Physica KR
PHYSICA KR (cross-linked UHMWPE with Vitamin E) - Tibial Liner #10 H. 10 mm Right
21manufacturers in China registered for this device type
152catalogue 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 | Limacorporate, Italy |
|---|---|
| FDA product code | JWH |
| Device type | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3560 |
| 510(k) | K141934 |
| Record published | 2015-08-05 |
| Record revised | 2022-03-22 (version 6) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Left Tibial Liner | #6 L | In distribution |
| 6532.54.214 | #2 H. 14 mm left | In distribution |
| 6531.54.616 | #6 H. 16 mm Right | In distribution |
| Trial Femoral Component | # 8 – R | In distribution |
| 6531.54.511 | #5 H. 11 mm Right | In distribution |
| Left Tibial Liner | #2 L | In distribution |
| Left Tibial Liner | #3 L | In distribution |
| 6531.54.420 | #4 H. 20 mm Right | In distribution |
| 6531.54.712 | #7 H. 12 mm Right | In distribution |
| Right Tibial Liner | #6 R | In distribution |
| 6531.54.216 | #2 H. 16 mm Right | In distribution |
| 6531.54.912 | #9 H. 12 mm Right | In distribution |
| 6531.54.114 | #1 H. 14 mm Right | In distribution |
| 6531.54.316 | #3 H. 16 mm Right | In distribution |
| Right Tibial Liner | #10 R | In distribution |
| Left Tibial Liner | #5 L | In distribution |
| Trial Femoral Component | # 4 – L | In distribution |
| 6532.54.216 | #2 H. 16 mm left | In distribution |
| Left Tibial Liner | #7 L | In distribution |
| Left Femoral Comp. | #9-L | In distribution |
| 6531.54.214 | #2 H. 14 mm Right | In distribution |
| Left Tibial Liner | #5 L | In distribution |
| 6531.54.220 | #2 H. 20 mm Right | In distribution |
| Right Tibial Liner | #5 R | In distribution |
| 6531.54.911 | #9 H. 11 mm Right | In distribution |
| Right Tibial Liner | #10 R | In distribution |
| Right Tibial Liner | #2 R | In distribution |
| 6531.54.312 | #3 H. 12 mm Right | In distribution |
| 6531.54.320 | #3 H. 20 mm Right | In distribution |
| 6531.54.412 | #4 H. 12 mm Right | In distribution |
| 6532.54.116 | #1 H. 16 mm left | In distribution |
| 6532.54.211 | #2 H. 11 mm left | In distribution |
| 6531.54.812 | #8 H. 12 mm Right | In distribution |
| Right Tibial Liner | #4 R | In distribution |
| Left Tibial Liner | #9 L | In distribution |
| Right Tibial Liner | #7 R | In distribution |
| 6532.54.120 | #1 H. 20 mm left | In distribution |
| 6531.54.520 | #5 H. 20 mm Right | In distribution |
| 6531.54.612 | #6 H. 12 mm Right | In distribution |
| 6531.54.916 | #9 H. 16 mm Right | In distribution |
| 6531.54.416 | #4 H. 16 mm Right | In distribution |
| 6531.54.816 | #8 H. 16 mm Right | In distribution |
| Right Tibial Liner | #10 R | In distribution |
| 6531.54.714 | #7 H. 14 mm Right | In distribution |
| 6531.54.810 | #8 H. 10 mm Right | In distribution |
| Left Tibial Liner | #4 L | In distribution |
| Right Femoral Comp. | #7-R | In distribution |
| Left Tibial Liner | #1 L | In distribution |
| Left Tibial Liner | #8 L | In distribution |
| Left Tibial Liner | #10 L | In distribution |
| Trial Femoral Component | # 1 – R | In distribution |
| 6531.54.212 | #2 H. 12 mm Right | In distribution |
| Left Tibial Liner | #10 L | In distribution |
| Right Tibial Liner | #7 R | In distribution |
| Left Tibial Liner | #1 L | In distribution |
| Left Tibial Liner | #3 L | In distribution |
| Left Tibial Liner | #2 L | In distribution |
| 6531.54.510 | #5 H. 10 mm Right | In distribution |
| Right Tibial Liner | #6 R | In distribution |
| Left Tibial Liner | #3 L | In distribution |
| Right Tibial Liner | #5 R | In distribution |
| Left Tibial Liner | #5 L | In distribution |
| 6531.54.411 | #4 H. 11 mm Right | In distribution |
| 6532.54.212 | #2 H. 12 mm left | In distribution |
| 6531.54.514 | #5 H. 14 mm Right | In distribution |
| Left Tibial Liner | #8 L | In distribution |
| 6531.54.516 | #5 H. 16 mm Right | In distribution |
| Left Tibial Liner | #6 L | In distribution |
| Left Femoral Comp. | #7-L | In distribution |
| 6532.54.111 | #1 H. 11 mm left | In distribution |
| Right Tibial Liner | #3 R | In distribution |
| Right Tibial Liner | #1 R | In distribution |
| 6531.54.311 | #3 H. 11 mm Right | In distribution |
| 6531.54.820 | #8 H. 20 mm Right | In distribution |
| 6531.54.120 | #1 H. 20 mm Right | In distribution |
| Trial Femoral Component | # 2 – L | In distribution |
| 6531.54.811 | #8 H. 11 mm Right | In distribution |
| Left Tibial Liner | #2 L | In distribution |
| Trial Femoral Component | # 10 – R | In distribution |
| 6531.54.611 | #6 H. 11 mm Right | In distribution |
| 6531.54.112 | #1 H. 12 mm Right | In distribution |
| Left Tibial Liner | #7 L | In distribution |
| Right Femoral Comp. | #5-R | In distribution |
| Right Tibial Liner | #4 R | In distribution |
| 6531.54.914 | #9 H. 14 mm Right | In distribution |
| Right Tibial Liner | #6 R | In distribution |
| 6532.54.114 | #1 H. 14 mm left | In distribution |
| Right Tibial Liner | #3 R | In distribution |
| Trial Femoral Component | # 4 – R | In distribution |
| Right Tibial Liner | #8 R | In distribution |
| 6531.54.210 | #2 H. 10 mm Right | In distribution |
| 6531.54.A10 | #10 H. 10 mm Right | In distribution |
| 6531.54.610 | #6 H. 10 mm Right | In distribution |
| 6531.54.A12 | #10 H. 12 mm Right | In distribution |
| 6531.54.920 | #9 H. 20 mm Right | In distribution |
| Trial Femoral Component | # 6 – R | In distribution |
| Left Tibial Liner | #4 L | In distribution |
| Left Tibial Liner | #1 L | In distribution |
| 6531.54.512 | #5 H. 12 mm Right | In distribution |
| Right Tibial Liner | #9 R | In distribution |
| 6531.54.310 | #3 H. 10 mm Right | In distribution |
| 6531.54.620 | #6 H. 20 mm Right | In distribution |
| Right Tibial Liner | #4 R | In distribution |
| Left Tibial Liner | #4 L | In distribution |
| Trial Femoral Component | # 10 – L | In distribution |
| 6531.54.711 | #7 H. 11 mm Right | In distribution |
| Right Tibial Liner | #8 R | In distribution |
| Left Tibial Liner | #9 L | In distribution |
| Left Tibial Liner | #6 L | In distribution |
| Left Tibial Liner | #7 L | In distribution |
| 6531.54.414 | #4 H. 14 mm Right | In distribution |
| 6531.54.111 | #1 H. 11 mm Right | In distribution |
| Left Femoral Comp. | #3-L | In distribution |
| 6531.54.110 | #1 H. 10 mm Right | In distribution |
| 6531.54.A16 | #10 H. 16 mm Right | In distribution |
| Left Tibial Liner | #10 L | In distribution |
| Right Tibial Liner | #3 R | In distribution |
| 6531.54.710 | #7 H. 10 mm Right | In distribution |
| 6532.54.112 | #1 H. 12 mm left | In distribution |
| 6531.54.720 | #7 H. 20 mm Right | In distribution |
| Right Tibial Liner | #7 R | In distribution |
| Right Tibial Liner | #1 R | In distribution |
| 6532.54.210 | #2 H. 10 mm left | In distribution |
| Right Tibial Liner | #5 R | In distribution |
| Right Tibial Liner | #2 R | In distribution |
| 6531.54.314 | #3 H. 14 mm Right | In distribution |
| Left Femoral Comp. | #5-L | In distribution |
| Left Tibial Liner | #8 L | In distribution |
| 6531.54.211 | #2 H. 11 mm Right | In distribution |
| 6531.54.814 | #8 H. 14 mm Right | In distribution |
| Left Tibial Liner | #9 L | In distribution |
| Trial Femoral Component | # 3 – R | In distribution |
| Left Femoral Comp. | #1-L | In distribution |
| 6531.54.A14 | #10 H. 14 mm Right | In distribution |
| Right Tibial Liner | #8 R | In distribution |
| 6531.54.614 | #6 H. 14 mm Right | In distribution |
| Right Femoral Comp. | #9-R | In distribution |
| Right Tibial Liner | #9 R | In distribution |
| Trial Femoral Component | # 6 – L | In distribution |
| 6531.54.910 | #9 H. 10 mm Right | In distribution |
| Right Femoral Comp. | #1-R | In distribution |
| Right Tibial Liner | #1 R | In distribution |
| 6531.54.A11 | #10 H. 11 mm Right | In distribution |
| 6531.54.716 | #7 H. 16 mm Right | In distribution |
| 6531.54.410 | #4 H. 10 mm Right | In distribution |
| 6531.54.A20 | #10 H. 20 mm Right | In distribution |
| Right Femoral Comp. | #3-R | In distribution |
| 6532.54.110 | #1 H. 10 mm left | In distribution |
| 6531.54.116 | #1 H. 16 mm Right | In distribution |
| Trial Femoral Component | # 8 – L | In distribution |
| Right Tibial Liner | #2 R | In distribution |
| Right Tibial Liner | #9 R | 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 |
|---|---|
| K211938 | 2021-07-13 |
| K190911 | 2019-11-26 |
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.