Persona® Persona SoluTion™
32 catalogue numbers from 42-5070-050-01, listed by Zimmer, Inc., United States, under Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive. 8 manufacturers in China are registered for this product code.
8manufacturers in China registered for this device type
32catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Jiangsu (4), Shanghai (2), Zhejiang (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| b-ONE Medical (Beijing) Co., Ltd. | Beijing | Beijing | Contract manufacturer | 7 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Zimmer, Inc., United States |
|---|---|
| FDA product code | OIY |
| Device type | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3560 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K142787 |
| Record published | 2015-09-24 |
| Record revised | 2020-10-20 (version 5) |
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 |
| Distribution end date | 2016-11-07 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 42-5070-050-01 | Narrow, Size 1 | Withdrawn |
| 42-5050-064-02 | Narrow, Size, 8 | Withdrawn |
| 42-5056-066-02 | Standard, Size, 9 | Withdrawn |
| 42-5076-074-01 | Standard, Size 12 | Withdrawn |
| 42-5056-058-02 | Standard, Size, 5 | Withdrawn |
| 42-5050-070-01 | Narrow, Size, 11 | Withdrawn |
| 42-5076-064-02 | Standard, Size 8 | Withdrawn |
| 42-5070-068-01 | Narrow, Size 10 | Withdrawn |
| 42-5056-054-02 | Standard, Size, 3 | Withdrawn |
| 42-5050-062-02 | Narrow, Size, 7 | Withdrawn |
| 42-5056-054-01 | Standard, Size, 3 | Withdrawn |
| 42-5076-068-01 | Standard, Size 10 | Withdrawn |
| 42-5070-068-02 | Narrow, Size 10 | Withdrawn |
| 42-5076-058-01 | Standard, Size 5 | Withdrawn |
| 42-5076-066-02 | Standard, Size 9 | Withdrawn |
| 42-5056-064-02 | Standard, Size, 8 | Withdrawn |
| 42-5050-050-02 | Narrow, Size, 1 | Withdrawn |
| 42-5076-060-01 | Standard, Size 6 | Withdrawn |
| 42-5076-074-02 | Standard, Size 12 | Withdrawn |
| 42-5050-066-01 | Narrow, Size, 9 | Withdrawn |
| 42-5076-064-01 | Standard, Size 8 | Withdrawn |
| 42-5056-066-01 | Standard, Size, 9 | Withdrawn |
| 42-5050-052-01 | Narrow, Size, 2 | Withdrawn |
| 42-5050-054-01 | Narrow, Size, 3 | Withdrawn |
| 42-5050-064-01 | Narrow, Size, 8 | Withdrawn |
| 42-5070-054-02 | Narrow, Size 3 | Withdrawn |
| 42-5070-052-02 | Narrow, Size 2 | Withdrawn |
| 42-5050-056-01 | Narrow, Size, 4 | Withdrawn |
| 42-5056-068-01 | Standard, Size, 10 | Withdrawn |
| 42-5070-056-02 | Narrow, Size 4 | Withdrawn |
| 42-5070-054-01 | Narrow, Size 3 | Withdrawn |
| 42-5070-062-02 | Narrow, Size 7 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Persona® | Zimmer, Inc. | 552 |
| DJO Surgical | Encore Medical, L.P. | 415 |
| Genflex2 Total Knee System | Globus Medical, Inc. | 389 |
| Persona® Vivacit-E® | Zimmer, Inc. | 332 |
| Truliant, Activit-E | Exactech, Inc. | 272 |
| TriVerse Meniscal Insert PS | Signature Orthopaedics PTY Limited | 220 |
| U2™ Knee | United Orthopedic Corp. | 195 |
| BKS E-Vitalize | Ortho Development Corp. | 193 |
| Vanguard XP Instrumentation | Biomet Orthopedics | 169 |
| Attune | Depuy (Ireland) | 161 |
| Vanguard Complete Knee System | Biomet Orthopedics | 153 |
| EXp Tibial Inserts and Patellar Components | Globus Medical, Inc. | 144 |
Showing 12 of 102. All products under Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
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 |
|---|---|---|---|---|---|
| 2014-12-11 | Class II | Device Design | Potential for delay in surgery and/or ball bearings to be left in the wound. Repeated cycles of sonic cleaning can break down the ball bearing retention feature (swage) on the shim. To prevent this, TASP shims must be manually cleaned and i | 67963 | 2015-10-23 |
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.