Klassic Tibial Insert, CR/Congruent, E-Link Poly
Tibial Insert, CR/Congruent, E-Link Poly, size 4, 10mm
12manufacturers in China registered for this device type
19catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (3), Zhejiang (2). 8 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 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Total Joint Orthopedics, Inc., United States |
|---|---|
| FDA product code | MBH |
| Device type | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3565 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K180159 |
| Record published | 2018-03-29 |
| Record revised | 2018-07-06 (version 2) |
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 |
|---|---|---|
| 5302.04.010 | size 4, 10mm | In distribution |
| 5302.06.012 | size 6, 12mm | In distribution |
| 5302.06.013 | size 6, 13mm | In distribution |
| 5302.03.018 | size 3, 18mm | In distribution |
| 5302.06.010 | size 6, 10mm | In distribution |
| 5302.03.016 | size 3, 16mm | In distribution |
| 5302.06.018 | size 6, 18mm | In distribution |
| 5302.02.016 | size 2, 16mm | In distribution |
| 5302.02.012 | size 2, 12mm | In distribution |
| 5302.05.012 | size 5, 12mm | In distribution |
| 5302.01.010 | size 1, 10mm | In distribution |
| 5302.01.014 | size 1, 14mm | In distribution |
| 5302.02.014 | size 2, 14mm | In distribution |
| 5302.05.014 | size 5, 14mm | In distribution |
| 5302.03.012 | size 3, 12mm | In distribution |
| 5302.01.013 | size 1, 13mm | In distribution |
| 5302.02.011 | size 2, 11mm | In distribution |
| 5302.04.014 | size 4, 14mm | In distribution |
| 5302.05.018 | size 5, 18mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Prophecy | Microport Orthopedics Inc. | 4,272 |
| Triathlon | Howmedica Osteonics Corp | 712 |
| Instrument | Howmedica Osteonics Corp | 709 |
| Persona® Vivacit-E® | Zimmer, Inc. | 499 |
| Arthrex® | Arthrex, Inc. | 494 |
| Persona® | Zimmer, Inc. | 441 |
| Legion | Smith & Nephew, Inc. | 397 |
| U2 Total Knee System | United Orthopedic Corp. | 286 |
| Attune | Depuy (Ireland) | 234 |
| DJO Surgical | Encore Medical, L.P. | 191 |
| Vanguard XP Instrumentation | Biomet Orthopedics | 150 |
| Truliant® | Exactech, Inc. | 142 |
Showing 12 of 948. All products under Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K162256 | 2016-10-27 |
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.