AMK
AMK TOTAL KNEE SYSTEM TIBIAL INSERT FIXED BEARING CONSTRAINED SIZE 4 18mm
10manufacturers in China registered for this device type
5catalogue numbers in this listing
5510(k) clearances naming this product code
11recalls on this code
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 | Depuy Orthopaedics, Inc., United States |
|---|---|
| FDA product code | HRY |
| Device type | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3530 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K864671 |
| Record published | 2015-09-24 |
| Record revised | 2018-07-06 (version 3) |
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 |
|---|---|---|
| 1688-64-025 | In distribution | |
| 1688-74-025 | In distribution | |
| 1688-54-025 | In distribution | |
| 1688-41-025 | In distribution | |
| 1688-52-025 | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K070267 | 2007-08-17 |
| K040268 | 2004-05-05 |
| K010810 | 2001-04-18 |
| K001451 | 2000-05-18 |
| K000172 | 2000-02-03 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2017-12-21 | Class II | Under Investigation by firm | The SIGMA HP PFJ Cemented Trochlear Implants, a standalone component of the partial knee system is being recalled based on elevated revision rates observed as part of the company s post market surveillance process. | 2110 | 2020-04-01 |
| 2006-11-15 | Not classified | Other | Chamfer Step Defect-The surgeon may have difficulty in assembling /seating the polyethylene insert into the tray due to a Chamfer step defect. | 558 for Recalls Z-0456-0465-2007 | 2008-04-30 |
| 2006-11-15 | Not classified | Other | Chamfer Step Defect-The surgeon may have difficulty in assembling /seating the polyethylene insert into the tray due to a Chamfer step defect. | 558 for Recalls Z-0456-0465-2007 | 2008-04-30 |
| 2006-11-15 | Not classified | Other | Chamfer Step Defect-The surgeon may have difficulty in assembling /seating the polyethylene insert into the tray due to a Chamfer step defect. | 558 for Recalls Z-0456-0465-2007 | 2008-04-30 |
| 2006-11-15 | Not classified | Other | Chamfer Step Defect-The surgeon may have difficulty in assembling /seating the polyethylene insert into the tray due to a Chamfer step defect. | 558 for Recalls Z-0456-0465-2007 | 2008-04-30 |
| 2006-11-15 | Not classified | Other | Chamfer Step Defect-The surgeon may have difficulty in assembling /seating the polyethylene insert into the tray due to a Chamfer step defect. | 558 for Recalls Z-0456-0465-2007 | 2008-04-30 |
| 2006-11-15 | Not classified | Other | Chamfer Step Defect-The surgeon may have difficulty in assembling /seating the polyethylene insert into the tray due to a Chamfer step defect. | 558 for Recalls Z-0456-0465-2007 | 2008-04-30 |
| 2006-11-15 | Not classified | Other | Chamfer Step Defect-The surgeon may have difficulty in assembling /seating the polyethylene insert into the tray due to a Chamfer step defect. | 558 for Recalls Z-0456-0465-2007 | 2008-04-30 |
| 2006-11-15 | Not classified | Other | Chamfer Step Defect-The surgeon may have difficulty in assembling /seating the polyethylene insert into the tray due to a Chamfer step defect. | 558 for Recalls Z-0456-0465-2007 | 2008-04-30 |
| 2006-11-15 | Not classified | Other | Chamfer Step Defect-The surgeon may have difficulty in assembling /seating the polyethylene insert into the tray due to a Chamfer step defect. | 558 for Recalls Z-0456-0465-2007 | 2008-04-30 |
| 2006-11-15 | Not classified | Other | Chamfer Step Defect-The surgeon may have difficulty in assembling /seating the polyethylene insert into the tray due to a Chamfer step defect. | 558 for Recalls Z-0456-0465-2007 | 2008-04-30 |
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.