Genesis II
Genesis II 7 Degree Full TIB Wedge Cutting Block
6manufacturers in China registered for this device type
16catalogue numbers in this listing
13510(k) clearances naming this product code
40recalls 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 | Smith & Nephew, 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, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K113038 |
| Record published | 2015-08-29 |
| Record revised | 2023-09-07 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Distribution end date | 2018-05-09 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 71440436 | In distribution | |
| 71928023 | In distribution | |
| 71928024 | In distribution | |
| 71440454 | In distribution | |
| 71928026 | Withdrawn | |
| 71440136 | Withdrawn | |
| 71440130 | Withdrawn | |
| 71928022 | Withdrawn | |
| 71440138 | Withdrawn | |
| 71928027 | Withdrawn | |
| 71440460 | Withdrawn | |
| 71440134 | Withdrawn | |
| 71440126 | Withdrawn | |
| 71440128 | Withdrawn | |
| 71440132 | Withdrawn | |
| 71440140 | Withdrawn |
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 |
|---|---|
| K242711 | 2024-10-30 |
| K211512 | 2021-09-16 |
| K191211 | 2019-07-25 |
| K190085 | 2019-02-11 |
| K160738 | 2016-06-15 |
| K152315 | 2015-10-28 |
| K113038 | 2012-01-05 |
| K102069 | 2010-10-05 |
| K100197 | 2010-02-19 |
| K081351 | 2008-07-24 |
| K073175 | 2007-12-20 |
| K061779 | 2006-08-04 |
| K061011 | 2006-07-11 |
Recalls
7 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 |
|---|---|---|---|---|---|
| 2023-05-02 | Class II | Under Investigation by firm | Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries. The data identifies a potential signal that the performance is an outlier versus the st | 1596 units | |
| 2023-05-02 | Class II | Under Investigation by firm | Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries. The data identifies a potential signal that the performance is an outlier versus the st | 7531 units | |
| 2023-05-02 | Class II | Under Investigation by firm | Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries. The data identifies a potential signal that the performance is an outlier versus the st | 1994 units | |
| 2023-05-02 | Class II | Under Investigation by firm | Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries. The data identifies a potential signal that the performance is an outlier versus the st | 2146 units | |
| 2023-03-27 | Class II | Under Investigation by firm | A mispack occurred during the manufacturing process, resulting in the box incorrectly containing JOURNEY II UNI Tibia Insert Medical Size 1-2 12MM instead of the JOURNEY II UNI Tibia Insert Medial Size 7-8 8MM. | 12 units | |
| 2020-01-28 | Class II | Process design | The spike rail was manufactured with an oversized thru-hole which could potentially cause the dowel pin to fall out and the device to disassemble. | 195 units | 2023-12-11 |
| 2020-01-28 | Class II | Process design | The spike rail was manufactured with an oversized thru-hole which could potentially cause the dowel pin to fall out and the device to disassemble. | 200 units | 2023-12-11 |
| 2009-01-23 | Not classified | Device Design | The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instability and premature wear of the construct. | 58 units | 2011-03-25 |
| 2009-01-23 | Not classified | Device Design | The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instability and premature wear of the construct. | 859 units | 2011-03-25 |
| 2009-01-23 | Not classified | Device Design | The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instability and premature wear of the construct. | 904 units | 2011-03-25 |
| 2009-01-23 | Not classified | Device Design | The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instability and premature wear of the construct. | 941 units | 2011-03-25 |
| 2009-01-23 | Not classified | Device Design | The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instability and premature wear of the construct. | 1421 units | 2011-03-25 |
| 2009-01-23 | Not classified | Device Design | The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instability and premature wear of the construct. | 353 units | 2011-03-25 |
| 2009-01-23 | Not classified | Device Design | The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instability and premature wear of the construct. | 1150 units | 2011-03-25 |
| 2009-01-23 | Not classified | Device Design | The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instability and premature wear of the construct. | 71 units | 2011-03-25 |
| 2009-01-23 | Not classified | Device Design | The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instability and premature wear of the construct. | 1004 units | 2011-03-25 |
| 2009-01-23 | Not classified | Device Design | The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instability and premature wear of the construct. | 704 units | 2011-03-25 |
| 2009-01-23 | Not classified | Device Design | The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instability and premature wear of the construct. | 56 units | 2011-03-25 |
| 2009-01-23 | Not classified | Device Design | The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instability and premature wear of the construct. | 628 units | 2011-03-25 |
| 2009-01-23 | Not classified | Device Design | The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instability and premature wear of the construct. | 849 units | 2011-03-25 |
| 2009-01-23 | Not classified | Device Design | The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instability and premature wear of the construct. | 817 units | 2011-03-25 |
| 2009-01-23 | Not classified | Device Design | The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instability and premature wear of the construct. | 60 units | 2011-03-25 |
| 2009-01-23 | Not classified | Device Design | The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instability and premature wear of the construct. | 57 units | 2011-03-25 |
| 2009-01-23 | Not classified | Device Design | The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instability and premature wear of the construct. | 960 units | 2011-03-25 |
| 2009-01-23 | Not classified | Device Design | The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instability and premature wear of the construct. | 838 units | 2011-03-25 |
| 2009-01-23 | Not classified | Device Design | The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instability and premature wear of the construct. | 379 units | 2011-03-25 |
| 2009-01-23 | Not classified | Device Design | The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instability and premature wear of the construct. | 863 units | 2011-03-25 |
| 2009-01-23 | Not classified | Device Design | The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instability and premature wear of the construct. | 895 units | 2011-03-25 |
| 2009-01-23 | Not classified | Device Design | The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instability and premature wear of the construct. | 734 units | 2011-03-25 |
| 2009-01-23 | Not classified | Device Design | The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instability and premature wear of the construct. | 89 units | 2011-03-25 |
| 2009-01-23 | Not classified | Device Design | The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instability and premature wear of the construct. | 1064 units | 2011-03-25 |
| 2009-01-23 | Not classified | Device Design | The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instability and premature wear of the construct. | 813 units | 2011-03-25 |
| 2009-01-23 | Not classified | Device Design | The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instability and premature wear of the construct. | 721 units | 2011-03-25 |
| 2009-01-23 | Not classified | Device Design | The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instability and premature wear of the construct. | 97 units | 2011-03-25 |
| 2009-01-23 | Not classified | Device Design | The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instability and premature wear of the construct. | 1283 units | 2011-03-25 |
| 2009-01-23 | Not classified | Device Design | The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instability and premature wear of the construct. | 69 units | 2011-03-25 |
| 2009-01-23 | Not classified | Device Design | The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instability and premature wear of the construct. | 952 units | 2011-03-25 |
| 2009-01-23 | Not classified | Device Design | The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instability and premature wear of the construct. | 713 units | 2011-03-25 |
| 2009-01-23 | Not classified | Device Design | The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instability and premature wear of the construct. | 1324 units | 2011-03-25 |
| 2009-01-23 | Not classified | Device Design | The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instability and premature wear of the construct. | 1015 units | 2011-03-25 |
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.