Klassic Tibial Insert, PS-Post, E-Link
The Klassic PS-Post E-Link Tibial Insert is a component of the Klassic total knee replacement system. It is used with the system’s posterior-stabilising femoral component as part of…
The Klassic PS-Post E-Link Tibial Insert is a component of the Klassic total knee replacement system. It is used with the system’s posterior-stabilising femoral component as part of prosthetic replacement for degenerative or inflammatory joint disease, failed previous surgery or revision of a failed knee replacement.
The insert provides the tibial-side component in the PS-Post configuration. It is available in multiple sizes and thicknesses to match patient anatomy, including the listed size 3, 11 mm configuration.
Listed Item
Tibial Insert, PS-Post, E-Link, Size 3, 11mm
System Compatibility
This insert is the E-Link Poly version identified in the PS-Post system addition. Its use follows the compatible Klassic knee construct; the primary system indication specifies cemented use except for the separately identified porous femur and porous baseplate.
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 | Total Joint Orthopedics, 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 | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K183596 |
| Record published | 2019-04-16 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: The Klassic Knee System should be stored in a clean, dry location at room temperature |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5305.03.011 | Size 6, 16mm | In distribution |
| 5305.05.016 | Size 6, 16mm | In distribution |
| 5305.03.013 | Size 6, 16mm | In distribution |
| 5305.05.011 | Size 6, 16mm | In distribution |
| 5305.06.010 | Size 6, 16mm | In distribution |
| 5305.06.012 | Size 6, 16mm | In distribution |
| 5305.01.013 | Size 6, 16mm | In distribution |
| 5305.04.013 | Size 6, 16mm | In distribution |
| 5305.02.012 | Size 6, 16mm | In distribution |
| 5305.06.016 | Size 6, 16mm | In distribution |
| 5305.02.014 | Size 6, 16mm | In distribution |
| 5305.01.011 | Size 6, 16mm | In distribution |
| 5305.01.012 | Size 6, 16mm | In distribution |
| 5305.06.011 | Size 6, 16mm | In distribution |
| 5305.01.016 | Size 6, 16mm | In distribution |
| 5305.04.016 | Size 6, 16mm | In distribution |
| 5305.01.014 | Size 6, 16mm | 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 |
|---|---|
| K261734 | 2026-07-23 |
| K211877 | 2022-06-22 |
| K211602 | 2021-07-23 |
| K202740 | 2020-10-09 |
| K183596 | 2019-03-29 |
| K190280 | 2019-03-15 |
| K180159 | 2018-03-09 |
| K162422 | 2016-10-28 |
| K153310 | 2015-12-17 |
| K153075 | 2015-11-13 |
| K150105 | 2015-02-17 |
| K140942 | 2014-05-16 |
| K112906 | 2012-02-01 |
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.