Consensus Knee System With TiNbN
Consensus Knee System with TiNbN includes cobalt-chromium-molybdenum femoral components and tibial baseplates with a titanium-niobium-nitride surface layer. The monolayer coating covers the…
Consensus Knee System with TiNbN includes cobalt-chromium-molybdenum femoral components and tibial baseplates with a titanium-niobium-nitride surface layer. The monolayer coating covers the entire component surface and is 3 to 7 micrometres thick.
The femoral components use a cruciate-retaining RLP design in left and right versions. Tibial baseplates are offered in holed, pegged and pegless configurations.
Listed Item
CKS, Femoral Component, RLP, CR, TiNbN Coating, Right, Size 2
Component Sizes and Fixation
Femoral sizes range from 1 to 6 and tibial baseplate sizes from 0 to 6. The TiNbN-coated nonporous components are intended for cemented fixation. The coating is applied over the cast cobalt-chromium-molybdenum substrate while retaining the underlying component geometry.
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 | Shalby Advanced Technologies, Inc., United States |
|---|---|
| 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, Contract steriliser, Manufacturer |
| 510(k) | K241180 |
| Record published | 2025-02-19 |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2294-0-0001 | In distribution | |
| 2291-0-0003 | In distribution | |
| 2289-0-0003 | In distribution | |
| 2294-0-0006 | In distribution | |
| 2293-0-0002 | In distribution | |
| 2268-0-0002 | In distribution | |
| 2292-0-0000 | In distribution | |
| 2267-0-0003 | In distribution | |
| 2294-0-0002 | In distribution | |
| 2268-0-0004 | In distribution | |
| 2292-0-0005 | In distribution | |
| 2291-0-0001 | In distribution | |
| 2293-0-0005 | In distribution | |
| 2292-0-0003 | In distribution | |
| 2292-0-0002 | In distribution | |
| 2268-0-0006 | In distribution | |
| 2291-0-0006 | In distribution | |
| 2291-0-0005 | In distribution | |
| 2267-0-0002 | In distribution | |
| 2293-0-0004 | In distribution | |
| 2267-0-0004 | In distribution | |
| 2289-0-0005 | In distribution | |
| 2289-0-0004 | In distribution | |
| 2293-0-0001 | In distribution | |
| 2289-0-0001 | In distribution | |
| 2268-0-0005 | In distribution | |
| 2290-0-0002 | In distribution | |
| 2291-0-0002 | In distribution | |
| 2294-0-0005 | In distribution | |
| 2267-0-0006 | In distribution | |
| 2290-0-0003 | In distribution | |
| 2294-0-0003 | In distribution | |
| 2293-0-0003 | In distribution | |
| 2267-0-0005 | In distribution | |
| 2292-0-0006 | In distribution | |
| 2289-0-0000 | In distribution | |
| 2290-0-0000 | In distribution | |
| 2268-0-0003 | In distribution | |
| 2290-0-0005 | In distribution | |
| 2290-0-0006 | In distribution | |
| 2294-0-0000 | In distribution | |
| 2293-0-0006 | In distribution | |
| 2267-0-0001 | In distribution | |
| 2292-0-0001 | In distribution | |
| 2292-0-0004 | In distribution | |
| 2291-0-0004 | In distribution | |
| 2291-0-0000 | In distribution | |
| 2290-0-0001 | In distribution | |
| 2289-0-0002 | In distribution | |
| 2289-0-0006 | In distribution | |
| 2290-0-0004 | In distribution | |
| 2294-0-0004 | In distribution | |
| 2268-0-0001 | In distribution | |
| 2293-0-0000 | 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 |
|---|---|
| K241180 | 2025-01-14 |
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.