Active-X Total Knee System
Active-X is a modular knee replacement with a femoral component, tibial baseplate, polyethylene meniscal insert and patellar component. The femoral part articulates against the insert,…
Active-X is a modular knee replacement with a femoral component, tibial baseplate, polyethylene meniscal insert and patellar component. The femoral part articulates against the insert, which is supported by the tibial baseplate.
The femoral component and baseplate are cast cobalt-chromium alloy. All insert variants and the patellar component are ultra-high-molecular-weight polyethylene.
Bearing and Fixation Options
Insert choices include standard, ultracongruent and ultracongruent-plus forms. The system is intended for skeletally mature patients with sufficient supporting bone stock and is designed for fixation with PMMA bone cement. These are cemented knee components.
21manufacturers in China registered for this device type
209catalogue 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) | K160159 |
| Record published | 2016-09-23 |
| 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 |
|---|---|---|
| 10-1533-0283 | In distribution | |
| 10-1533-0095 | In distribution | |
| 10-1533-0016 | In distribution | |
| 10-1533-0173 | In distribution | |
| 10-1533-0118 | In distribution | |
| 10-1533-0117 | In distribution | |
| 10-1533-0238 | In distribution | |
| 10-1533-0017 | In distribution | |
| 10-1533-0185 | In distribution | |
| 10-1533-0019 | In distribution | |
| 10-1533-0205 | In distribution | |
| 10-1533-0240 | In distribution | |
| 10-1522-0270 | In distribution | |
| 10-1522-0364 | In distribution | |
| 10-1533-0183 | In distribution | |
| 10-1533-0267 | In distribution | |
| 10-1533-0273 | In distribution | |
| 10-1533-0227 | In distribution | |
| 10-1533-0182 | In distribution | |
| 10-1533-0226 | In distribution | |
| 10-1521-0348 | In distribution | |
| 10-1533-0223 | In distribution | |
| 10-1533-0250 | In distribution | |
| 10-1533-0234 | In distribution | |
| 10-1533-0271 | In distribution | |
| 10-1533-0264 | In distribution | |
| 10-1533-0263 | In distribution | |
| 10-1533-0236 | In distribution | |
| 10-1533-0231 | In distribution | |
| 10-1533-0015 | In distribution | |
| 10-1533-0018 | In distribution | |
| 10-1533-0232 | In distribution | |
| 10-1533-0225 | In distribution | |
| 10-1533-0096 | In distribution | |
| 10-1533-0244 | In distribution | |
| 10-1533-0088 | In distribution | |
| 10-1533-0228 | In distribution | |
| 10-1533-0245 | In distribution | |
| 10-1533-0093 | In distribution | |
| 10-1533-0092 | In distribution | |
| 10-1533-0167 | In distribution | |
| 10-1513-0505 | In distribution | |
| 10-1533-0153 | In distribution | |
| 10-1533-0098 | In distribution | |
| 10-1533-0198 | In distribution | |
| 10-1533-0200 | In distribution | |
| 10-1521-0346 | In distribution | |
| 121-13-0002 | In distribution | |
| 10-1522-0365 | In distribution | |
| 10-1533-0289 | In distribution | |
| 10-1533-0265 | In distribution | |
| 10-1513-0503 | In distribution | |
| 10-1533-0116 | In distribution | |
| 10-1533-0256 | In distribution | |
| 10-1533-0190 | In distribution | |
| 10-1533-0288 | In distribution | |
| 10-1533-0259 | In distribution | |
| 10-1533-0176 | In distribution | |
| 10-1533-0221 | In distribution | |
| 10-1533-0281 | In distribution | |
| 10-1533-0177 | In distribution | |
| 10-1533-0280 | In distribution | |
| 10-1533-0104 | In distribution | |
| 10-1533-0188 | In distribution | |
| 10-1533-0181 | In distribution | |
| 10-1533-0103 | In distribution | |
| 10-1533-0172 | In distribution | |
| 10-1533-0155 | In distribution | |
| 10-1533-0193 | In distribution | |
| 10-1533-0279 | In distribution | |
| 10-1533-0168 | In distribution | |
| 10-1522-0369 | In distribution | |
| 10-1533-0251 | In distribution | |
| 10-1533-0243 | In distribution | |
| 10-1513-0506 | In distribution | |
| 10-1533-0230 | In distribution | |
| 10-1533-0083 | In distribution | |
| 10-1533-0100 | In distribution | |
| 10-1533-0249 | In distribution | |
| 10-1533-0266 | In distribution | |
| 10-1533-0277 | In distribution | |
| 10-1521-0342 | In distribution | |
| 10-1533-0162 | In distribution | |
| 10-1533-0258 | In distribution | |
| 10-1533-0270 | In distribution | |
| 10-1533-0081 | In distribution | |
| 10-1533-0156 | In distribution | |
| 10-1533-0242 | In distribution | |
| 10-1533-0186 | In distribution | |
| 10-1513-0501 | In distribution | |
| 10-1533-0114 | In distribution | |
| 10-1533-0099 | In distribution | |
| 10-1533-0187 | In distribution | |
| 10-1514-0750 | In distribution | |
| 10-1533-0246 | In distribution | |
| 10-1533-0089 | In distribution | |
| 10-1533-0094 | In distribution | |
| 10-1533-0229 | In distribution | |
| 10-1533-0161 | In distribution | |
| 10-1533-0082 | In distribution | |
| 10-1533-0247 | In distribution | |
| 10-1533-0174 | In distribution | |
| 10-1533-0169 | In distribution | |
| 121-13-0003 | In distribution | |
| 10-1513-0500 | In distribution | |
| 10-1533-0222 | In distribution | |
| 10-1521-0250 | In distribution | |
| 10-1533-0285 | In distribution | |
| 10-1533-0233 | In distribution | |
| 10-1533-0204 | In distribution | |
| 10-1533-0175 | In distribution | |
| 10-1514-0752 | In distribution | |
| 10-1533-0197 | In distribution | |
| 10-1533-0158 | In distribution | |
| 10-1533-0268 | In distribution | |
| 10-1533-0224 | In distribution | |
| 10-1522-0366 | In distribution | |
| 10-1533-0201 | In distribution | |
| 10-1533-0262 | In distribution | |
| 10-1533-0248 | In distribution | |
| 10-1533-0286 | In distribution | |
| 10-1533-0159 | In distribution | |
| 10-1533-0287 | In distribution | |
| 121-13-0005 | In distribution | |
| 10-1521-0344 | In distribution | |
| 121-13-0004 | In distribution | |
| 10-1533-0119 | In distribution | |
| 10-1521-0343 | In distribution | |
| 10-1533-0151 | In distribution | |
| 10-1533-0112 | In distribution | |
| 10-1533-0191 | In distribution | |
| 10-1533-0192 | In distribution | |
| 10-1514-0754 | In distribution | |
| 10-1533-0278 | In distribution | |
| 10-1522-0368 | In distribution | |
| 10-1522-0367 | In distribution | |
| 10-1533-0170 | In distribution | |
| 10-1533-0237 | In distribution | |
| 10-1533-0160 | In distribution | |
| 10-1513-0502 | In distribution | |
| 10-1533-0150 | In distribution | |
| 10-1533-0180 | In distribution | |
| 10-1533-0111 | In distribution | |
| 10-1533-0105 | In distribution | |
| 10-1513-0504 | In distribution | |
| 10-1522-0363 | In distribution | |
| 10-1533-0241 | In distribution | |
| 10-1533-0113 | In distribution | |
| 10-1513-0507 | In distribution | |
| 10-1533-0255 | In distribution | |
| 10-1533-0235 | In distribution | |
| 10-1533-0091 | In distribution | |
| 10-1533-0269 | In distribution | |
| 10-1533-0154 | In distribution | |
| 10-1533-0107 | In distribution | |
| 10-1533-0239 | In distribution | |
| 10-1533-0282 | In distribution | |
| 10-1533-0179 | In distribution | |
| 10-1533-0171 | In distribution | |
| 10-1533-0260 | In distribution | |
| 10-1533-0086 | In distribution | |
| 10-1533-0085 | In distribution | |
| 10-1533-0163 | In distribution | |
| 10-1533-0109 | In distribution | |
| 10-1533-0195 | In distribution | |
| 10-1521-0347 | In distribution | |
| 10-1533-0257 | In distribution | |
| 10-1513-0508 | In distribution | |
| 10-1533-0106 | In distribution | |
| 10-1533-0194 | In distribution | |
| 10-1533-0115 | In distribution | |
| 10-1533-0220 | In distribution | |
| 10-1514-0751 | In distribution | |
| 10-1533-0164 | In distribution | |
| 10-1533-0203 | In distribution | |
| 10-1514-0753 | In distribution | |
| 10-1522-0362 | In distribution | |
| 10-1533-0199 | In distribution | |
| 10-1533-0087 | In distribution | |
| 10-1533-0184 | In distribution | |
| 10-1533-0101 | In distribution | |
| 121-13-0001 | In distribution | |
| 10-1533-0275 | In distribution | |
| 10-1533-0261 | In distribution | |
| 10-1533-0189 | In distribution | |
| 10-1533-0284 | In distribution | |
| 10-1533-0097 | In distribution | |
| 10-1521-0345 | In distribution | |
| 10-1533-0202 | In distribution | |
| 10-1533-0108 | In distribution | |
| 10-1533-0102 | In distribution | |
| 10-1533-0084 | In distribution | |
| 10-1513-0509 | In distribution | |
| 10-1533-0196 | In distribution | |
| 10-1521-0349 | In distribution | |
| 10-1533-0276 | In distribution | |
| 10-1533-0274 | In distribution | |
| 10-1533-0080 | In distribution | |
| 10-1533-0157 | In distribution | |
| 10-1533-0253 | In distribution | |
| 10-1533-0252 | In distribution | |
| 10-1533-0178 | In distribution | |
| 10-1533-0272 | In distribution | |
| 10-1533-0110 | In distribution | |
| 10-1533-0090 | In distribution | |
| 10-1533-0152 | In distribution | |
| 10-1533-0254 | In distribution | |
| 10-1533-0165 | In distribution | |
| 10-1533-0166 | In distribution |
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
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2018-12-10 | Class II | Mixed-up of materials/components | Product mix up | 3 | 2020-12-14 |
| 2018-12-10 | Class II | Mixed-up of materials/components | Product mix up | 10 | 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.