Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
157 catalogue numbers from 00-5850-040-20, 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
157catalogue 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) | K150028 |
| Record published | 2015-09-17 |
| Record revised | 2021-09-23 (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 |
| Sizes | Length 30 to 250 mm; height 6 to 26 mm; outer diameter 30 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00-5850-040-20 | Size D | In distribution |
| 00-5850-042-02 | Size B | In distribution |
| 00-5850-013-96 | Size C | In distribution |
| 00-5850-070-13 | Size C | In distribution |
| 00-5850-040-12 | Height 12 mm | In distribution |
| 00-5851-000-25 | In distribution | |
| 00-5852-052-14 | 14 mm Diameter | In distribution |
| 00-5850-012-96 | Size B | In distribution |
| 00-5850-048-09 | Length 90 mm | In distribution |
| 00-5850-050-17 | In distribution | |
| 00-5850-030-12 | In distribution | |
| 00-5850-012-02 | Size B | In distribution |
| 00-5852-054-18 | 18 mm Diameter | In distribution |
| 5020-02-009 | Height 9 mm | In distribution |
| 00-5851-000-15 | In distribution | |
| 00-5850-020-12 | In distribution | |
| 00-5850-040-26 | In distribution | |
| 00-5850-030-20 | Height 20 mm | In distribution |
| 6815-19-125 | Size 12.5 mm x 190 mm | In distribution |
| 00-5851-085-05 | In distribution | |
| 00-5852-050-13 | Length 130 mm | In distribution |
| 00-5850-013-96 | Size C | In distribution |
| 00-5852-054-19 | Length 250 mm | In distribution |
| 5020-01-006 | Height 6 mm | In distribution |
| 00-5852-054-16 | Length 250 mm | In distribution |
| 00-5851-002-10 | Size 2 | In distribution |
| 00-5850-043-01 | Size C | In distribution |
| 00-5851-000-36 | 4.5 mm Hex | In distribution |
| 00-5850-071-13 | Size C | In distribution |
| 00-5850-060-20 | In distribution | |
| 00-5850-030-23 | In distribution | |
| 00-5852-054-15 | Length 250 mm | In distribution |
| 00-5852-052-18 | 18 mm Diameter | In distribution |
| 00-5850-020-14 | In distribution | |
| 00-5850-046-06 | Length 60 mm | In distribution |
| 00-5851-001-12 | In distribution | |
| 00-5850-020-23 | Size B | In distribution |
| 00-5850-030-17 | In distribution | |
| 00-5850-050-14 | Height 14 mm | In distribution |
| 00-5850-046-14 | Length 140 mm | In distribution |
| 00-5850-046-22 | Length 220 mm | In distribution |
| 00-5850-046-18 | Length 180 mm | In distribution |
| 00-5852-042-17 | Outer Diameter 30 mm | In distribution |
| 00-5851-046-05 | Length 50 mm | In distribution |
| 00-5851-003-10 | Size 3 | In distribution |
| 00-5850-046-05 | Length 50 mm | In distribution |
| 00-5850-060-12 | Size F | In distribution |
| 00-5850-060-23 | Height 23 mm | In distribution |
| 00-5852-052-19 | 19 mm Diameter | In distribution |
| 00-5850-030-12 | Size C | In distribution |
| 00-5850-020-17 | Size B | In distribution |
| 00-5850-046-16 | Length 160 mm | In distribution |
| 00-5850-070-12 | Size B | In distribution |
| 00-5850-048-20 | Length 200 mm | In distribution |
| 00-5850-050-23 | Size E | In distribution |
| 00-5850-046-08 | Length 80 mm | In distribution |
| 00-5852-054-14 | Length 250 mm | In distribution |
| 00-5850-020-26 | In distribution | |
| 5020-10-009 | Size 9 mm | In distribution |
| 00-5850-071-12 | Size B | In distribution |
| 00-5850-040-14 | In distribution | |
| 00-5850-071-13 | Size C | In distribution |
| 00-5852-054-17 | Length 250 mm | In distribution |
| 5020-01-009 | Height 9 mm | In distribution |
| 00-5850-030-26 | Height 26 mm | In distribution |
| 00-5850-046-03 | Length 30 mm | In distribution |
| 00-5850-050-26 | In distribution | |
| 00-5850-020-12 | Size B | In distribution |
| 00-5850-050-14 | In distribution | |
| 00-5851-000-14 | In distribution | |
| 00-5851-001-10 | Size 1 | In distribution |
| 00-5850-020-17 | In distribution | |
| 00-5850-030-14 | Size C | In distribution |
| 00-5851-046-55 | Length 55 mm | In distribution |
| 00-5850-013-95 | Size C | In distribution |
| 00-5850-060-23 | In distribution | |
| 00-5850-020-26 | Height 26 mm | In distribution |
| 5020-02-021 | Height 21 mm | In distribution |
| 00-5852-050-18 | 18 mm Diameter | In distribution |
| 00-5850-070-13 | Size C | In distribution |
| 00-5850-046-45 | Length 45 mm | In distribution |
| 00-5850-000-11 | In distribution | |
| 00-5850-050-20 | Height 20 mm | In distribution |
| 00-5850-030-20 | In distribution | |
| 5020-04-016 | Height 16 mm | In distribution |
| 00-5850-060-26 | Height 26 mm | In distribution |
| 00-5850-070-12 | Size B | In distribution |
| 00-5850-040-17 | In distribution | |
| 00-5852-052-12 | 12 mm Diameter | In distribution |
| 5020-10-006 | Size 6 mm | In distribution |
| 00-5850-046-20 | Length 200 mm | In distribution |
| 00-5850-030-17 | Height 17 mm | In distribution |
| 00-5851-000-12 | Size 1 and 2 | In distribution |
| 00-5850-012-96 | Size B | In distribution |
| 5020-01-001 | 4 mm Hinge Kit | In distribution |
| 00-5850-030-23 | Height 23 mm | In distribution |
| 00-5852-050-14 | 14 mm Diameter | In distribution |
| 00-5850-013-02 | Size C | In distribution |
| 00-5852-050-15 | Length 130 mm | In distribution |
| 00-5852-052-16 | 16 mm Diameter | In distribution |
| 00-5852-050-12 | 12 mm Diameter | In distribution |
| 5020-04-021 | Height 21 mm | In distribution |
| 00-5851-000-13 | Size 3 | In distribution |
| 00-5850-060-26 | In distribution | |
| 00-5852-050-17 | Length 130 mm | In distribution |
| 00-5850-040-14 | Height 14 mm | In distribution |
| 00-5850-050-17 | Height 17 mm | In distribution |
| 00-5850-060-12 | In distribution | |
| 00-5850-060-14 | Size F | In distribution |
| 00-5852-042-09 | Outer Diameter 30 mm | In distribution |
| 00-5850-040-26 | Size D | In distribution |
| 00-5852-052-15 | Length 190 mm | In distribution |
| 00-5852-054-12 | 12 mm Diameter | In distribution |
| 00-5852-050-19 | Length 130 mm | In distribution |
| 00-5850-040-23 | Size D | In distribution |
| 00-5850-013-01 | Size C | In distribution |
| 00-5850-012-01 | Size B | In distribution |
| 00-5850-020-14 | Height 14 mm | In distribution |
| 00-5850-048-08 | Length 80 mm | In distribution |
| 00-5850-050-20 | In distribution | |
| 00-5851-000-20 | In distribution | |
| 00-5850-040-20 | In distribution | |
| 5020-04-012 | Height 12 mm | In distribution |
| 00-5850-071-12 | Size B | In distribution |
| 00-5850-042-01 | Size B | In distribution |
| 5020-03-016 | Height 16 mm | In distribution |
| 6815-19-135 | Size 13.5 mm x 190 mm | In distribution |
| 00-5850-060-14 | In distribution | |
| 00-5852-050-16 | 16 mm Diameter | In distribution |
| 00-5850-050-12 | Size E | In distribution |
| 00-5850-012-95 | Size B | In distribution |
| 00-5850-060-17 | Size F | In distribution |
| 00-5850-050-12 | In distribution | |
| 00-5850-050-26 | Size E | In distribution |
| 00-5850-030-14 | In distribution | |
| 00-5850-050-23 | In distribution | |
| 00-5850-046-04 | Length 40 mm | In distribution |
| 00-5850-060-20 | Height 20 mm | In distribution |
| 00-5850-046-10 | Length 100 mm | In distribution |
| 00-5852-054-13 | 13 mm Diameter | In distribution |
| 00-5850-020-20 | In distribution | |
| 00-5850-040-23 | In distribution | |
| 00-5850-060-17 | In distribution | |
| 00-5850-040-17 | Height 17 mm | In distribution |
| 00-5850-043-02 | Size C | In distribution |
| 00-5850-046-55 | Length 55 mm | In distribution |
| 00-5852-052-17 | 17 mm Diameter | In distribution |
| 00-5851-000-33 | In distribution | |
| 00-5850-030-26 | In distribution | |
| 00-5850-020-23 | In distribution | |
| 5020-01-016 | Height 16 mm | In distribution |
| 00-5850-020-20 | Height 20 mm | In distribution |
| 00-5850-040-12 | In distribution | |
| 00-5850-046-12 | Length 120 mm | In distribution |
| 00-5851-001-11 | In distribution | |
| 00-5852-052-13 | Length 190 mm | In distribution |
| 5020-02-012 | Height 12 mm | In distribution |
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 |
| Finn Knee System | Biomet Orthopedics | 138 |
| NexGen | Zimmer, Inc. | 119 |
| 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
3 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 | 2014-02-25 | 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 |
| Zimmer, Inc. | 510(k) number | 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 |
| Zimmer Austin, Inc. | 510(k) number | 2004-12-17 | Not classified | Other | Risk of adapter disassociation from mating components when assembled improperly or when subjected to high-stress femoral applications. | 121 units | 2007-11-27 |
Recalls
13 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 |
| 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 |
| 2004-08-03 | Not classified | Other | The polyethylene tibial bushing was omitted from the taper of the tibial plates. | 2004-09-13 | |
| 2004-08-03 | Not classified | Other | The polyethylene tibial bushing was omitted from the taper of the tibial plates. | 2004-09-13 |
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.