Klassic Tibial Insert, PS-Max, Std Poly
The Klassic PS-Max tibial insert is a component of the Klassic Knee System used in prosthetic knee replacement. It adds a posterior-stabilizing design option and is offered in sizes and…
The Klassic PS-Max tibial insert is a component of the Klassic Knee System used in prosthetic knee replacement. It adds a posterior-stabilizing design option and is offered in sizes and thicknesses to match patient anatomy.
The insert belongs to a system used for conditions including osteoarthritis, avascular necrosis, rheumatoid arthritis, and revision after failed knee arthroplasty. These are indications for the complete knee replacement system.
Listed Item
Tibial Insert, PS-Max, Std Poly, Size 3, 10mm
Design Assessment
Bench assessments covered femoral and tibial stability, range of motion, wear, tibial post strength and fatigue, and modular disassembly.
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) | K202740 |
| Record published | 2020-12-02 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation Sterilization |
| 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 |
|---|---|---|
| 6300.03.010 | Size 1, 10mm | In distribution |
| 6300.06.014 | Size 1, 10mm | In distribution |
| 6300.06.016 | Size 1, 10mm | In distribution |
| 6300.02.011 | Size 1, 10mm | In distribution |
| 6300.03.022 | Size 1, 10mm | In distribution |
| 6300.02.014 | Size 1, 10mm | In distribution |
| 6300.06.012 | Size 1, 10mm | In distribution |
| 6300.06.011 | Size 1, 10mm | In distribution |
| 6300.04.016 | Size 1, 10mm | In distribution |
| 6300.03.018 | Size 1, 10mm | In distribution |
| 6300.04.014 | Size 1, 10mm | In distribution |
| 6300.05.011 | Size 1, 10mm | In distribution |
| 6300.03.013 | Size 1, 10mm | In distribution |
| 6300.03.014 | Size 1, 10mm | In distribution |
| 6300.01.018 | Size 1, 10mm | In distribution |
| 6300.04.020 | Size 1, 10mm | In distribution |
| 6300.06.021 | Size 1, 10mm | In distribution |
| 6300.02.022 | Size 1, 10mm | In distribution |
| 6300.02.024 | Size 1, 10mm | In distribution |
| 6300.02.013 | Size 1, 10mm | In distribution |
| 6300.05.014 | Size 1, 10mm | In distribution |
| 6300.06.022 | Size 1, 10mm | In distribution |
| 6300.05.020 | Size 1, 10mm | In distribution |
| 6300.01.021 | Size 1, 10mm | In distribution |
| 6300.06.018 | Size 1, 10mm | In distribution |
| 6300.03.020 | Size 1, 10mm | In distribution |
| 6300.02.018 | Size 1, 10mm | In distribution |
| 6300.04.013 | Size 1, 10mm | In distribution |
| 6300.01.013 | Size 1, 10mm | In distribution |
| 6300.05.021 | Size 1, 10mm | In distribution |
| 6300.05.022 | Size 1, 10mm | In distribution |
| 6300.01.022 | Size 1, 10mm | In distribution |
| 6300.01.012 | Size 1, 10mm | In distribution |
| 6300.02.012 | Size 1, 10mm | 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.