Persona® the Personalized Knee®
41 catalogue numbers from 42-5399-001-20, 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
41catalogue 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) | K221479 |
| Record published | 2022-11-23 |
| Record revised | 2023-03-17 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 42-5399-001-20 | In distribution | |
| 42-5903-075-32 | 32mm | In distribution |
| 42-5276-008-10 | Size 10-11 EF | In distribution |
| 42-5276-007-07 | +0 Thickness, Size GH | In distribution |
| 42-5176-005-05 | +0 Thickness, Size EF | In distribution |
| 42-5276-005-10 | Size 6-9 CD | In distribution |
| 42-5903-075-38 | 38mm | In distribution |
| 110047397 | Size 35-41mm | In distribution |
| 42-5399-075-21 | 0° Keel, Size F | In distribution |
| 42-5276-003-03 | +0 Thickness, Size CD | In distribution |
| 42-5870-007-21 | In distribution | |
| 42-5176-005-15 | +6 Thickness, Size EF | In distribution |
| 42-5399-064-22 | 0° Keel, Size C | In distribution |
| 42-5176-004-10 | Size 3-5 CD | In distribution |
| 42-5399-088-21 | 0° Keel, Size J | In distribution |
| 42-5176-007-10 | Size 6-9 EF | In distribution |
| 42-5176-008-10 | Size 10-11 EF | In distribution |
| 42-5399-058-21 | 0° Keel, Size A | In distribution |
| 42-5399-083-21 | 0° Keel, Size H | In distribution |
| 42-5399-071-21 | 0° Keel, Size E | In distribution |
| 42-5399-020-20 | 0° Keel | In distribution |
| 42-5176-007-17 | +6 Thickness, Size GH | In distribution |
| 42-5360-075-01 | Size F, 0°, Keel | In distribution |
| 42-5360-088-01 | Size J, 0°, Keel | In distribution |
| 110047396 | Size 26-32mm | In distribution |
| 42-5360-067-02 | Size D, 0°, Keel | In distribution |
| 42-5360-058-01 | Size A, 0°, Keel | In distribution |
| 42-5399-083-22 | 0° Keel, Size H | In distribution |
| 42-5276-005-05 | +0 Thickness, Size EF | In distribution |
| 42-5399-058-22 | 0° Keel, Size A | In distribution |
| 42-5903-090-38 | 38mm | In distribution |
| 42-5360-071-02 | Size E, 0°, Keel | In distribution |
| 42-5903-075-35 | 35mm | In distribution |
| 42-5399-051-22 | 2° | In distribution |
| 42-5360-061-02 | Size B, 0°, Keel | In distribution |
| 42-5360-067-01 | Size D, 0°, Keel | In distribution |
| 42-5399-022-25 | 0° Keel, Size E-F | In distribution |
| 42-5399-051-25 | 5° | In distribution |
| 42-5176-009-10 | Size 6-9 GH | In distribution |
| 42-5399-018-31 | 0° Keel | In distribution |
| 42-5399-051-05 | 5° | In distribution |
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 Naming This Product
10 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Zimmer, Inc. | 510(k) number | 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 |
| Zimmer, Inc. | 510(k) number | 2014-08-07 | Class II | Device Design | Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona primary knee surgical technique has been updated. This field action correction is to ensure that all distributors and users of this instrument | 77,737 units total | 2015-01-27 |
| Zimmer, Inc. | 510(k) number | 2014-08-07 | Class II | Device Design | Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona primary knee surgical technique has been updated. This field action correction is to ensure that all distributors and users of this instrument | 77,737 units total | 2015-01-27 |
| Zimmer, Inc. | 510(k) number | 2014-08-07 | Class II | Device Design | Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona primary knee surgical technique has been updated. This field action correction is to ensure that all distributors and users of this instrument | 77,737 total units | 2015-01-27 |
| Zimmer, Inc. | 510(k) number | 2014-08-07 | Class II | Device Design | Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona primary knee surgical technique has been updated. This field action correction is to ensure that all distributors and users of this instrument | 77,737 total units | 2015-01-27 |
| Zimmer, Inc. | 510(k) number | 2014-08-07 | Class II | Device Design | Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona primary knee surgical technique has been updated. This field action correction is to ensure that all distributors and users of this instrument | 77,737 total units | 2015-01-27 |
| Zimmer, Inc. | 510(k) number | 2014-08-07 | Class II | Device Design | Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona primary knee surgical technique has been updated. This field action correction is to ensure that all distributors and users of this instrument | 77,737 total units | 2015-01-27 |
| Zimmer, Inc. | 510(k) number | 2013-06-10 | Class II | Device Design | Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). This is a retrospective recall which covers Zimmer’s corrective actions taken earlier this year concerning the TASPs. | 70,986 distribution events | 2014-09-11 |
| Zimmer, Inc. | 510(k) number | 2013-06-10 | Class II | Device Design | Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). This is a retrospective recall which covers Zimmer’s corrective actions taken earlier this year concerning the TASPs. | 70,986 distribution events | 2014-09-11 |
| Zimmer, Inc. | 510(k) number | 2013-06-10 | Class II | Device Design | Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). This is a retrospective recall which covers Zimmer’s corrective actions taken earlier this year concerning the TASPs. | 70,986 distribution events | 2014-09-11 |
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.