P.F.C.
P.F.C. Tibial Tray Fixed Bearing Modular Plus Offset 1.5 LM/RL Cemented
21manufacturers in China registered for this device type
56catalogue numbers in this listing
2510(k) clearances naming this product code
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 | Depuy (Ireland), Ireland |
|---|---|
| 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, Repacker / relabeller, Manufacturer |
| 510(k) | K241000 |
| Record published | 2015-09-24 |
| Record revised | 2024-12-09 (version 5) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 98-0137 | In distribution | |
| 86-0185 | In distribution | |
| 98-1165 | In distribution | |
| 86-0190 | In distribution | |
| 86-0189 | In distribution | |
| 86-0374 | In distribution | |
| 86-0171 | In distribution | |
| 86-0124 | In distribution | |
| 86-0179 | In distribution | |
| 98-1162 | In distribution | |
| 86-0174 | In distribution | |
| 86-0127 | In distribution | |
| 86-0175 | In distribution | |
| 86-0187 | In distribution | |
| 86-0192 | In distribution | |
| 86-0176 | In distribution | |
| 86-0376 | In distribution | |
| 86-0123 | In distribution | |
| 86-0383 | In distribution | |
| 86-0183 | In distribution | |
| 86-0379 | In distribution | |
| 98-1167 | In distribution | |
| 86-0193 | In distribution | |
| 86-0181 | In distribution | |
| 86-0382 | In distribution | |
| 86-6403 | In distribution | |
| 86-0378 | In distribution | |
| 98-1168 | In distribution | |
| 86-0182 | In distribution | |
| 86-0195 | In distribution | |
| 86-0197 | In distribution | |
| 86-0173 | In distribution | |
| 98-0135 | In distribution | |
| 98-1163 | In distribution | |
| 86-0371 | In distribution | |
| 86-0186 | In distribution | |
| 98-0133 | In distribution | |
| 86-0126 | In distribution | |
| 86-0372 | In distribution | |
| 86-6404 | In distribution | |
| 86-0125 | In distribution | |
| 98-1164 | In distribution | |
| 86-0380 | In distribution | |
| 86-0381 | In distribution | |
| 86-0178 | In distribution | |
| 86-0194 | In distribution | |
| 98-0134 | In distribution | |
| 86-0122 | In distribution | |
| 98-0132 | In distribution | |
| 86-0196 | In distribution | |
| 86-0373 | In distribution | |
| 86-0180 | In distribution | |
| 86-0188 | In distribution | |
| 98-0138 | In distribution | |
| 86-0375 | In distribution | |
| 86-0172 | 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 |
|---|---|
| K170806 | 2017-06-15 |
| K160700 | 2016-06-10 |
Recalls Naming This Product
19 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Depuy Orthopaedics, Inc. | 510(k) number | 2018-07-18 | Class II | Employee error | This unit may be missing the screw/collet Assembly | 1 | 2019-04-17 |
| Depuy Orthopaedics, Inc. | 510(k) number | 2011-06-28 | Not classified | Employee error | DePuy initiated a voluntary recall effective immediately, for one lot of P.F.C. SIGMA RD Dome Patella 3 Peg (38mm) due to packaging labels that did not correctly reflect the size of the enclosed patellar component. In the recalled lot, the | 29 | 2013-08-28 |
| Depuy Orthopaedics, Inc. | 510(k) number | 2005-05-26 | Not classified | Other | An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant. | 5 | 2005-12-02 |
| Depuy Orthopaedics, Inc. | 510(k) number | 2005-05-26 | Not classified | Other | An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant. | 10 | 2005-12-02 |
| Depuy Orthopaedics, Inc. | 510(k) number | 2005-05-26 | Not classified | Other | An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant. | 10 | 2005-12-02 |
| Depuy Orthopaedics, Inc. | 510(k) number | 2005-05-26 | Not classified | Other | An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant. | 9 | 2005-12-02 |
| Depuy Orthopaedics, Inc. | 510(k) number | 2005-05-26 | Not classified | Other | An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant. | 10 | 2005-12-02 |
| Depuy Orthopaedics, Inc. | 510(k) number | 2005-05-26 | Not classified | Other | An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant. | 10 | 2005-12-02 |
| Depuy Orthopaedics, Inc. | 510(k) number | 2005-05-26 | Not classified | Other | An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant. | 5 | 2005-12-02 |
| Depuy Orthopaedics, Inc. | 510(k) number | 2005-05-26 | Not classified | Other | An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant. | 10 | 2005-12-02 |
| Depuy Orthopaedics, Inc. | 510(k) number | 2005-05-26 | Not classified | Other | An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant. | 5 | 2005-12-02 |
| Depuy Orthopaedics, Inc. | 510(k) number | 2005-05-26 | Not classified | Other | An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant. | 5 | 2005-12-02 |
| Depuy Orthopaedics, Inc. | 510(k) number | 2005-05-26 | Not classified | Other | An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant. | 5 | 2005-12-02 |
| Depuy Orthopaedics, Inc. | 510(k) number | 2005-05-26 | Not classified | Other | An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant. | 5 | 2005-12-02 |
| Depuy Orthopaedics, Inc. | 510(k) number | 2005-05-26 | Not classified | Other | An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant. | 10 | 2005-12-02 |
| Depuy Orthopaedics, Inc. | 510(k) number | 2005-05-26 | Not classified | Other | An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant. | 5 | 2005-12-02 |
| Depuy Orthopaedics, Inc. | 510(k) number | 2005-05-26 | Not classified | Other | An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant. | 5 | 2005-12-02 |
| Depuy Orthopaedics, Inc. | 510(k) number | 2004-01-15 | Not classified | Other | Screw size included in system was incorrect | 1 unit | 2004-09-23 |
| Depuy Orthopaedics, Inc. | 510(k) number | 2003-12-22 | Not classified | Other | The collar was incorrectly etched for the R (right) and L (Left) orientation | 1 unit | 2004-09-23 |
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.