SLK Evo
Cruciate Sacrificing ( Posterior Stabilised) Femoral Componant for Cemented applications (Cobalt Chrome), Denoted size 55mm (Width) Anatomical Orientation - Right
21manufacturers in China registered for this device type
68catalogue numbers in this listing
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 | Implants Intl. Ltd., United Kingdom |
|---|---|
| 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, Manufacturer |
| 510(k) | K980999 |
| Record published | 2016-07-31 |
| Record revised | 2024-04-08 (version 4) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Room temperature and Dry |
| Sizes | Width 55 to 75 mm; outer diameter 32 to 38 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CR Modular (STD) Tibial insert 55mm x 11mm | Width 55 mm | In distribution |
| CS Modular (PS) Tibial insert 55mm x 15mm | Width 55 mm | In distribution |
| CS Modular (PS) Tibial insert 60mm x 11mm | Width 60 mm | In distribution |
| CR Femoral (STD) Right 55mm | Width 55 mm | In distribution |
| CR Modular (STD) Tibial insert 65mm x 11mm | Width 65 mm | In distribution |
| CR Femoral (STD) Left 55mm | Width 55 mm | In distribution |
| Patella Button 32mm | Outer Diameter 32 mm | In distribution |
| CR Modular (STD) Tibial insert 60mm x 11mm | Width 60 mm | In distribution |
| Tibial Tray Pegged (STD) 70mm | Width 70 mm | In distribution |
| CS Modular (PS) Tibial insert 65mm x 11mm | Width 65 mm | In distribution |
| CR Femoral (STD) Left 70mm | Width 70 mm | In distribution |
| CR Femoral (STD) Left 60mm | Width 60 mm | In distribution |
| CR Femoral (STD) Right 65mm | Width 65 mm | In distribution |
| Tibial Tray Pegged (STD) 65mm | Width 65 mm | In distribution |
| CS Modular (PS) Tibial insert 70mm x 7mm | Width 70 mm | In distribution |
| CS Femoral (PS) Right 70mm | Width 70 mm | In distribution |
| CR Modular (STD) Tibial insert 70mm x 9mm | Width 70 mm | In distribution |
| CS Femoral (PS) Right 60mm | Width 60 mm | In distribution |
| CR Modular (STD) Tibial insert 65mm x 7mm | Width 65 mm | In distribution |
| CR Modular (STD) Tibial insert 65mm x 15mm | Width 65 mm | In distribution |
| CR Modular (STD) Tibial insert 55mm x 13mm | Width 55 mm | In distribution |
| CS Femoral (PS) Left 65mm | Width 65 mm | In distribution |
| CS Femoral (PS) Right 65mm | Width 65 mm | In distribution |
| Tibial Tray Pegged (PLUS) 55mm | Width 60 mm | In distribution |
| CR Modular (STD) Tibial insert 70mm x 15mm | Width 70 mm | In distribution |
| CS Modular (PS) Tibial insert 65mm x 15mm | Width 65 mm | In distribution |
| CR Modular (STD) Tibial insert 65mm x 9mm | Width 65 mm | In distribution |
| CS Modular (PS) Tibial insert 60mm x 15mm | Width 60 mm | In distribution |
| Tibial Tray Pegged (STD) 55mm | Width 55 mm | In distribution |
| Tibial Tray Pegged (PLUS) 60mm | Width 65 mm | In distribution |
| CS Modular (PS) Tibial insert 70mm x 11mm | Width 70 mm | In distribution |
| CR Modular (STD) Tibial insert 70mm x 13mm | Width 70 mm | In distribution |
| CR Modular (STD) Tibial insert 55mm x 7mm | Width 55 mm | In distribution |
| Tibial Tray Pegged (PLUS) 65mm | Width 70 mm | In distribution |
| CS Femoral (PS) Left 70mm | Width 70 mm | In distribution |
| CS Femoral (PS) Left 60mm | Width 60 mm | In distribution |
| CR Modular (STD) Tibial insert 70mm x 11mm | Width 70 mm | In distribution |
| CR Modular (STD) Tibial insert 60mm x 13mm | Width 60 mm | In distribution |
| Tibial Tray Pegged (PLUS) 70mm | Width 75 mm | In distribution |
| CS Femoral (PS) Left 55mm | Width 55 mm | In distribution |
| CS Modular (PS) Tibial insert 70mm x 13mm | Width 70 mm | In distribution |
| CS Modular (PS) Tibial insert 65mm x 13mm | Width 65 mm | In distribution |
| CS Modular (PS) Tibial insert 55mm x 13mm | Width 55 mm | In distribution |
| CR Modular (STD) Tibial insert 55mm x 15mm | Width 55 mm | In distribution |
| CR Modular (STD) Tibial insert 60mm x 15mm | Width 60 mm | In distribution |
| CS Modular (PS) Tibial insert 65mm x 7mm | Width 65 mm | In distribution |
| Patella Button 36mm | Outer Diameter 36 mm | In distribution |
| Patella Button 38mm | Outer Diameter 38 mm | In distribution |
| Tibial Tray Pegged (STD) 60mm | Width 60 mm | In distribution |
| CS Modular (PS) Tibial insert 70mm x 9mm | Width 70 mm | In distribution |
| CR Femoral (STD) Right 70mm | Width 70 mm | In distribution |
| CS Modular (PS) Tibial insert 60mm x 11mm | Width 60 mm | In distribution |
| CS Modular (PS) Tibial insert 55mm x 7mm | Width 55 mm | In distribution |
| CS Modular (PS) Tibial insert 70mm x 15mm | Width 70 mm | In distribution |
| CR Modular (STD) Tibial insert 65mm x 13mm | Width 65 mm | In distribution |
| CS Modular (PS) Tibial insert 55mm x 11mm | Width 55 mm | In distribution |
| CS Femoral (PS) Right 55mm | Width 55 mm | In distribution |
| CS Modular (PS) Tibial insert 60mm x 7mm | Width 60 mm | In distribution |
| CS Modular (PS) Tibial insert 55mm x 9mm | Width 55 mm | In distribution |
| CS Modular (PS) Tibial insert 60mm x 9mm | Width 60 mm | In distribution |
| CR Modular (STD) Tibial insert 60mm x 9mm | Width 60 mm | In distribution |
| CR Modular (STD) Tibial insert 55mm x 9mm | Width 55 mm | In distribution |
| CR Modular (STD) Tibial insert 60mm x 7mm | Width 60 mm | In distribution |
| CS Modular (PS) Tibial insert 65mm x 9mm | Width 65 mm | In distribution |
| CR Femoral (STD) Right 60mm | Width 60 mm | In distribution |
| Patella Button 34mm | Outer Diameter 34 mm | In distribution |
| CR Modular (STD) Tibial insert 70mm x 7mm | Width 70 mm | In distribution |
| CR Femoral (STD) Left 65mm | Width 65 mm | 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
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.