Physica Instrument Set
Tibial Positioner Inserter/Extractor
10manufacturers in China registered for this device type
100catalogue 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 | 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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| KR Trial Liner | #4 – H.12mm – R | In distribution |
| KR Trial Liner | #1 – H.10mm – R | In distribution |
| Trial Tibial Plate | # 8 | In distribution |
| KR Trial Liner | #3 – H.14mm – L | In distribution |
| KR Trial Liner | #8 – H.14mm – L | In distribution |
| KR Trial Liner | #1 – H.11mm – L | In distribution |
| KR Trial Liner | #7 – H.20mm – L | In distribution |
| KR Trial Liner | #7 – H.14mm – R | In distribution |
| Augments | H. 4mm | In distribution |
| KR Trial Liner | #8 – H.20mm – R | In distribution |
| Tibial Winged Broach | #6-#7-#8 | In distribution |
| Trial Tibial Plate | # 2 | In distribution |
| KR Trial Liner | #1 – H.16mm – R | In distribution |
| Femoral Sizer | In distribution | |
| KR Trial Liner | #8 – H.11mm – R | In distribution |
| Trial Tibial Plate | # 6 | In distribution |
| Tibial Depth Resection Gauge | 10/2mm | In distribution |
| IM Nail | Long | In distribution |
| Depth Stop Tibial Reamer | In distribution | |
| Tib. Positioner Inserter/Extractor | In distribution | |
| KR Trial Liner | #1 – H.20mm – L | In distribution |
| KR Trial Liner | #3 – H.16mm – R | In distribution |
| KR Trial Liner | #3 – H.11mm – L | In distribution |
| KR Trial Liner | #2 – H.20mm – L | In distribution |
| Trial Tibial Plate | In distribution | |
| Trial Tibial Plate | # 8 | In distribution |
| Tibial Guide | In distribution | |
| Tibial Cutting | L | In distribution |
| KR Trial Liner | #10 – H.20mm – R | In distribution |
| Tibial Winged Broach | #1-#2 | In distribution |
| Resection Jig | #9 | In distribution |
| KR Trial Liner | #5 – H.10mm – R | In distribution |
| KR Trial Liner | #9 – H.14mm – R | In distribution |
| KR Trial Liner | #5 – H.11mm – L | In distribution |
| KR Trial Liner | #9 – H.11mm – R | In distribution |
| KR Trial Liner | #2 – H.14mm – L | In distribution |
| KR Trial Liner | #4 – H.10mm – R | In distribution |
| KR Trial Liner | #7 – H.14mm – L | In distribution |
| Tibial Impactor | In distribution | |
| Tibial Cutting | In distribution | |
| KR Trial Liner | #3 – H.20mm – L | In distribution |
| KR Trial Liner | #10 – H.11mm – R | In distribution |
| KR Trial Liner | #10 – H.11mm – L | In distribution |
| Resection Jig | #7 | In distribution |
| KR Trial Liner | #6 – H.20mm – R | In distribution |
| KR Trial Liner | #7 – H.11mm – L | In distribution |
| Distal Hole Drill | In distribution | |
| KR Trial Liner | #5 – H.14mm – R | In distribution |
| KR Trial Liner | #6 – H.14mm – L | In distribution |
| Resection Jig | #1 | In distribution |
| KR Trial Liner | #3 – H.10mm – R | In distribution |
| KR Trial Liner | #4 – H.20mm – L | In distribution |
| KR Trial Liner | #9 – H.14mm – L | In distribution |
| Extension Spacer | H=11mm | In distribution |
| KR Trial Liner | #4 – H.14mm – L | In distribution |
| KR Trial Liner | #6 – H.20mm – L | In distribution |
| Trial Tibial Plate | # 4 | In distribution |
| Trial Tibial Plate | # 4 | In distribution |
| Augments | H. 2mm | In distribution |
| KR Trial Liner | #1 – H.12mm – R | In distribution |
| Liner Impactor | In distribution | |
| KR Trial Liner | #2 – H.11mm – L | In distribution |
| KR Trial Liner | #6 – H.11mm – L | In distribution |
| Valgus Tower | In distribution | |
| KR Trial Liner | #9 – H.20mm – L | In distribution |
| Resection Jig | #3 | In distribution |
| Tibial Cutting | R | In distribution |
| KR Trial Liner | #2 – H.12mm – R | In distribution |
| KR Trial Liner | #2 – H.16mm – R | In distribution |
| Guide Tibial Winged Broach | #6-#7-#8 | In distribution |
| KR Trial Liner | #4 – H.11mm – L | In distribution |
| Extension Spacer | H=14mm | In distribution |
| KR Trial Liner | #8 – H.11mm – L | In distribution |
| KR Trial Liner | #5 – H.14mm – L | In distribution |
| Trial Tibial Plate | # 10 | In distribution |
| Trial Tibial Plate | # 10 | In distribution |
| KR Trial Liner | #4 – H.16mm – R | In distribution |
| Trial Tibial Plate | # 6 | In distribution |
| KR Trial Liner | #8 – H.14mm – R | In distribution |
| KR Trial Liner | #10 – H.14mm – R | In distribution |
| KR Trial Liner | #3 – H.12mm – R | In distribution |
| Guide Tibial Winged Broach | #1-#2 | In distribution |
| KR Trial Liner | #5 – H.20mm – L | In distribution |
| KR Trial Liner | #7 – H.11mm – R | In distribution |
| Trial Tibial Plate | # 2 | In distribution |
| Resection Jig | #5 | In distribution |
| KR Trial Liner | #5 – H.20mm – R | In distribution |
| KR Trial Liner | #7 – H.20mm – R | In distribution |
| KR Trial Liner | #10 – H.14mm – L | In distribution |
| KR Trial Liner | #8 – H.20mm – L | In distribution |
| KR Trial Liner | #9 – H.20mm – R | In distribution |
| Sickle | In distribution | |
| KR Trial Liner | #9 – H.11mm – L | In distribution |
| KR Trial Liner | #2 – H.10mm – R | In distribution |
| Distal Femoral Jig | Small | In distribution |
| KR Trial Liner | #6 – H.14mm – R | In distribution |
| Sizer Augment | In distribution | |
| KR Trial Liner | #6 – H.11mm – R | In distribution |
| KR Trial Liner | #1 – H.14mm – L | In distribution |
| KR Trial Liner | #10 – H.20mm – L | 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 |
| Physica LMC | Limacorporate | 120 |
| Implant Partners | Microport Orthopedics Inc. | 119 |
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.