NexGen®
26 catalogue numbers from 5988-04-20, 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
26catalogue 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) | K152494 |
| Record published | 2015-09-17 |
| Record revised | 2023-02-03 (version 6) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5988-04-20 | Size 4, 16 Degrees | In distribution |
| 5988-07-26 | Size 7, 5 mm Thickness | In distribution |
| 5988-08-27 | Size 8, 10 mm Thickness | In distribution |
| 5988-05-23 | Size 5, 7 Degrees | In distribution |
| 5988-02-21 | Size 2, 26 Degrees | In distribution |
| 5988-08-22 | Size 8, 22 Degrees | In distribution |
| 5988-02-26 | Size 2, 5 mm Thickness | In distribution |
| 5988-02-27 | Size 2, 10 mm Thickness | In distribution |
| 5990-36-01 | Size F, 5 mm Augment | In distribution |
| 5988-04-22 | Size 4, 22 Degrees | In distribution |
| 5988-03-22 | Size 3, 22 Degrees | In distribution |
| 5988-07-22 | Size 7, 22 Degrees | In distribution |
| 5988-02-20 | Size 2, 16 Degrees | In distribution |
| 5988-03-23 | Size 3, 7 Degrees | In distribution |
| 5988-05-21 | Size 5, 26 Degrees | In distribution |
| 5988-06-21 | Size 6, 26 Degrees | In distribution |
| 5990-36-10 | Size F, 5 mm Augment | In distribution |
| 5990-36-20 | Size F, 10 mm Augment | In distribution |
| 5988-04-26 | Size 4, 5 mm Thickness | In distribution |
| 5988-08-20 | Size 8, 16 Degrees | In distribution |
| 5988-02-23 | Size 2, 7 Degrees | In distribution |
| 5988-06-27 | Size 6, 10 mm Thickness | In distribution |
| 5988-08-23 | Size 8, 7 Degrees | In distribution |
| 5988-04-23 | Size 4, 7 Degrees | In distribution |
| 5988-07-20 | Size 7, 16 Degrees | In distribution |
| 5988-08-21 | Size 8, 26 Degrees | 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
20 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 | 2025-01-06 | Class II | Process change control | It was identified internally that two commingle events occurred where the metal support post within the polyethylene articular surface was assembled incorrectly for three units within the scope. | 155 units | |
| Zimmer, Inc. | 510(k) number | 2025-01-06 | Class II | Process change control | It was identified internally that two commingle events occurred where the metal support post within the polyethylene articular surface was assembled incorrectly for three units within the scope. | 155 units | |
| Zimmer, Inc. | 510(k) number | 2023-05-19 | Class II | Under Investigation by firm | Device outer packaging was incorrectly labeled. | 2026-05-29 | |
| Zimmer, Inc. | 510(k) number | 2019-10-10 | Class II | Packaging change control | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 5,459,583 total devices | 2020-05-19 |
| Zimmer, Inc. | 510(k) number | 2018-10-31 | Class II | Process control | Screw is missing from the package | 19 units | 2019-04-08 |
| Zimmer, Inc. | 510(k) number | 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 |
| Zimmer, Inc. | 510(k) number | 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 |
| Zimmer, Inc. | 510(k) number | 2016-01-11 | Class II | Process control | LDPE bag containing the implant adheres to the highly polished implant surface. | 88389 | 2017-05-23 |
| Zimmer Manufacturing B.V. | 510(k) number | 2016-01-11 | Class II | Packaging | As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. The affected products are sterile. | 0 | 2017-04-13 |
| Zimmer, Inc. | 510(k) number | 2015-04-02 | Class II | Mixed-up of materials/components | The affected lot is being recalled because it was packaged without the locking screw. The locking screw packaged with the augment is used to fix the augment to the femoral component. This has the potential to delay surgery | 20 units | 2015-09-23 |
| Zimmer, Inc. | 510(k) number | 2010-09-15 | Not classified | Process design | These lots of Zimmer NexGen Complete Knee Solution LPS Femoral Component and Zimmer NexGen Complete Knee Solution LPS Flex Gender Femoral Component exhibit a nonconforming internal CAM radius. The condition is intermittent and not all dev | 192 all sizes of 5996 products | 2011-07-27 |
| Zimmer, Inc. | 510(k) number | 2010-09-15 | Not classified | Process design | These lots of Zimmer NexGen Complete Knee Solution LPS Femoral Component and Zimmer NexGen Complete Knee Solution LPS Flex Gender Femoral Component exhibit a nonconforming internal CAM radius. The condition is intermittent and not all dev | 192 all sizes of 5996 | 2011-07-27 |
| Zimmer, Inc. | 510(k) number | 2010-09-15 | Not classified | Process design | These lots of Zimmer NexGen Complete Knee Solution LPS Femoral Component and Zimmer NexGen Complete Knee Solution LPS Flex Gender Femoral Component exhibit a nonconforming internal CAM radius. The condition is intermittent and not all dev | 192 all sizes of 5996 | 2011-07-27 |
| Zimmer, Inc. | 510(k) number | 2010-09-15 | Not classified | Process design | These lots of Zimmer NexGen Complete Knee Solution LPS Femoral Component and Zimmer NexGen Complete Knee Solution LPS Flex Gender Femoral Component exhibit a nonconforming internal CAM radius. The condition is intermittent and not all dev | 192 all sizes of 5996. | 2011-07-27 |
| Zimmer, Inc. | 510(k) number | 2010-09-15 | Not classified | Process design | These lots of Zimmer NexGen Complete Knee Solution LPS Femoral Component and Zimmer NexGen Complete Knee Solution LPS Flex Gender Femoral Component exhibit a nonconforming internal CAM radius. The condition is intermittent and not all dev | 192 all sizes of 5996. | 2011-07-27 |
| Zimmer, Inc. | 510(k) number | 2010-09-15 | Not classified | Process design | These lots of Zimmer NexGen Complete Knee Solution LPS Femoral Component and Zimmer NexGen Complete Knee Solution LPS Flex Gender Femoral Component exhibit a nonconforming internal CAM radius. The condition is intermittent and not all dev | 158 all sizes of 5764 | 2011-07-27 |
| Zimmer, Inc. | 510(k) number | 2010-09-15 | Not classified | Process design | These lots of Zimmer NexGen Complete Knee Solution LPS Femoral Component and Zimmer NexGen Complete Knee Solution LPS Flex Gender Femoral Component exhibit a nonconforming internal CAM radius. The condition is intermittent and not all dev | 158 all sizes of 5764 | 2011-07-27 |
| Zimmer, Inc. | 510(k) number | 2010-09-15 | Not classified | Process design | These lots of Zimmer NexGen Complete Knee Solution LPS Femoral Component and Zimmer NexGen Complete Knee Solution LPS Flex Gender Femoral Component exhibit a nonconforming internal CAM radius. The condition is intermittent and not all dev | 158 all sizes of 5764 | 2011-07-27 |
| Zimmer, Inc. | 510(k) number | 2010-09-15 | Not classified | Process design | These lots of Zimmer NexGen Complete Knee Solution LPS Femoral Component and Zimmer NexGen Complete Knee Solution LPS Flex Gender Femoral Component exhibit a nonconforming internal CAM radius. The condition is intermittent and not all dev | 158 all sizes of 5764 | 2011-07-27 |
| Zimmer, Inc. | 510(k) number | 2009-02-26 | Not classified | Process control | Smaller diameter screws than required were included in the package. | 13 | 2011-02-28 |
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 |
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.