Persona®
5 catalogue numbers from 20-8070-001-01, listed by Orthosoft, Inc., Canada, under Knee Arthroplasty Implantation System. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
5catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), Zhejiang (1). One is registered as a contract manufacturer, able to build to a 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 |
Record
| Listed by | Orthosoft, Inc., Canada |
|---|---|
| FDA product code | OOG |
| Device type | Knee Arthroplasty Implantation System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3560 |
| 510(k) | K131409 |
| Record published | 2017-09-28 |
| Record revised | 2023-01-26 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2020-09-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 20-8070-001-01 | Withdrawn | |
| 20-8070-011-01 | Withdrawn | |
| 20-8070-010-02 | Withdrawn | |
| 20-8070-010-01 | Withdrawn | |
| 20-8070-011-02 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Prophecy | Microport Orthopedics Inc. | 1,463 |
| PointCloud Knee Instruments | Unik Orthopedics, Inc | 202 |
| iTotal Identity CR | ConforMIS, Inc. | 138 |
| My Knee Femoral Cutting Blocks | Medacta International SA | 60 |
| iTotal® CR iPoly™ Insert Kit | ConforMIS, Inc. | 59 |
| My Knee Tibial Cutting Blocks | Medacta International SA | 48 |
| My Knee Femoral Cutting Blocks MIS | Medacta International SA | 42 |
| My Knee Tibial Cutting Blocks MIS | Medacta International SA | 36 |
| iTotal® Identity Cruciate Retaining Knee Replacement System | ConforMIS, Inc. | 27 |
| iTotal® CR iPoly® XE Insert Kit | ConforMIS, Inc. | 16 |
| Zimmer Patient Specific Instruments | Materialise NV | 12 |
| iTotal Identity CR Knee Replacement System | ConforMIS, Inc. | 12 |
Showing 12 of 95. All products under Knee Arthroplasty Implantation System
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Zimmer CAS | 510(k) number | 2014-11-03 | Class II | Software design | Internal discovery found that the MRI scans in some PSI knee guides involved an additional rotation adjustments that could potentially lead to misalignment due to a design flaw. | 15 | 2015-02-13 |
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.