Physica Instrument Set
Femoral Trial/PS Box Guide Inserter/Extractor
21manufacturers in China registered for this device type
243catalogue 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) | K151266 |
| Record published | 2016-06-07 |
| Record revised | 2024-09-11 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CR Trial Liner | #7 – H.10mm | In distribution |
| CR Trial Liner | #9 – H.16mm | In distribution |
| KR Trial Liner | #6 – H.12mm – R | In distribution |
| Tibial Plate Peg and Liner Extractor | In distribution | |
| KR Trial Liner | #5 – H.16mm – R | In distribution |
| Alignment Rod | Long | In distribution |
| CR Trial Liner | #2 – H.20mm | In distribution |
| CR Trial Liner | #3 – H.11mm | In distribution |
| CR Trial Liner | #8 – H.20mm | In distribution |
| KR Trial Liner | #10 – H.10mm – L | In distribution |
| CR Trial Liner | #3 – H.16mm | In distribution |
| KR Trial Liner | #4 – H.11mm – R | In distribution |
| Resection Jig | #8 | In distribution |
| CR Trial Liner | #10 – H.14mm | In distribution |
| Trial Patella | D.38mm h.10mm | In distribution |
| Guide Tibial Winged Broach | #9-#10 | In distribution |
| PS Trial Liner | #4 – H.12mm | In distribution |
| CR Trial Liner | #5 – H.16mm | In distribution |
| PS Trial Liner | #10 – H.14mm | In distribution |
| CR Trial Liner | #6 – H.11mm | In distribution |
| KR Trial Liner | #2 – H.12mm – L | In distribution |
| PS Trial Liner | #1 – H.20mm | In distribution |
| PS Box Cutting Guide | # 1 | In distribution |
| PS Trial Liner | #2 – H.16mm | In distribution |
| CR Trial Liner | #4 – H.20mm | In distribution |
| Trial Tibial Plate | # 7 | In distribution |
| PS Trial Liner | #8 – H.11mm | In distribution |
| KR Trial Liner | #7 – H.16mm – R | In distribution |
| PS Trial Liner | #6 – H.11mm | In distribution |
| PS Trial Liner | #10 – H.11mm | In distribution |
| Trial Tibial Plate | # 1 | In distribution |
| CR Trial Liner | #10 – H.11mm | In distribution |
| CR Trial Liner | #5 – H.20mm | In distribution |
| CR Trial Liner | #7 – H.14mm | In distribution |
| PS Trial Liner | #10 – H.10mm | In distribution |
| KR Trial Liner | #3 – H.10mm – L | In distribution |
| KR Trial Liner | #1 – H.20mm – R | In distribution |
| Trial Tibial Plate | # 5 | In distribution |
| KR Trial Liner | #3 – H.12mm – L | In distribution |
| KR Trial Liner | #7 – H.16mm – L | In distribution |
| CR Trial Liner | #5 – H.10mm | In distribution |
| Trial Patella | D.41mm h.10mm | In distribution |
| Trial Tibial Plate | # 1 | In distribution |
| KR Trial Liner | #10 – H.12mm – L | In distribution |
| PS Trial Liner | #3 – H.10mm | In distribution |
| KR Trial Liner | #7 – H.12mm – R | In distribution |
| PS Trial Liner | #1 – H.12mm | In distribution |
| CR Trial Liner | #6 – H.12mm | In distribution |
| CR Trial Liner | #4 – H.11mm | In distribution |
| CR Trial Liner | #6 – H.10mm | In distribution |
| PS Trial Liner | #1 – H.16mm | In distribution |
| PS Trial Liner | #2 – H.12mm | In distribution |
| Resection Jig | #6 | In distribution |
| CR Trial Liner | #2 – H.16mm | In distribution |
| PS Trial Liner | #7 – H.12mm | In distribution |
| PS Box Cutting Guide | # 6 | In distribution |
| CR Trial Liner | #7 – H.20mm | In distribution |
| Extension Spacer | H=12mm | In distribution |
| PS Trial Liner | #8 – H.16mm | In distribution |
| PS Trial Liner | #6 – H.10mm | In distribution |
| KR Trial Liner | #5 – H.10mm – L | In distribution |
| Augments | H. 3mm | In distribution |
| PS Trial Liner | #2 – H.11mm | In distribution |
| PS Trial Liner | #10 – H.20mm | In distribution |
| CR Trial Liner | #2 – H.11mm | In distribution |
| CR Trial Liner | #7 – H.11mm | In distribution |
| CR Trial Liner | #3 – H.20mm | In distribution |
| PS Box Cutting Guide | # 3 | In distribution |
| CR Trial Liner | #5 – H.14mm | In distribution |
| CR Trial Liner | #5 – H.12mm | In distribution |
| Tibial Guide with Clamp | In distribution | |
| Trial Patella | D.32mm h.8.5mm | In distribution |
| Trial Patella | D.35mm h.8.5mm | In distribution |
| PS Trial Liner | #3 – H.14mm | In distribution |
| CR Trial Liner | #4 – H.10mm | In distribution |
| CR Trial Liner | #9 – H.20mm | In distribution |
| PS Box Cutting Guide | # 9 | In distribution |
| Patellar Pegs Drill | In distribution | |
| Stylus | In distribution | |
| CR Trial Liner | #1 – H.12mm | In distribution |
| PS Trial Liner | #4 – H.16mm | In distribution |
| Femoral Sizer for Balancer | In distribution | |
| Tibial Cutting | L Slope 3° | In distribution |
| PS Trial Liner | #1 – H.11mm | In distribution |
| KR Trial Liner | #6 – H.10mm – L | In distribution |
| PS Trial Liner | #6 – H.12mm | In distribution |
| Femoral Peg Inserter | In distribution | |
| KR Trial Liner | #9 – H.16mm – L | In distribution |
| Trial Tibial Plate | # 9 | In distribution |
| KR Trial Liner | #9 – H.12mm – L | In distribution |
| PS Trial Liner | #5 – H.20mm | In distribution |
| KR Trial Liner | #3 – H.11mm – R | In distribution |
| PS Trial Liner | #2 – H.14mm | In distribution |
| Resection Jig | #4 | In distribution |
| CR Trial Liner | #10 – H.12mm | In distribution |
| KR Trial Liner | #5 – H.12mm – L | In distribution |
| CR Trial Liner | #3 – H.14mm | In distribution |
| CR Trial Liner | #10 – H.16mm | In distribution |
| CR Trial Liner | #6 – H.14mm | In distribution |
| CR Trial Liner | #2 – H.10mm | In distribution |
| CR Trial Liner | #2 – H.12mm | In distribution |
| KR Trial Liner | #8 – H.10mm – R | In distribution |
| IM Nail | Short | In distribution |
| CR Trial Liner | #6 – H.16mm | In distribution |
| PS Trial Liner | #3 – H.12mm | In distribution |
| CR Trial Liner | #2 – H.14mm | In distribution |
| KR Trial Liner | #9 – H.10mm – R | In distribution |
| Distal Femoral Jig | Large | In distribution |
| CR Trial Liner | #4 – H.16mm | In distribution |
| KR Trial Liner | #8 – H.16mm – L | In distribution |
| PS Trial Liner | #3 – H.20mm | In distribution |
| CR Trial Liner | #3 – H.10mm | In distribution |
| CR Trial Liner | #1 – H.14mm | In distribution |
| Fem. Positioner Inserter/Extractor | In distribution | |
| PS Trial Liner | #5 – H.14mm | In distribution |
| PS Box Cutting Guide | # 5 | In distribution |
| KR Trial Liner | #1 – H.11mm – R | In distribution |
| KR Trial Liner | #7 – H.10mm – L | In distribution |
| KR Trial Liner | #4 – H.10mm – L | In distribution |
| KR Trial Liner | #4 – H.14mm – R | In distribution |
| KR Trial Liner | #6 – H.16mm – L | In distribution |
| CR Trial Liner | #8 – H.11mm | In distribution |
| PS Trial Liner | #9 – H.11mm | In distribution |
| CR Trial Liner | #7 – H.16mm | In distribution |
| Tibial Cutting | R Slope 3° | In distribution |
| PS Trial Liner | #9 – H.20mm | In distribution |
| PS Box Cutting Guide | # 8 | In distribution |
| CR Trial Liner | #8 – H.14mm | In distribution |
| PS Trial Liner | #9 – H.12mm | In distribution |
| KR Trial Liner | #8 – H.16mm – R | In distribution |
| PS Trial Liner | #5 – H.12mm | In distribution |
| CR Trial Liner | #9 – H.14mm | In distribution |
| PS Trial Liner | #8 – H.20mm | In distribution |
| PS Trial Liner | #1 – H.10mm | In distribution |
| PS Trial Liner | #5 – H.16mm | In distribution |
| KR Trial Liner | #2 – H.20mm – R | In distribution |
| Fem. Trial/PS Box Guide Ins./Extr. | In distribution | |
| Guide Tibial Winged Broach | #3-#4-#5 | In distribution |
| Patellar Sizing Template | In distribution | |
| PS Trial Liner | #9 – H.10mm | In distribution |
| CR Trial Liner | #10 – H.10mm | In distribution |
| PS Trial Liner | #4 – H.20mm | In distribution |
| KR Trial Liner | #4 – H.20mm – R | In distribution |
| KR Trial Liner | #10 – H.10mm – R | In distribution |
| KR Trial Liner | #1 – H.12mm – L | In distribution |
| PS Trial Liner | #7 – H.14mm | In distribution |
| KR Trial Liner | #7 – H.12mm – L | In distribution |
| PS Trial Liner | #7 – H.11mm | In distribution |
| Femoral Shift Block | In distribution | |
| Augments | H. 1mm | In distribution |
| CR Trial Liner | #8 – H.12mm | In distribution |
| Extension Spacer | H 10mm | In distribution |
| PS Trial Liner | #3 – H.11mm | In distribution |
| KR Trial Liner | #4 – H.16mm – L | In distribution |
| KR Trial Liner | #3 – H.14mm – R | In distribution |
| KR Trial Liner | #8 – H.12mm – R | In distribution |
| KR Trial Liner | #6 – H.10mm – R | In distribution |
| KR Trial Liner | #9 – H.10mm – L | In distribution |
| KR Trial Liner | #1 – H.16mm – L | In distribution |
| Tibial Cutting | Slope 3° | In distribution |
| CR Trial Liner | #1 – H.20mm | In distribution |
| Trial Tibial Plate | # 3 | In distribution |
| Trial Tibial Plate | # 5 | In distribution |
| PS Trial Liner | #8 – H.10mm | In distribution |
| PS Trial Liner | #8 – H.14mm | In distribution |
| Trial Patella | D.29mm h.7mm | In distribution |
| PS Trial Liner | #10 – H.16mm | In distribution |
| KR Trial Liner | #2 – H.14mm – R | In distribution |
| PS Trial Liner | #2 – H.20mm | In distribution |
| KR Trial Liner | #7 – H.10mm – R | In distribution |
| KR Trial Liner | #9 – H.12mm – R | In distribution |
| Femoral Alignment Guide | In distribution | |
| PS Trial Liner | #10 – H.12mm | In distribution |
| Resection Jig | #2 | In distribution |
| PS Box Cutting Guide | # 10 | In distribution |
| KR Trial Liner | #8 – H.10mm – L | In distribution |
| Tibial Reamer | In distribution | |
| PS Trial Liner | #5 – H.10mm | In distribution |
| KR Trial Liner | #9 – H.16mm – R | In distribution |
| Trial Tibial Plate | # 7 | In distribution |
| KR Trial Liner | #5 – H.11mm – R | In distribution |
| PS Trial Liner | #7 – H.16mm | In distribution |
| PS Trial Liner | #7 – H.10mm | In distribution |
| Alignment Rod | In distribution | |
| KR Trial Liner | #4 – H.12mm – L | In distribution |
| KR Trial Liner | #2 – H.11mm – R | In distribution |
| PS Box Cutting Guide | # 7 | In distribution |
| CR Trial Liner | #9 – H.11mm | In distribution |
| PS Trial Liner | #6 – H.14mm | In distribution |
| Trial Tibial Plate | In distribution | |
| Trial Tibial Plate | # 9 | In distribution |
| KR Trial Liner | #6 – H.16mm – R | In distribution |
| Trial Patella | D.26mm h.7mm | In distribution |
| KR Trial Liner | #2 – H.10mm – L | In distribution |
| Tibial Winged Broach | #9-#10 | In distribution |
| KR Trial Liner | #2 – H.16mm – L | In distribution |
| PS Trial Liner | #4 – H.10mm | In distribution |
| PS Box Cutting Guide | # 2 | In distribution |
| CR Trial Liner | #7 – H.12mm | In distribution |
| PS Trial Liner | #4 – H.14mm | In distribution |
| Extension Spacer | H=16mm | In distribution |
| CR Trial Liner | #9 – H.10mm | In distribution |
| KR Trial Liner | #10 – H.12mm – R | In distribution |
| Resection Jig | #10 | In distribution |
| PS Trial Liner | #6 – H.16mm | In distribution |
| Tibial Winged Broach | #3-#4-#5 | In distribution |
| CR Trial Liner | #5 – H.11mm | In distribution |
| PS Box Cutting Guide | # 4 | In distribution |
| PS Trial Liner | #4 – H.11mm | In distribution |
| CR Trial Liner | #3 – H.12mm | In distribution |
| KR Trial Liner | #10 – H.16mm – L | In distribution |
| KR Trial Liner | #6 – H.12mm – L | In distribution |
| KR Trial Liner | #1 – H.14mm – R | In distribution |
| CR Trial Liner | #4 – H.12mm | In distribution |
| KR Trial Liner | #8 – H.12mm – L | In distribution |
| PS Trial Liner | #3 – H.16mm | In distribution |
| CR Trial Liner | #10 – H.20mm | In distribution |
| PS Trial Liner | #2 – H.10mm | In distribution |
| KR Trial Liner | #5 – H.12mm – R | In distribution |
| Femoral Impactor | In distribution | |
| Trial Tibial Plate | # 3 | In distribution |
| KR Trial Liner | #5 – H.16mm – L | In distribution |
| PS Trial Liner | #1 – H.14mm | In distribution |
| KR Trial Liner | #10 – H.16mm – R | In distribution |
| Femoral Pegs Drill | In distribution | |
| Extension Spacer | H=10mm | In distribution |
| CR Trial Liner | #8 – H.10mm | In distribution |
| PS Trial Liner | #6 – H.20mm | In distribution |
| KR Trial Liner | #1 – H.10mm – L | In distribution |
| KR Trial Liner | #3 – H.16mm – L | In distribution |
| PS Trial Liner | #5 – H.11mm | In distribution |
| CR Trial Liner | #1 – H.11mm | In distribution |
| PS Trial Liner | #8 – H.12mm | In distribution |
| PS Trial Liner | #9 – H.16mm | In distribution |
| CR Trial Liner | #1 – H.16mm | In distribution |
| CR Trial Liner | #8 – H.16mm | In distribution |
| CR Trial Liner | #9 – H.12mm | In distribution |
| PS Trial Liner | #7 – H.20mm | In distribution |
| CR Trial Liner | #6 – H.20mm | In distribution |
| PS Trial Liner | #9 – H.14mm | In distribution |
| KR Trial Liner | #3 – H.20mm – R | In distribution |
| CR Trial Liner | #4 – H.14mm | In distribution |
| CR Trial Liner | #1 – H.10mm | 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.