Genius Total Knee System
295 catalogue numbers from 121-07-2173, listed by Signature Orthopaedics PTY Limited, Australia, under Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer. 21 manufacturers in China are registered for this product code.
21manufacturers in China registered for this device type
295catalogue numbers in this listing
10510(k) clearances naming this product code
2recalls on this code
Who Else Makes It
Concentrated in Jiangsu (10), Shanghai (4), Beijing (3). 13 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| 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 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| b-ONE Medical (Beijing) Co., Ltd. | Beijing | Beijing | Contract manufacturer | 7 |
| Changzhou Wastonortho Medical Appliance Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 5 |
Showing 12 of 21. All 21 manufacturers in China registered for Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Record
| Listed by | Signature Orthopaedics PTY Limited, Australia |
|---|---|
| FDA product code | JWH |
| Device type | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3560 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K170613 |
| Record published | 2018-02-02 |
| Record revised | 2019-12-11 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 121-07-2173 | In distribution | |
| 121-07-2174 | In distribution | |
| 121-07-2224 | In distribution | |
| 121-07-6063 | In distribution | |
| 121-07-8004 | In distribution | |
| 121-07-2226 | In distribution | |
| 121-07-2281 | In distribution | |
| 121-07-2286 | In distribution | |
| 121-07-2000 | In distribution | |
| 121-07-1062 | In distribution | |
| 121-07-2262 | In distribution | |
| 121-07-2155 | In distribution | |
| 121-07-1164 | In distribution | |
| 121-07-2132 | In distribution | |
| 121-07-2264 | In distribution | |
| 121-07-2206 | In distribution | |
| 121-07-1001 | In distribution | |
| 121-07-2083 | In distribution | |
| 121-07-8062 | In distribution | |
| 121-07-8000 | In distribution | |
| 121-07-2004 | In distribution | |
| 121-07-2251 | In distribution | |
| 121-07-2044 | In distribution | |
| 121-07-8005 | In distribution | |
| 121-07-9063 | In distribution | |
| 121-07-4003 | In distribution | |
| 121-07-2164 | In distribution | |
| 121-07-2005 | In distribution | |
| 121-07-2120 | In distribution | |
| 121-07-5005 | In distribution | |
| 121-07-2246 | In distribution | |
| 121-07-2184 | In distribution | |
| 121-07-2154 | In distribution | |
| 121-07-2166 | In distribution | |
| 121-07-2016 | In distribution | |
| 121-07-2171 | In distribution | |
| 121-07-2051 | In distribution | |
| 121-07-5064 | In distribution | |
| 121-07-5001 | In distribution | |
| 121-07-1106 | In distribution | |
| 121-07-2175 | In distribution | |
| 121-07-2232 | In distribution | |
| 121-07-2056 | In distribution | |
| 121-07-1103 | In distribution | |
| 121-07-2074 | In distribution | |
| 121-07-6001 | In distribution | |
| 121-07-9000 | In distribution | |
| 121-07-6064 | In distribution | |
| 121-07-8006 | In distribution | |
| 121-07-6006 | In distribution | |
| 121-07-2182 | In distribution | |
| 121-07-3063 | In distribution | |
| 121-07-2170 | In distribution | |
| 121-07-2231 | In distribution | |
| 121-07-5062 | In distribution | |
| 121-07-2234 | In distribution | |
| 121-07-2001 | In distribution | |
| 121-07-2035 | In distribution | |
| 121-07-2250 | In distribution | |
| 121-07-2146 | In distribution | |
| 121-07-2102 | In distribution | |
| 121-07-2133 | In distribution | |
| 121-07-2180 | In distribution | |
| 121-07-5006 | In distribution | |
| 121-07-2266 | In distribution | |
| 121-07-1105 | In distribution | |
| 121-07-2031 | In distribution | |
| 121-07-2012 | In distribution | |
| 121-07-9005 | In distribution | |
| 121-07-1166 | In distribution | |
| 121-07-2134 | In distribution | |
| 121-07-2130 | In distribution | |
| 121-07-2202 | In distribution | |
| 121-07-2215 | In distribution | |
| 121-07-3002 | In distribution | |
| 121-07-2245 | In distribution | |
| 121-07-3060 | In distribution | |
| 121-07-2071 | In distribution | |
| 121-07-9006 | In distribution | |
| 121-07-2070 | In distribution | |
| 121-07-3000 | In distribution | |
| 121-07-2220 | In distribution | |
| 121-07-7003 | In distribution | |
| 121-07-2064 | In distribution | |
| 121-07-2275 | In distribution | |
| 121-07-2063 | In distribution | |
| 121-07-2271 | In distribution | |
| 121-07-9061 | In distribution | |
| 121-07-2260 | In distribution | |
| 121-07-3064 | In distribution | |
| 121-07-2040 | In distribution | |
| 121-07-1064 | In distribution | |
| 121-07-1104 | In distribution | |
| 121-07-2122 | In distribution | |
| 121-07-2285 | In distribution | |
| 121-07-2103 | In distribution | |
| 121-07-2213 | In distribution | |
| 121-07-2043 | In distribution | |
| 121-07-2013 | In distribution | |
| 121-07-2183 | In distribution | |
| 121-07-2010 | In distribution | |
| 121-07-2141 | In distribution | |
| 121-07-4006 | In distribution | |
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| 121-07-1006 | In distribution | |
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| 121-07-2110 | In distribution | |
| 121-07-6065 | In distribution | |
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| 121-07-2223 | In distribution | |
| 121-07-6066 | In distribution | |
| 121-07-9060 | In distribution | |
| 121-07-2042 | In distribution | |
| 121-07-2086 | In distribution | |
| 121-07-2204 | In distribution | |
| 121-07-2152 | In distribution | |
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| 121-07-2112 | In distribution | |
| 121-07-2143 | In distribution | |
| 121-07-2081 | In distribution | |
| 121-07-9066 | In distribution | |
| 121-07-3061 | In distribution | |
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| 121-07-2225 | In distribution | |
| 121-07-1160 | In distribution | |
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| 121-07-1002 | In distribution | |
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| 121-07-1005 | In distribution | |
| 121-07-2172 | In distribution | |
| 121-07-2161 | In distribution | |
| 121-07-4000 | In distribution | |
| 121-07-2062 | In distribution | |
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| 121-07-2003 | In distribution | |
| 121-07-5063 | In distribution | |
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| 121-07-2210 | In distribution | |
| 121-07-1003 | In distribution | |
| 121-07-1100 | In distribution | |
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| 121-07-1101 | In distribution | |
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| 121-07-8065 | In distribution | |
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| 121-07-2011 | In distribution | |
| 121-07-2082 | In distribution | |
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| 121-07-2254 | In distribution | |
| 121-07-2002 | In distribution | |
| 121-07-2222 | In distribution | |
| 121-07-1061 | In distribution | |
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| 121-07-8001 | In distribution | |
| 121-07-2205 | In distribution | |
| 121-07-2270 | In distribution | |
| 121-07-4005 | In distribution | |
| 121-07-2242 | In distribution | |
| 121-07-4004 | In distribution | |
| 121-07-2253 | In distribution | |
| 121-07-2241 | In distribution | |
| 121-07-3003 | In distribution | |
| 121-07-2034 | In distribution | |
| 121-07-2006 | In distribution | |
| 121-07-9001 | In distribution | |
| 121-07-8066 | In distribution | |
| 121-07-2021 | In distribution | |
| 121-07-2163 | In distribution | |
| 121-07-2121 | In distribution | |
| 121-07-2201 | In distribution | |
| 121-07-2084 | In distribution | |
| 121-07-2145 | In distribution | |
| 121-07-8060 | In distribution | |
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| 121-07-2236 | In distribution | |
| 121-07-2061 | In distribution | |
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| 121-07-5065 | In distribution | |
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| 121-07-1004 | In distribution | |
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| 121-07-2185 | In distribution | |
| 121-07-1065 | In distribution | |
| 121-07-2176 | In distribution | |
| 121-07-5004 | In distribution | |
| 121-07-2221 | In distribution | |
| 121-07-2015 | In distribution | |
| 121-07-1000 | In distribution | |
| 121-07-2105 | In distribution | |
| 121-07-2014 | In distribution | |
| 121-07-2020 | In distribution | |
| 121-07-2160 | In distribution | |
| 121-07-2235 | In distribution | |
| 121-07-2280 | In distribution | |
| 121-07-2025 | In distribution |
Showing 250 of 295 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Prophecy® | Microport Orthopedics Inc. | 4,423 |
| Exult Knee Replacement System | Corentec Co., Ltd. | 1,770 |
| Freedom | Maxx Orthopedics Inc. | 1,693 |
| Legion | Smith & Nephew, Inc. | 1,534 |
| MyKnee | Medacta International SA | 1,466 |
| Journey | Smith & Nephew, Inc. | 1,339 |
| Persona® | Zimmer, Inc. | 1,254 |
| DJO Surgical | Encore Medical, L.P. | 1,131 |
| U2 Total Knee System | United Orthopedic Corp. | 1,078 |
| CKS Plus | Shalby Advanced Technologies, Inc. | 1,024 |
| Lospa Modular Knee System | Corentec Co., Ltd. | 1,020 |
| Natural-Knee® | Zimmer, Inc. | 980 |
Showing 12 of 1,175. All products under Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K240683 | 2024-09-11 |
| K223062 | 2022-11-04 |
| K222380 | 2022-10-04 |
| K220737 | 2022-04-11 |
| K190577 | 2019-11-27 |
| K181338 | 2019-01-17 |
| K181530 | 2018-10-24 |
| K180750 | 2018-04-20 |
| K170613 | 2017-07-17 |
| K160159 | 2016-09-06 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Signature Orthopaedics PTY Limited | 510(k) number | 2018-12-10 | Class II | Mixed-up of materials/components | Product mix up | 10 | 2020-12-14 |
| Signature Orthopaedics PTY Limited | 510(k) number | 2018-12-10 | Class II | Mixed-up of materials/components | Product mix up | 3 | 2020-12-14 |
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.