 mm | In distribution |
| C-1764-56 | Height 6 mm | In distribution |
| 862-2100 | In distribution | |
| 861-1201 | In distribution | |
| 863-4102 | Height 10 mm | In distribution |
| 863-2091 | Height 9 mm | In distribution |
| 863-7008 | Height 8 mm | In distribution |
| 863-4092 | Height 9 mm | In distribution |
| 863-4007 | Height 7 mm | In distribution |
| 863-2006 | Height 6 mm | In distribution |
| 862-7100 | In distribution | |
| 861-1502 | In distribution | |
| C-1755-32 | In distribution | |
| 863-7082 | Height 8 mm | In distribution |
| 863-7092 | Height 9 mm | In distribution |
| C-1755-72 | In distribution | |
| C-1808-32 | In distribution | |
| 861-2601 | In distribution | |
| C-1764-46 | Height 6 mm | In distribution |
| C-1755-71 | In distribution | |
| C-1763-25 | In distribution | |
| 862-7001 | In distribution | |
| C-1808-72 | In distribution | |
| 862-4200 | In distribution | |
| 863-2111 | Height 11 mm | In distribution |
| C-1755-41 | In distribution | |
| C-1764-36 | Height 6 mm | In distribution |
| 863-3011 | Height 11 mm | In distribution |
| 862-1100 | In distribution | |
| 863-6081 | Height 8 mm | In distribution |
| 863-4011 | Height 11 mm | In distribution |
| 861-1111 | In distribution | |
| 862-0115 | In distribution | |
| 863-5111 | Height 11 mm | In distribution |
| 862-0112 | In distribution | |
| 863-2009 | Height 9 mm | In distribution |
| 863-8007 | Height 7 mm | In distribution |
| 863-6111 | Height 11 mm | In distribution |
| 862-1001 | In distribution | |
| 863-1072 | Height 7 mm | In distribution |
| 863-8101 | Height 10 mm | In distribution |
| 862-0056 | In distribution | |
| 863-6112 | Height 11 mm | In distribution |
| 862-3200 | In distribution | |
| 863-2081 | Height 8 mm | In distribution |
| 863-3061 | Height 6 mm | In distribution |
| 861-1701 | In distribution | |
| 863-3006 | Height 6 mm | In distribution |
| 861-1712 | In distribution | |
| 863-8008 | Height 8 mm | In distribution |
| 861-2201 | In distribution | |
| 862-3001 | In distribution | |
| 863-8062 | Height 6 mm | In distribution |
| 863-5009 | Height 9 mm | In distribution |
| 862-3002 | In distribution | |
| 863-5072 | Height 7 mm | In distribution |
| 863-4082 | Height 8 mm | In distribution |
| 863-2007 | Height 7 mm | In distribution |
| 861-2302 | In distribution | |
| C-1764-38 | Height 8 mm | In distribution |
| 863-3062 | Height 6 mm | In distribution |
| 863-5112 | Height 11 mm | In distribution |
| 861-1302 | In distribution | |
| 863-7011 | Height 11 mm | In distribution |
| 862-2002 | In distribution | |
| 862-1002 | In distribution | |
| 863-1092 | Height 9 mm | In distribution |
| 862-0104 | In distribution | |
| 862-0113 | In distribution | |
| 861-1702 | In distribution | |
| 861-1801 | In distribution | |
| C-1764-37 | Height 7 mm | In distribution |
| 863-7101 | Height 10 mm | In distribution |
| 863-8112 | Height 11 mm | In distribution |
| 863-8009 | Height 9 mm | In distribution |
| 863-2062 | Height 6 mm | In distribution |
| 863-7072 | Height 7 mm | In distribution |
| 863-3007 | Height 7 mm | In distribution |
| 863-3101 | Height 10 mm | In distribution |
| 861-2101 | In distribution | |
| 863-6072 | Height 7 mm | In distribution |
| 862-0103 | In distribution | |
| 862-1200 | In distribution | |
| C-1755-12 | In distribution | |
| 863-4008 | Height 8 mm | In distribution |
| C-1764-48 | Height 8 mm | In distribution |
| 861-1412 | In distribution | |
| C-1755-21 | In distribution | |
| 863-7006 | Height 6 mm | In distribution |
| 861-2401 | In distribution | |
| 863-2072 | Height 7 mm | In distribution |
| 861-2801 | In distribution | |
| 863-1062 | Height 6 mm | In distribution |
| C-1808-51 | In distribution | |
| 863-8092 | Height 9 mm | In distribution |
| 863-7111 | Height 11 mm | In distribution |
| 862-6001 | In distribution | |
| 862-0500 | In distribution | |
| 863-1009 | Height 9 mm | In distribution |
| C-1764-27 | Height 7 mm | In distribution |
| 863-2082 | Height 8 mm | In distribution |
| 861-1211 | In distribution | |
| 863-8011 | Height 11 mm | In distribution |
| 861-1501 | In distribution | |
| 863-8072 | Height 7 mm | In distribution |
| 863-7007 | Height 7 mm | In distribution |
| 861-1411 | In distribution | |
| C-1763-24 | In distribution | |
| 863-6011 | Height 11 mm | In distribution |
| 861-2102 | In distribution | |
| C-1755-82 | In distribution | |
| 863-4009 | Height 9 mm | In distribution |
| 863-3102 | Height 10 mm | In distribution |
| 861-2602 | In distribution | |
| 863-8102 | Height 10 mm | In distribution |
| 863-7061 | Height 6 mm | In distribution |
| 863-3112 | Height 11 mm | In distribution |
| 862-8100 | In distribution | |
| 863-8091 | Height 9 mm | In distribution |
| C-1755-62 | In distribution | |
| 863-8081 | Height 8 mm | In distribution |
| 862-4002 | In distribution | |
| 863-6006 | Height 6 mm | In distribution |
| 861-1312 | In distribution | |
| C-1755-61 | In distribution | |
| C-1764-57 | Height 7 mm | In distribution |
| 863-4112 | Height 11 mm | In distribution |
| 863-3081 | Height 8 mm | In distribution |
| 861-2402 | In distribution | |
| C-1808-31 | In distribution | |
| C-1764-47 | Height 7 mm | In distribution |
| 861-2202 | In distribution | |
| C-1808-71 | In distribution | |
| 863-2011 | Height 11 mm | In distribution |
| C-1755-51 | In distribution | |
| 863-5007 | Height 7 mm | In distribution |
| 862-4001 | In distribution | |
| 863-6101 | Height 10 mm | In distribution |
| 861-2802 | In distribution | |
| 862-0114 | In distribution | |
| 863-1112 | Height 11 mm | In distribution |
| 863-7062 | Height 6 mm | In distribution |
| 863-4081 | Height 8 mm | In distribution |
| 861-1512 | In distribution | |
| 861-1112 | In distribution | |
| 863-4006 | Height 6 mm | In distribution |
| 863-5081 | Height 8 mm | In distribution |
| 862-6200 | In distribution | |
| 862-4100 | In distribution | |
| 863-7091 | Height 9 mm | In distribution |
| C-1808-62 | In distribution | |
| 863-6008 | Height 8 mm | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Journey | Smith & Nephew, Inc. | 517 |
| BKS® Uni | Ortho Development Corp. | 240 |
| LinkSymphoKnee | Waldemar Link GmbH & Co. KG | 210 |
| Moto Partial Knee System | Medacta International SA | 205 |
| Arthrex® | Arthrex, Inc. | 199 |
| Stride | Smith & Nephew, Inc. | 190 |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | Zimmer, Inc. | 175 |
| ZUK | Smith & Nephew, Inc. | 161 |
| Tahoe Uni Knee System | Shalby Advanced Technologies, Inc. | 134 |
| Moto Partial Knee System – Medial | Medacta International SA | 132 |
| Journey II | Smith & Nephew, Inc. | 119 |
| Genesis | Smith & Nephew, Inc. | 118 |
Showing 12 of 171. All products under Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K211471 | 2021-12-16 |
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.