Physica KR
PHYSICA KR (cross-linked UHMWPE with Vitamin E) - Tibial Liner #10 H. 12 mm left
10manufacturers in China registered for this device type
128catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (2), Zhejiang (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| 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 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| 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 |
| Suzhou Microport Orthorecon Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 31 |
Record
| Listed by | Limacorporate, Italy |
|---|---|
| FDA product code | HRY |
| Device type | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3530 |
| 510(k) | K141934 |
| Record published | 2020-12-23 |
| 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 |
|---|---|---|
| 6532.54.914 | #9 H. 14 mm left | In distribution |
| Right Femoral Comp. | #2-R | In distribution |
| 6532.54.316 | #3 H. 16 mm left | In distribution |
| Left Tibial Liner | #7 L | In distribution |
| Left Tibial Liner | #4 L | In distribution |
| Right Tibial Liner | #7 R | In distribution |
| Right Tibial Liner | #3 R | In distribution |
| Left Femoral Comp. | #8-L | In distribution |
| Left Tibial Liner | #6 L | In distribution |
| Left Tibial Liner | #5 L | In distribution |
| Left Tibial Liner | #10 L | In distribution |
| Trial Femoral Component | # 3 – L | In distribution |
| 6532.54.516 | #5 H. 16 mm left | In distribution |
| 6532.54.820 | #8 H. 20 mm left | In distribution |
| 6532.54.A12 | #10 H. 12 mm left | In distribution |
| 6532.54.812 | #8 H. 12 mm left | In distribution |
| 6532.54.711 | #7 H. 11 mm left | In distribution |
| Left Tibial Liner | #4 L | In distribution |
| Trial Femoral Component | # 7 – R | In distribution |
| Left Tibial Liner | #3 L | In distribution |
| 6532.54.916 | #9 H. 16 mm left | In distribution |
| Right Tibial Liner | #10 R | In distribution |
| Left Tibial Liner | #7 L | In distribution |
| 6532.54.720 | #7 H. 20 mm left | In distribution |
| 6532.54.614 | #6 H. 14 mm left | In distribution |
| Right Tibial Liner | #10 R | In distribution |
| Right Tibial Liner | #2 R | In distribution |
| 6532.54.810 | #8 H. 10 mm left | In distribution |
| Right Tibial Liner | #7 R | In distribution |
| Right Tibial Liner | #4 R | In distribution |
| Right Tibial Liner | #3 R | In distribution |
| 6532.54.510 | #5 H. 10 mm left | In distribution |
| 6532.54.610 | #6 H. 10 mm left | In distribution |
| Left Tibial Liner | #8 L | In distribution |
| Left Tibial Liner | #6 L | In distribution |
| 6532.54.514 | #5 H. 14 mm left | In distribution |
| Right Tibial Liner | #6 R | In distribution |
| 6532.54.311 | #3 H. 11 mm left | In distribution |
| 6532.54.312 | #3 H. 12 mm left | In distribution |
| Left Tibial Liner | #5 L | In distribution |
| Right Tibial Liner | #9 R | In distribution |
| 6532.54.811 | #8 H. 11 mm left | In distribution |
| Trial Femoral Component | # 9 – R | In distribution |
| Left Tibial Liner | #1 L | In distribution |
| 6532.54.A16 | #10 H. 16 mm left | In distribution |
| Right Femoral Comp. | #8-R | In distribution |
| 6532.54.511 | #5 H. 11 mm left | In distribution |
| Left Tibial Liner | #8 L | In distribution |
| Left Tibial Liner | #3 L | In distribution |
| Left Tibial Liner | #5 L | In distribution |
| Left Tibial Liner | #3 L | In distribution |
| 6532.54.512 | #5 H. 12 mm left | In distribution |
| Left Femoral Comp. | #6-L | In distribution |
| 6532.54.912 | #9 H. 12 mm left | In distribution |
| Right Tibial Liner | #6 R | In distribution |
| 6532.54.414 | #4 H. 14 mm left | In distribution |
| Left Tibial Liner | #1 L | In distribution |
| Left Tibial Liner | #2 L | In distribution |
| 6532.54.920 | #9 H. 20 mm left | In distribution |
| 6532.54.714 | #7 H. 14 mm left | In distribution |
| 6532.54.412 | #4 H. 12 mm left | In distribution |
| Right Femoral Comp. | #6-R | In distribution |
| Trial Femoral Component | # 2 – R | In distribution |
| Left Tibial Liner | #2 L | In distribution |
| 6532.54.612 | #6 H. 12 mm left | In distribution |
| 6532.54.310 | #3 H. 10 mm left | In distribution |
| 6532.54.220 | #2 H. 20 mm left | In distribution |
| 6532.54.320 | #3 H. 20 mm left | In distribution |
| Right Tibial Liner | #4 R | In distribution |
| Right Tibial Liner | #5 R | In distribution |
| Trial Femoral Component | # 9 – L | In distribution |
| Trial Femoral Component | # 1 – L | In distribution |
| 6532.54.620 | #6 H. 20 mm left | In distribution |
| Left Tibial Liner | #2 L | In distribution |
| Right Tibial Liner | #5 R | In distribution |
| 6532.54.520 | #5 H. 20 mm left | In distribution |
| Trial Femoral Component | # 7 – L | In distribution |
| 6532.54.410 | #4 H. 10 mm left | In distribution |
| 6532.54.710 | #7 H. 10 mm left | In distribution |
| 6532.54.A10 | #10 H. 10 mm left | In distribution |
| Right Tibial Liner | #4 R | In distribution |
| 6532.54.716 | #7 H. 16 mm left | In distribution |
| Right Tibial Liner | #5 R | In distribution |
| Trial Femoral Component | # 5 – L | In distribution |
| Left Femoral Comp. | #4-L | In distribution |
| Right Tibial Liner | #2 R | In distribution |
| Left Femoral Comp. | #10-L | In distribution |
| Right Femoral Comp. | #4-R | In distribution |
| Trial Femoral Component | # 5 – R | In distribution |
| Right Tibial Liner | #3 R | In distribution |
| 6532.54.420 | #4 H. 20 mm left | In distribution |
| 6532.54.416 | #4 H. 16 mm left | In distribution |
| Left Tibial Liner | #4 L | In distribution |
| 6532.54.611 | #6 H. 11 mm left | In distribution |
| 6532.54.814 | #8 H. 14 mm left | In distribution |
| Right Tibial Liner | #10 R | In distribution |
| 6532.54.712 | #7 H. 12 mm left | In distribution |
| 6532.54.910 | #9 H. 10 mm left | In distribution |
| Right Tibial Liner | #8 R | In distribution |
| Right Tibial Liner | #7 R | In distribution |
| Left Tibial Liner | #9 L | In distribution |
| 6532.54.911 | #9 H. 11 mm left | In distribution |
| Right Tibial Liner | #1 R | In distribution |
| Right Tibial Liner | #9 R | In distribution |
| 6532.54.411 | #4 H. 11 mm left | In distribution |
| 6532.54.A14 | #10 H. 14 mm left | In distribution |
| 6532.54.A11 | #10 H. 11 mm left | In distribution |
| Right Tibial Liner | #9 R | In distribution |
| 6532.54.816 | #8 H. 16 mm left | In distribution |
| Left Tibial Liner | #1 L | In distribution |
| Left Tibial Liner | #8 L | In distribution |
| 6532.54.616 | #6 H. 16 mm left | In distribution |
| Left Tibial Liner | #6 L | In distribution |
| Right Tibial Liner | #6 R | In distribution |
| Left Femoral Comp. | #2-L | In distribution |
| Left Tibial Liner | #10 L | In distribution |
| Right Tibial Liner | #8 R | In distribution |
| Left Tibial Liner | #9 L | In distribution |
| Left Tibial Liner | #7 L | In distribution |
| 6532.54.A20 | #10 H. 20 mm left | In distribution |
| Left Tibial Liner | #9 L | In distribution |
| Right Tibial Liner | #1 R | In distribution |
| Right Tibial Liner | #1 R | In distribution |
| Left Tibial Liner | #10 L | In distribution |
| 6532.54.314 | #3 H. 14 mm left | In distribution |
| Right Femoral Comp. | #10-R | In distribution |
| Right Tibial Liner | #2 R | In distribution |
| Right Tibial Liner | #8 R | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Legion | Smith & Nephew, Inc. | 1,682 |
| Genesis II | Smith & Nephew, Inc. | 615 |
| Journey II | Smith & Nephew, Inc. | 581 |
| Evolution | Microport Orthopedics Inc. | 311 |
| Profix | Smith & Nephew, Inc. | 293 |
| Journey | Smith & Nephew, Inc. | 215 |
| LinkSymphoKnee | Waldemar Link GmbH & Co. KG | 201 |
| Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | Smith & Nephew, Inc. | 160 |
| JII | Smith & Nephew, Inc. | 141 |
| Physica LMC | Limacorporate | 120 |
| Implant Partners | Microport Orthopedics Inc. | 119 |
| Restoris | Mako Surgical Corp. | 118 |
Showing 12 of 160. All products under Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P840049 | 1988-09-30 | P.C.A.(TM) TOTAL KNEE SYSTEM | Howmedica Corp. |
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.