NexGen
119 catalogue numbers from SSI004643, listed by Zimmer, Inc., United States, under Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer. 7 manufacturers in China are registered for this product code.
7manufacturers in China registered for this device type
119catalogue numbers in this listing
6510(k) clearances naming this product code
17recalls on this code
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (2), Zhejiang (2). 4 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 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| 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 |
Record
| Listed by | Zimmer, Inc., United States |
|---|---|
| FDA product code | KRO |
| Device type | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3510 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K152494 |
| Record published | 2018-08-23 |
| Record revised | 2022-03-22 (version 7) |
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, serial number |
| Sizes | Height 5 to 26 mm |
| Distribution end date | 2017-12-18 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SSI004643 | 5MM SZ 7 R | In distribution |
| 5989-06-21 | Size 6, 26 Degrees | In distribution |
| 5880-01-02 | Size 1 | In distribution |
| 5989-05-39 | Size 5, 20 mm Thickness | In distribution |
| 5880-40-14 | Height 14 mm | In distribution |
| 5880-14-02 | Size D | In distribution |
| 5989-05-29 | Size 5, 20 mm Thickness | In distribution |
| 5880-16-01 | Size F | In distribution |
| 5989-08-22 | Size 8, 22 Degrees | In distribution |
| 5990-32-10 | Size B, 5 mm Augment | In distribution |
| 5881-16-02 | Size F | In distribution |
| 5880-03-02 | Size 3 | In distribution |
| 5880-06 | Size 6 | In distribution |
| 5880-06-10 | Size 6, 10 mm, Thickness | In distribution |
| 5987-86 | In distribution | |
| 5880-20-14 | Size B | In distribution |
| 5880-60-23 | Height 23 mm | In distribution |
| 5880-50-20 | Size E | In distribution |
| SSI004647 | 10MM SZ 3 R | In distribution |
| 5880-60-12 | Size F | In distribution |
| 5989-03-38 | Size 3, 15 mm Thickness | In distribution |
| 5880-40-12 | Size D | In distribution |
| 00-5850-075-15 | Size E | In distribution |
| 5880-40-20 | Size D | In distribution |
| 5999-03-20 | Size 3, 16 Degrees | In distribution |
| SSI004639 | 5MM SZ 5 R | In distribution |
| SSI004657 | 10MM SZ 8 R | In distribution |
| 5880-30-12 | Size C | In distribution |
| 00-5850-075-15 | Size E | In distribution |
| SSI004651 | 10MM SZ 5 R | In distribution |
| 5880-60-17 | Size F | In distribution |
| SSI004655 | 10MM SZ 7 R | In distribution |
| 5880-13-01 | Size C | In distribution |
| 5880-20-26 | Height 26 mm | In distribution |
| SSI004641 | 5MM SZ 6 R | In distribution |
| 5989-05-22 | Size 5, 22 Degrees | In distribution |
| SSI004653 | 10MM SZ 6 R | In distribution |
| 5880-50-26 | Height 26 mm | In distribution |
| 5990-32-01 | Size B, 5 mm Augment | In distribution |
| 5989-04-29 | Size 4, 20 mm Thickness | In distribution |
| 5880-50-14 | Size E | In distribution |
| 5989-04-21 | Size 4, 26 Degrees | In distribution |
| SSI004649 | 10MM SZ 4 R | In distribution |
| 5990-32-21 | Size B, 10 mm Augment | In distribution |
| 5880-90-14 | Size D | In distribution |
| 5989-01-38 | Size 1, 15 mm Thickness | In distribution |
| 5880-15-02 | Size E | In distribution |
| 5989-02-27 | Size 2, 10 mm Thickness | In distribution |
| 5880-60-14 | Size F | In distribution |
| 5989-03-10 | Size 3, 10 mm Thickness | In distribution |
| 5989-06-29 | Size 6, 20 mm Thickness | In distribution |
| 5989-05-38 | Size 5, 15 mm Thickness | In distribution |
| 5880-50-23 | Size E | In distribution |
| 5987-33 | 5 and 10 mm | In distribution |
| SSI004645 | 5MM SZ 8 R | In distribution |
| 5880-02 | Size 2 | In distribution |
| 5989-08-26 | Size 8, 5 mm Thickness | In distribution |
| 5989-04-38 | Size 4, 15 mm Thickness | In distribution |
| 5880-20-17 | Height 17 mm | In distribution |
| 5881-13-01 | Size C | In distribution |
| 5880-15-01 | Size E | In distribution |
| 5880-12-01 | Size B | In distribution |
| 5989-06-38 | Size 6, 15 mm Thickness | In distribution |
| 5880-40-23 | Height 23 mm | In distribution |
| 5880-20-23 | Size B | In distribution |
| 5989-04-39 | Size 4, 20 mm Thickness | In distribution |
| 5880-30-26 | Height 26 mm | In distribution |
| 00-5850-075-12 | Size B | In distribution |
| 5880-04 | Size 4 | In distribution |
| 00-5850-075-12 | Size B | In distribution |
| 5880-40-26 | Height 26 mm | In distribution |
| 5989-03-29 | Size 3, 20 mm Thickness | In distribution |
| 5880-14-01 | Size D | In distribution |
| 00-5850-075-16 | Size F | In distribution |
| 5880-16-02 | Size F | In distribution |
| 00-5850-075-13 | Size C | In distribution |
| 5880-03-10 | Size 3, 10 mm, Thickness | In distribution |
| 5880-03 | Size 3 | In distribution |
| 5989-03-21 | Size 3, 26 Degrees | In distribution |
| 5880-13-02 | Size C | In distribution |
| 5880-02-02 | Size 2 | In distribution |
| 5880-30-20 | Height 20 mm | In distribution |
| 5880-40-17 | Size D | In distribution |
| 5987-20 | 26 Degree | In distribution |
| 00-5850-075-14 | Size D | In distribution |
| 5880-20-20 | Size B | In distribution |
| 5881-13-02 | Size C | In distribution |
| 00-5850-075-13 | Size C | In distribution |
| 5880-30-14 | Height 14 mm | In distribution |
| 5987-18 | 0 Degree | In distribution |
| 5989-07-27 | Height 10 mm | In distribution |
| 5880-90-12 | Size B | In distribution |
| 5880-60-26 | Height 26 mm | In distribution |
| 5880-05 | Size 5 | In distribution |
| SSI004637 | 5MM SZ 4 R | In distribution |
| 5987-29 | Sizes 7-8 | In distribution |
| 5880-12-02 | Size B | In distribution |
| 5989-04-10 | Size 4, 10 mm Thickness | In distribution |
| 00-5850-075-14 | Size D | In distribution |
| 5990-32-23 | Size B, 15 mm Augment | In distribution |
| 5880-30-17 | Size C | In distribution |
| 5989-35-31 | Size E | In distribution |
| SSI004635 | 5MM SZ 3 R | In distribution |
| 5880-90-13 | Size C | In distribution |
| 5989-01-10 | Size 1, 10 mm Thickness | In distribution |
| 5880-20-12 | Size B | In distribution |
| 5880-30-23 | Height 23 mm | In distribution |
| 5880-50-17 | Size E | In distribution |
| 00-5850-075-16 | Size F | In distribution |
| 5989-03-20 | Height 9.5 mm | In distribution |
| 5880-90-15 | Size E | In distribution |
| 5989-04-27 | Size 4, 10 mm Thickness | In distribution |
| 5880-60-20 | Size F | In distribution |
| 5989-08-38 | Size 8, 15 mm Thickness | In distribution |
| 5880-90-16 | Size F | In distribution |
| 5989-06-22 | Height 10 mm | In distribution |
| 5880-50-12 | Size E | In distribution |
| 5880-02-10 | Size 2, 10 mm, Thickness | In distribution |
| 5995-90-55 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Link Endo-Model EVO Knee System | Waldemar Link GmbH & Co. KG | 324 |
| Endo-Model Modular Knee Prosthesis System | Waldemar Link GmbH & Co. KG | 291 |
| LinkSymphoKnee | Waldemar Link GmbH & Co. KG | 263 |
| Evolution | Microport Orthopedics Inc. | 223 |
| Legion | Smith & Nephew, Inc. | 222 |
| OSS™ Orthopedic Salvage System | Biomet Orthopedics | 211 |
| Ustar II Knee System | United Orthopedic Corp. | 185 |
| “united” Ustar II Knee System | United Orthopedic Corp. | 162 |
| Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | Zimmer, Inc. | 157 |
| Finn Knee System | Biomet Orthopedics | 138 |
| Triathlon | Howmedica Osteonics Corp | 106 |
| Endo-Model SL Knee Prosthesis System | Waldemar Link GmbH & Co. KG | 94 |
Showing 12 of 109. All products under Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K192798 | 2020-12-10 |
| K150028 | 2015-02-06 |
| K110940 | 2011-07-01 |
| K070978 | 2007-07-03 |
| K013385 | 2002-01-09 |
| K810520 | 1981-03-26 |
Recalls Naming This Product
6 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 | 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 | 2006-10-12 | Not classified | Other | The polyethylene tibial articular surface may not lock into some of the tibial plates. | 18 | 2007-12-10 |
| Zimmer, Inc. | 510(k) number | 2004-08-03 | Not classified | Other | The polyethylene tibial bushing was omitted from the taper of the tibial plates. | 2004-09-13 | |
| Zimmer, Inc. | 510(k) number | 2004-08-03 | Not classified | Other | The polyethylene tibial bushing was omitted from the taper of the tibial plates. | 2004-09-13 |
Recalls
14 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 |
|---|---|---|---|---|---|
| 2017-08-01 | Class II | Package design/selection | The products being recalled exceeded the weight previously tested leading to a possibility of damage to the package and/or a compromised sterile barrier. | 3,350 units total | 2020-03-18 |
| 2017-02-28 | Class II | Packaging | Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures. | 9867 | 2018-02-27 |
| 2017-02-28 | Class II | Packaging | Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures. | 9867 | 2018-02-27 |
| 2017-02-28 | Class II | Packaging | Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures. | 9867 | 2018-02-27 |
| 2017-02-28 | Class II | Packaging | Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures. | 9867 | 2018-02-27 |
| 2017-02-28 | Class II | Packaging | Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures. | 9867 | 2018-02-27 |
| 2017-02-28 | Class II | Packaging | Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures. | 9867 | 2018-02-27 |
| 2017-02-28 | Class II | Packaging | Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures. | 9867 | 2018-02-27 |
| 2017-02-28 | Class II | Packaging | Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures. | 9867 | 2018-02-27 |
| 2017-02-28 | Class II | Packaging | Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures. | 9867 | 2018-02-27 |
| 2017-02-28 | Class II | Packaging | Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures. | 9867 | 2018-02-27 |
| 2014-02-25 | Class II | Storage | A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a result of the machined component being | 3638 units | 2015-03-24 |
| 2013-12-19 | Class II | Device Design | After evaluation of 13 complaints(0.4% rate) for hyper-extension of the Zimmer Segmental System, Zimmer is updating the related surgical technique and instructions for use to provide additional instructions and patient conditions that may p | 5305 distribution events | 2015-02-24 |
| 2013-12-19 | Class II | Device Design | After evaluation of 13 complaints(0.4% rate) for hyper-extension of the Zimmer Segmental System, Zimmer is updating the related surgical technique and instructions for use to provide additional instructions and patient conditions that may p | 5305 distribution events | 2015-02-24 |
| 2009-01-29 | Not classified | Packaging process control | The package contains 11 mm screws instead of the specified 6 mm screws. | 3 | 2009-11-12 |
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.