Physica LMC
PHYSICA LMC (cross-linked UHMWPE with Vitamin E) - Tibial Liner # 10 H. 16 mm Right
10manufacturers in China registered for this device type
120catalogue 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 |
| Record published | 2020-12-24 |
| Record revised | 2024-01-08 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6537.54.212 | # 2 H. 12 mm Left | In distribution |
| 6537.54.816 | # 8 H. 16 mm Left | In distribution |
| 6536.54.914 | # 9 H. 14 mm Right | In distribution |
| 6537.54.116 | # 1 H. 16 mm Left | In distribution |
| 6537.54.712 | # 7 H. 12 mm Left | In distribution |
| 6536.54.812 | # 8 H. 12 mm Right | In distribution |
| 6537.54.612 | # 6 H. 12 mm Left | In distribution |
| 6537.54.716 | # 7 H. 16 mm Left | In distribution |
| 6536.54.111 | # 1 H. 11 mm Right | In distribution |
| 6537.54.616 | # 6 H. 16 mm Left | In distribution |
| 6536.54.916 | # 9 H. 16 mm Right | In distribution |
| 6537.54.511 | # 5 H. 11 mm Left | In distribution |
| 6537.54.711 | # 7 H. 11 mm Left | In distribution |
| 6536.54.514 | # 5 H. 14 mm Right | In distribution |
| 6536.54.810 | # 8 H. 10 mm Right | In distribution |
| 6536.54.720 | # 7 H. 20 mm Right | In distribution |
| 6537.54.A20 | # 10 H. 20 mm Left | In distribution |
| 6536.54.610 | # 6 H. 10 mm Right | In distribution |
| 6536.54.A16 | # 10 H. 16 mm Right | In distribution |
| 6536.54.116 | # 1 H. 16 mm Right | In distribution |
| 6537.54.914 | # 9 H. 14 mm Left | In distribution |
| 6537.54.114 | # 1 H. 14 mm Left | In distribution |
| 6537.54.720 | # 7 H. 20 mm Left | In distribution |
| 6537.54.516 | # 5 H. 16 mm Left | In distribution |
| 6537.54.412 | # 4 H. 12 mm Left | In distribution |
| 6537.54.111 | # 1 H. 11 mm Left | In distribution |
| 6536.54.312 | # 3 H. 12 mm Right | In distribution |
| 6537.54.520 | # 5 H. 20 mm Left | In distribution |
| 6536.54.A14 | # 10 H. 14 mm Right | In distribution |
| 6536.54.216 | # 2 H. 16 mm Right | In distribution |
| 6537.54.110 | # 1 H. 10 mm Left | In distribution |
| 6537.54.814 | # 8 H. 14 mm Left | In distribution |
| 6536.54.411 | # 4 H. 11 mm Right | In distribution |
| 6536.54.120 | # 1 H. 20 mm Right | In distribution |
| 6536.54.A12 | # 10 H. 12 mm Right | In distribution |
| 6536.54.316 | # 3 H. 16 mm Right | In distribution |
| 6536.54.220 | # 2 H. 20 mm Right | In distribution |
| 6537.54.820 | # 8 H. 20 mm Left | In distribution |
| 6536.54.614 | # 6 H. 14 mm Right | In distribution |
| 6537.54.314 | # 3 H. 14 mm Left | In distribution |
| 6536.54.314 | # 3 H. 14 mm Right | In distribution |
| 6536.54.620 | # 6 H. 20 mm Right | In distribution |
| 6536.54.710 | # 7 H. 10 mm Right | In distribution |
| 6536.54.516 | # 5 H. 16 mm Right | In distribution |
| 6537.54.714 | # 7 H. 14 mm Left | In distribution |
| 6537.54.210 | # 2 H. 10 mm Left | In distribution |
| 6536.54.520 | # 5 H. 20 mm Right | In distribution |
| 6537.54.112 | # 1 H. 12 mm Left | In distribution |
| 6537.54.916 | # 9 H. 16 mm Left | In distribution |
| 6537.54.411 | # 4 H. 11 mm Left | In distribution |
| 6536.54.211 | # 2 H. 11 mm Right | In distribution |
| 6536.54.910 | # 9 H. 10 mm Right | In distribution |
| 6537.54.910 | # 9 H. 10 mm Left | In distribution |
| 6536.54.814 | # 8 H. 14 mm Right | In distribution |
| 6536.54.714 | # 7 H. 14 mm Right | In distribution |
| 6536.54.816 | # 8 H. 16 mm Right | In distribution |
| 6537.54.812 | # 8 H. 12 mm Left | In distribution |
| 6536.54.311 | # 3 H. 11 mm Right | In distribution |
| 6536.54.912 | # 9 H. 12 mm Right | In distribution |
| 6536.54.611 | # 6 H. 11 mm Right | In distribution |
| 6537.54.620 | # 6 H. 20 mm Left | In distribution |
| 6536.54.A10 | # 10 H. 10 mm Right | In distribution |
| 6536.54.510 | # 5 H. 10 mm Right | In distribution |
| 6536.54.420 | # 4 H. 20 mm Right | In distribution |
| 6537.54.414 | # 4 H. 14 mm Left | In distribution |
| 6536.54.820 | # 8 H. 20 mm Right | In distribution |
| 6536.54.414 | # 4 H. 14 mm Right | In distribution |
| 6536.54.412 | # 4 H. 12 mm Right | In distribution |
| 6537.54.A12 | # 10 H. 12 mm Left | In distribution |
| 6537.54.310 | # 3 H. 10 mm Left | In distribution |
| 6536.54.811 | # 8 H. 11 mm Right | In distribution |
| 6536.54.320 | # 3 H. 20 mm Right | In distribution |
| 6536.54.110 | # 1 H. 10 mm Right | In distribution |
| 6537.54.614 | # 6 H. 14 mm Left | In distribution |
| 6537.54.416 | # 4 H. 16 mm Left | In distribution |
| 6537.54.320 | # 3 H. 20 mm Left | In distribution |
| 6537.54.514 | # 5 H. 14 mm Left | In distribution |
| 6537.54.920 | # 9 H. 20 mm Left | In distribution |
| 6537.54.A14 | # 10 H. 14 mm Left | In distribution |
| 6537.54.611 | # 6 H. 11 mm Left | In distribution |
| 6537.54.510 | # 5 H. 10 mm Left | In distribution |
| 6536.54.712 | # 7 H. 12 mm Right | In distribution |
| 6536.54.716 | # 7 H. 16 mm Right | In distribution |
| 6536.54.920 | # 9 H. 20 mm Right | In distribution |
| 6537.54.512 | # 5 H. 12 mm Left | In distribution |
| 6537.54.A11 | # 10 H. 11 mm Left | In distribution |
| 6537.54.311 | # 3 H. 11 mm Left | In distribution |
| 6537.54.911 | # 9 H. 11 mm Left | In distribution |
| 6536.54.511 | # 5 H. 11 mm Right | In distribution |
| 6537.54.214 | # 2 H. 14 mm Left | In distribution |
| 6536.54.112 | # 1 H. 12 mm Right | In distribution |
| 6537.54.211 | # 2 H. 11 mm Left | In distribution |
| 6536.54.416 | # 4 H. 16 mm Right | In distribution |
| 6536.54.711 | # 7 H. 11 mm Right | In distribution |
| 6537.54.810 | # 8 H. 10 mm Left | In distribution |
| 6536.54.410 | # 4 H. 10 mm Right | In distribution |
| 6536.54.114 | # 1 H. 14 mm Right | In distribution |
| 6536.54.A11 | # 10 H. 11 mm Right | In distribution |
| 6536.54.512 | # 5 H. 12 mm Right | In distribution |
| 6537.54.316 | # 3 H. 16 mm Left | In distribution |
| 6536.54.616 | # 6 H. 16 mm Right | In distribution |
| 6536.54.310 | # 3 H. 10 mm Right | In distribution |
| 6536.54.911 | # 9 H. 11 mm Right | In distribution |
| 6536.54.212 | # 2 H. 12 mm Right | In distribution |
| 6537.54.610 | # 6 H. 10 mm Left | In distribution |
| 6536.54.A20 | # 10 H. 20 mm Right | In distribution |
| 6537.54.912 | # 9 H. 12 mm Left | In distribution |
| 6537.54.410 | # 4 H. 10 mm Left | In distribution |
| 6537.54.811 | # 8 H. 11 mm Left | In distribution |
| 6536.54.210 | # 2 H. 10 mm Right | In distribution |
| 6537.54.220 | # 2 H. 20 mm Left | In distribution |
| 6537.54.A10 | # 10 H. 10 mm Left | In distribution |
| 6537.54.120 | # 1 H. 20 mm Left | In distribution |
| 6537.54.312 | # 3 H. 12 mm Left | In distribution |
| 6537.54.A16 | # 10 H. 16 mm Left | In distribution |
| 6537.54.420 | # 4 H. 20 mm Left | In distribution |
| 6536.54.612 | # 6 H. 12 mm Right | In distribution |
| 6537.54.216 | # 2 H. 16 mm Left | In distribution |
| 6536.54.214 | # 2 H. 14 mm Right | In distribution |
| 6537.54.710 | # 7 H. 10 mm Left | 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 KR | Limacorporate | 128 |
| 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.