KneeTec PFJ
KneeTec PFJ Patella implant Extra-Extra Small
7manufacturers in China registered for this device type
49catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (2), Zhejiang (2). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| 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 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
Record
| Listed by | Corin Limited, United Kingdom |
|---|---|
| FDA product code | KRR |
| Device type | Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3540 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2018-08-28 |
| Record revised | 2023-05-03 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MDI392 | In distribution | |
| MDI399 | In distribution | |
| MDI411 | In distribution | |
| MDI397 | In distribution | |
| MDI403 | In distribution | |
| GDI404 | In distribution | |
| MDI481 | In distribution | |
| MDI474 | In distribution | |
| GDI413 | In distribution | |
| MDI427 | In distribution | |
| MDI404 | In distribution | |
| MDI484 | In distribution | |
| MDI425 | In distribution | |
| MDI393 | In distribution | |
| MDI386 | In distribution | |
| GDI411 | In distribution | |
| GDI403 | In distribution | |
| MDU730 | In distribution | |
| MDI424 | In distribution | |
| MDI493 | In distribution | |
| GDI401 | In distribution | |
| MDI483 | In distribution | |
| GDI414 | In distribution | |
| MDI387 | In distribution | |
| GDI402 | In distribution | |
| MDI396 | In distribution | |
| MDI413 | In distribution | |
| GDI119 | In distribution | |
| MDI390 | In distribution | |
| MDI394 | In distribution | |
| MDI398 | In distribution | |
| MDI491 | In distribution | |
| MDI412 | In distribution | |
| MDI402 | In distribution | |
| MDI423 | In distribution | |
| MDI420 | In distribution | |
| MDI395 | In distribution | |
| MDI414 | In distribution | |
| MDI490 | In distribution | |
| GDI412 | In distribution | |
| MDI482 | In distribution | |
| MDI421 | In distribution | |
| MDI391 | In distribution | |
| MDI471 | In distribution | |
| MDI473 | In distribution | |
| MDI401 | In distribution | |
| MDI492 | In distribution | |
| MDI472 | In distribution | |
| MDI422 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arthrex® | Arthrex, Inc. | 103 |
| Restoris | Mako Surgical Corp. | 76 |
| Prelude Patello-Femoral System | Biomet Orthopedics | 61 |
| Prelude PF | Biomet Orthopedics | 59 |
| HemiCAP® | Arthrosurface, Inc. | 48 |
| Instrument | Howmedica Osteonics Corp | 48 |
| Triathlon | Howmedica Osteonics Corp | 23 |
| Prelude PF | Biomet Sports Medicine | 21 |
| WaveKahuna™ | Arthrosurface, Inc. | 16 |
| HemiCAPWAVE® | Arthrosurface, Inc. | 16 |
| Sigma | Depuy (Ireland) | 16 |
| Restoris Esyntial | Mako Surgical Corp. | 14 |
Showing 12 of 47. All products under Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, 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.