Persona®
117 catalogue numbers from 42-5381-005-01, listed by Zimmer, Inc., United States, under Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer. 6 manufacturers in China are registered for this product code.
6manufacturers in China registered for this device type
117catalogue numbers in this listing
9510(k) clearances naming this product code
5recalls on this code
Who Else Makes It
Concentrated in Zhejiang (2), Jiangsu (2), Shanghai (1). 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 |
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | 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 |
Record
| Listed by | Zimmer, Inc., United States |
|---|---|
| FDA product code | HSX |
| Device type | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3520 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K161592 |
| Record published | 2016-11-29 |
| Record revised | 2022-03-22 (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 |
|---|---|---|
| 42-5381-005-01 | Size E | In distribution |
| 42-5181-005-14 | 14 mm Thickness, Size E | In distribution |
| 42-5781-004-02 | Size 4 | In distribution |
| 42-5399-053-95 | 5 Degrees, 2mm Depth | In distribution |
| 42-5781-003-02 | Size 3 | In distribution |
| 42-5181-003-10 | 10 mm Thickness, Size C | In distribution |
| 42-5781-008-01 | Size 8 | In distribution |
| 42-5181-008-09 | 9 mm Thickness, Size H | In distribution |
| 42-5181-006-12 | Size F, 12 mm Thickness | In distribution |
| 42-5781-005-02 | Size 5 | In distribution |
| 42-5181-003-14 | 14 mm Thickness, Size C | In distribution |
| 42-5581-002-02 | Size 2 | In distribution |
| 42-5181-004-08 | 8 mm Thickness, Size D | In distribution |
| 42-5181-008-12 | 12 mm Thickness, Size H | In distribution |
| 42-5181-006-08 | Size F, 8 mm Thickness | In distribution |
| 42-5399-052-95 | 5 Degrees | In distribution |
| 42-5581-003-02 | Size 3 | In distribution |
| 42-5781-005-01 | Size 5 | In distribution |
| 42-5781-008-02 | Size 8 | In distribution |
| 42-5399-053-85 | 2 mm Depth | In distribution |
| 42-5581-007-02 | Size 7 | In distribution |
| 42-5580-008-02 | Size 8 | In distribution |
| 42-5399-054-95 | 5 Degrees, 2mm Depth | In distribution |
| 42-5581-006-01 | Size 6 | In distribution |
| 42-5381-005-01 | Size E | In distribution |
| 42-5381-008-02 | Size H | In distribution |
| 42-5781-007-02 | Size 7 | In distribution |
| 42-5381-003-02 | Size C | In distribution |
| 42-5381-009-02 | Size J | In distribution |
| 42-5181-003-08 | 8 mm Thickness, Size C | In distribution |
| 42-5181-009-11 | 11 mm Thickness, Size J | In distribution |
| 42-5181-009-14 | 14 mm Thickness, Size J | In distribution |
| 42-5181-004-11 | 11 mm Thickness, Size D | In distribution |
| 42-5581-008-02 | Size 8 | In distribution |
| 42-5181-005-08 | 8 mm Thickness, Size E | In distribution |
| 42-5381-008-01 | Size H | In distribution |
| 42-5581-003-01 | Size 3 | In distribution |
| 42-5181-005-11 | 11 mm Thickness, Size E | In distribution |
| 42-5181-009-08 | 8 mm Thickness, Size J | In distribution |
| 42-5381-004-01 | Size D | In distribution |
| 42-5581-006-02 | Size 6 | In distribution |
| 42-5181-004-14 | 14 mm Thickness, Size D | In distribution |
| 42-5381-005-02 | Size E | In distribution |
| 42-5181-006-09 | 9 mm Thickness, Size F | In distribution |
| 42-5181-003-12 | 12 mm Thickness, Size C | In distribution |
| 42-5399-051-85 | 5° Captured | In distribution |
| 42-5181-003-11 | 11 mm Thickness, Size C | In distribution |
| 42-5181-007-09 | 9 mm Thickness, Size G | In distribution |
| 42-5781-001-02 | Size 1 | In distribution |
| 42-5181-007-08 | 8 mm Thickness, Size G | In distribution |
| 42-5399-080-78 | Size F/G | In distribution |
| 42-5181-008-14 | 14 mm Thickness, Size H | In distribution |
| 42-5381-004-01 | Size D | In distribution |
| 42-5781-002-02 | Size 2 | In distribution |
| 42-5399-049-00 | In distribution | |
| 42-5399-080-90 | Size H/J | In distribution |
| 42-5181-005-12 | 12 mm Thickness, Size E | In distribution |
| 42-5381-004-02 | Size D | In distribution |
| 42-5581-001-02 | Size 1 | In distribution |
| 42-5581-007-01 | Size 7 | In distribution |
| 42-5181-004-09 | 9 mm Thickness, Size D | In distribution |
| 42-5181-007-10 | 10 mm Thickness, Size G | In distribution |
| 42-5181-006-10 | 10 mm Thickness, Size F | In distribution |
| 42-5399-059-85 | 2 mm Depth | In distribution |
| 42-5399-080-56 | Size D/E | In distribution |
| 42-5181-005-10 | 10 mm Thickness, Size E | In distribution |
| 42-5781-003-01 | Size 3 | In distribution |
| 42-5181-006-14 | 14 mm Thickness, Size F | In distribution |
| 42-5381-003-01 | Size C | In distribution |
| 42-5381-003-02 | Size C | In distribution |
| 42-5181-009-12 | 12 mm Thickness, Size J | In distribution |
| 42-5181-008-10 | 10 mm Thickness, Size H | In distribution |
| 42-5381-009-01 | Size J | In distribution |
| 42-5781-001-01 | Size 1 | In distribution |
| 42-5181-008-08 | 8 mm Thickness, Size H | In distribution |
| 42-5381-008-02 | Size H | In distribution |
| 42-5581-005-02 | Size 5 | In distribution |
| 42-5181-005-09 | 9 mm Thickness, Size E | In distribution |
| 42-5399-080-34 | Size B/C | In distribution |
| 42-5381-007-01 | Size G | In distribution |
| 42-5580-008-01 | Size 8 | In distribution |
| 42-5381-007-02 | Size G | In distribution |
| 42-5399-051-95 | 5 Degrees | In distribution |
| 42-5381-006-01 | Size F | In distribution |
| 42-5181-004-12 | 12 mm Thickness, Size D | In distribution |
| 42-5181-009-09 | 9 mm Thickness, Size J | In distribution |
| 42-5181-009-10 | 10 mm Thickness, Size J | In distribution |
| 42-5381-007-02 | Size G | In distribution |
| 42-5581-005-01 | Size 5 | In distribution |
| 42-5181-004-10 | 10 mm Thickness, Size D | In distribution |
| 42-5381-006-02 | Size F | In distribution |
| 42-5181-007-12 | 12 mm Thickness, Size G | In distribution |
| 42-5781-004-01 | Size 4 | In distribution |
| 42-5581-008-01 | Size 8 | In distribution |
| 42-5181-003-09 | 9 mm Thickness, Size C | In distribution |
| 42-5581-004-02 | Size 4 | In distribution |
| 42-5181-007-11 | 11 mm Thickness, Size G | In distribution |
| 42-5181-007-14 | 14 mm Thickness, Size G | In distribution |
| 42-5181-008-11 | 11 mm Thickness, Size H | In distribution |
| 42-5381-009-02 | Size J | In distribution |
| 42-5381-005-02 | Size E | In distribution |
| 42-5781-006-02 | Size 6 | In distribution |
| 42-5781-006-01 | Size 6 | In distribution |
| 42-5581-002-01 | Size 2 | In distribution |
| 42-5781-007-01 | Size 7 | In distribution |
| 42-5399-052-85 | 5° Captured | In distribution |
| 42-5381-006-02 | Size F | In distribution |
| 42-5381-003-01 | Size C | In distribution |
| 42-5581-004-01 | Size 4 | In distribution |
| 42-5181-006-11 | 11 mm Thickness, Size F | In distribution |
| 42-5381-007-01 | Size G | In distribution |
| 42-5381-008-01 | Size H | In distribution |
| 42-5381-004-02 | Size D | In distribution |
| 42-5381-006-01 | Size F | In distribution |
| 42-5781-002-01 | Size 2 | In distribution |
| 42-5381-009-01 | Size J | In distribution |
| 42-5581-001-01 | Size 1 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Journey | Smith & Nephew, Inc. | 517 |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | Ortho Development Corp. | 303 |
| BKS® Uni | Ortho Development Corp. | 240 |
| LinkSymphoKnee | Waldemar Link GmbH & Co. KG | 210 |
| Moto Partial Knee System | Medacta International SA | 205 |
| Arthrex® | Arthrex, Inc. | 199 |
| Stride | Smith & Nephew, Inc. | 190 |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | Zimmer, Inc. | 175 |
| ZUK | Smith & Nephew, Inc. | 161 |
| Tahoe Uni Knee System | Shalby Advanced Technologies, Inc. | 134 |
| Moto Partial Knee System – Medial | Medacta International SA | 132 |
| Journey II | Smith & Nephew, Inc. | 119 |
Showing 12 of 171. All products under Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K200151 | 2020-03-17 |
| K122529 | 2012-11-16 |
| K033363 | 2004-01-16 |
| K010685 | 2001-04-02 |
| K952068 | 1995-09-19 |
| K942263 | 1995-07-11 |
| K880155 | 1988-08-03 |
| K862632 | 1987-03-25 |
| K803235 | 1981-02-04 |
Recalls Naming This Product
2 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 |
|---|---|---|---|---|---|---|---|
| Biomet, Inc. | 510(k) number | 2017-11-29 | Class II | Nonconforming Material/Component | Certain partial knee implant spacer blocks do not fit in the alignment tower instrument or handle. | 1023 | 2019-04-05 |
| Biomet, Inc. | 510(k) number | 2017-07-05 | Class II | Device Design | Finishing guide does not adequately account for shape differences present in Size 8 of Persona Partial Knee System, potentially resulting in additional surgery time or sensation of tightness during knee flexion. | 158 devices | 2019-04-02 |
Recalls
4 of these are 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 |
|---|---|---|---|---|---|
| 2017-11-29 | Class II | Packaging | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag. | 13,227 in total | 2020-04-02 |
| 2017-11-29 | Class II | Packaging | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag. | 13,227 in total | 2020-04-02 |
| 2016-01-11 | Class II | Process control | LDPE bag containing the implant adheres to the highly polished implant surface. | 32537 | 2017-05-23 |
| 2013-08-30 | Class II | Package design/selection | The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices. | 32537 | 2014-09-25 |
| 2009-02-26 | Not classified | Process control | Smaller diameter screws than required were included in the package. | 13 | 2011-02-28 |
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.